By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description OBJECTIVES/PURPOSE As part of the Clinical Trials Tools & Technologies organization, this role is accountable for the following activities: Manage standard processes governing end-to-end data delivery integration activities for EDC, eCOA, PK, LAB, BIOMARKER, and IMAGING data. Create Data Transfer Agreement (DTA) or Transfer Specification for 3rd party vendors in support of Clinical Trial. Perform training associated with integration activities for EDC, eCOA, PK, LAB, BIOMARKER, and IMAGING data. Responsible for identifying gaps and possible improvements to all clinical data cleaning tools and processes to ensure audit readiness and adherence to GCP guidelines. Ensure systems are fit for purpose and ensure all validation activities are thorough, documented and fit for purpose. Secures agreements with appropriate stakeholders (including but not limited to Clinical Operations, Clinical Supplies, IT, and Quality organizations) to develop technology strategies across Clinical Studies in alignment with established Takeda SOPs & Policies, and governance models. CORE ELEMENTS RELATED TO THIS ROLE Is accountable for system delivery life cycle, including deployment strategies, user training and management. Acts as a primary business change agent to ensure adoption of new capabilities and business process Serves as the first point of contact for Clinical Technology vendors when collaboration is needed to ensure established milestones and deliverables are met with the highest degree of quality. Leads study level technology & vendor oversight activities. Acts as a process expert for operational and oversight models. Confirms archival and inspection readiness of all Clinical Technology Trial Master File (TMF) documents. Participates in preparing function for submission readiness and may represent Clinical Trial Tools & Technologies (CT3) group in a formal inspection or audit. Follow designated strategy for study level technology & deployment and defines vendor oversight activities. Performs other duties as assigned. CORE ELEMENTS RELATED TO THIS ROLE The person in this role should have the following experience: Project management skills and experience managing implementation of integrations or implementation of clinical technologies like eCOA, IRT, EDC, Medical Devices, and Clinical Data Wearhouse for large drug development programs. Working knowledge and understanding of FDA and ICH regulations and industry standards and quality control principles. Solid experience applying System Development Life Cycle (SDLC) and developing strategies to address required changes to clinical trial technologies due to evolving GXP regulations. Experience with all phases of drug development. Leadership Moderate supervision required, should be able to function collaboratively (with some guidance) with all levels of employees Decision-making and Autonomy May lead study level negotiation and agreement for data transfer or integration on behalf of Takeda. Interaction Participate on complex, cross-organization technology and business process projects. Drive project delivery in complex Matrix organization Innovation Ability to identify new innovative trends in technology to better support clinical trials Support implementation of innovative solution in Takeda Complexity High complexity at program that include multiple projects and/or platforms. Domestic/international travel (5-20%) to other Takeda sites, strategic partners, and therapeutic area events may be required. EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: BS/BA required or MS preferred in a health-related, life science area or technology-related fields. Minimum of 6 years drug development experience. COMPENSATION Base Salary Range: $102,200 to $146,000 based on candidate professional experience level. Employee may also be eligible for Short-term and Long-term incentive benefits. Employees are eligible to participate in Medical, Dental. Vision, Life Insurance, 401(k), Charitable Contribution Match, Company Holidays, Personal & Vacation Days, Student Loan Repayment Program and Paid Volunteer Time Off. The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience. This position is currently classified as remote in accordance with Takeda's Hybrid and Remote Work policy. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations USA - MA - Virtual Worker Type Employee Worker Sub-Type Regular Time Type Full time
02/08/2023
Full time
By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description OBJECTIVES/PURPOSE As part of the Clinical Trials Tools & Technologies organization, this role is accountable for the following activities: Manage standard processes governing end-to-end data delivery integration activities for EDC, eCOA, PK, LAB, BIOMARKER, and IMAGING data. Create Data Transfer Agreement (DTA) or Transfer Specification for 3rd party vendors in support of Clinical Trial. Perform training associated with integration activities for EDC, eCOA, PK, LAB, BIOMARKER, and IMAGING data. Responsible for identifying gaps and possible improvements to all clinical data cleaning tools and processes to ensure audit readiness and adherence to GCP guidelines. Ensure systems are fit for purpose and ensure all validation activities are thorough, documented and fit for purpose. Secures agreements with appropriate stakeholders (including but not limited to Clinical Operations, Clinical Supplies, IT, and Quality organizations) to develop technology strategies across Clinical Studies in alignment with established Takeda SOPs & Policies, and governance models. CORE ELEMENTS RELATED TO THIS ROLE Is accountable for system delivery life cycle, including deployment strategies, user training and management. Acts as a primary business change agent to ensure adoption of new capabilities and business process Serves as the first point of contact for Clinical Technology vendors when collaboration is needed to ensure established milestones and deliverables are met with the highest degree of quality. Leads study level technology & vendor oversight activities. Acts as a process expert for operational and oversight models. Confirms archival and inspection readiness of all Clinical Technology Trial Master File (TMF) documents. Participates in preparing function for submission readiness and may represent Clinical Trial Tools & Technologies (CT3) group in a formal inspection or audit. Follow designated strategy for study level technology & deployment and defines vendor oversight activities. Performs other duties as assigned. CORE ELEMENTS RELATED TO THIS ROLE The person in this role should have the following experience: Project management skills and experience managing implementation of integrations or implementation of clinical technologies like eCOA, IRT, EDC, Medical Devices, and Clinical Data Wearhouse for large drug development programs. Working knowledge and understanding of FDA and ICH regulations and industry standards and quality control principles. Solid experience applying System Development Life Cycle (SDLC) and developing strategies to address required changes to clinical trial technologies due to evolving GXP regulations. Experience with all phases of drug development. Leadership Moderate supervision required, should be able to function collaboratively (with some guidance) with all levels of employees Decision-making and Autonomy May lead study level negotiation and agreement for data transfer or integration on behalf of Takeda. Interaction Participate on complex, cross-organization technology and business process projects. Drive project delivery in complex Matrix organization Innovation Ability to identify new innovative trends in technology to better support clinical trials Support implementation of innovative solution in Takeda Complexity High complexity at program that include multiple projects and/or platforms. Domestic/international travel (5-20%) to other Takeda sites, strategic partners, and therapeutic area events may be required. EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: BS/BA required or MS preferred in a health-related, life science area or technology-related fields. Minimum of 6 years drug development experience. COMPENSATION Base Salary Range: $102,200 to $146,000 based on candidate professional experience level. Employee may also be eligible for Short-term and Long-term incentive benefits. Employees are eligible to participate in Medical, Dental. Vision, Life Insurance, 401(k), Charitable Contribution Match, Company Holidays, Personal & Vacation Days, Student Loan Repayment Program and Paid Volunteer Time Off. The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience. This position is currently classified as remote in accordance with Takeda's Hybrid and Remote Work policy. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations USA - MA - Virtual Worker Type Employee Worker Sub-Type Regular Time Type Full time
Title: Human Resources Administrator Reports To: Director of Human Resources Position Type: Non-Exempt Location: YMCA of Greater Boston Administrative Office: Hybrid Model Position Summary: The YMCA of Greater Boston is seeking a dynamic, detail oriented and mission driven Human Resources Administrator to join our team. The HR Administrator plays a vital role as the first person of contact for HR-related queries from employees and external partners. The HR Administrator will provide process and transactional support for HR systems & processes; assist with a large volume of data entry and review related to team member business processes, including hires, terminations, salary adjustments, background checks and other confidential items. This position will also monitor various HR inboxes and respond or escalate to the appropriate team, including COE, HR Strategic Partners, or Leadership. The successful candidate must have excellent attention to detail, outstanding communication skills, ability to multi-task in a fast-paced environment and handle sensitive information with tact and confidentiality. Key Responsibilities: Serve as the point of contact for HR administrative support. In partnership with the Manager HRIS, processes personnel related transactions and maintains accurate and up to date information in our HRIS system as appropriate. Ensure all submitted employee change requests are processed accurately and timely. Prepares HR files for EEC and DPH audits. Assemble and review new hire paperwork for completeness, including I-9 verification and CORI/SORI forms. Follows up with new hires regarding incomplete or missing paperwork. Submit completed paperwork to recruitment team for final approval to ensure employee is cleared to work. Create and maintain accurate documents and employee records. Prepare for and process all seasonal transfers. Work with department managers to ensure all new hires are fully on-boarded into our HRIS Systems. Work collaboratively with staff, managers and the HR Department to problem solve, relay, and explain to employees' changes/updates in the HRIS System (ADP), educate/train time approvers, troubleshoot payroll and benefit issues under the direction of Human Resources Business Partners and HRIS Manager. Serve as a resource to staff around HR-related procedures, processes, and programs. Assist as necessary with new employee orientations. Show resolve in seeking solutions to problems both within and beyond areas of direct responsibility. Other duties as assigned. Education, Skills, and Experience Requirements: Bachelor's Degree in HR, Business or an equivalent combination of education, training, and experience. Minimum of 2 years of HR administrative experience, preferably in a fast-paced, professional human resources environment. Demonstrated experience with HR software, like HRIS or HRMS. Experience with ADP Workforce Now, in particular, a strong plus. Strong attention to detail. Excellent follow up and follow through skills. Strong communication skills, both written and oral. Strong customer service-oriented work ethic, with focus on problem-solving and empowering and educating employees. Ability to work collaboratively and effectively with a creative and diverse group of people and as part of a team. Strong independent decision-making skills. Discretion with confidential information. Excellent organizational, customer service, and verbal and written communications skills. Knowledge of personnel practices, rules, and regulations highly desired. Advanced proficiency of Microsoft Office suite of products, including Word, Excel, Outlook, and Teams. Physical Demands: Regular and reliable attendance is an essential function of the position. Work is normally performed in a typical interior/office work environment. No or very limited physical effort required. No or very limited exposure to physical risk. Why Work at the Y? The YMCA of Greater Boston is an incredible place to have a fulfilling career or enjoy part-time employment - all while we are supporting and strengthening our communities, because our community is our cause. When you join us in your career here, you can look forward to: Developing your leadership skills in a caring, challenging & diverse working environment. Exploring a wide range of opportunities as you learn new skills and functions. Shaping the future of young children while making a difference each day for our communities and each other. Engaging in YMCA career training programs and working alongside those who have the same passion. A healthy work/life balance. Comprehensive Benefits Including: Quarterly Professional Development. FREE YMCA Membership for you. Discount on Specialty Programs like Personal Training and Swimming Lessons. Discounted or FREE family membership. Robust Retirement Plan up to 8%. Health, Dental, and Vision Benefit Package. Vacation and Sick Time (for both Full and PT staff!).
02/08/2023
Full time
Title: Human Resources Administrator Reports To: Director of Human Resources Position Type: Non-Exempt Location: YMCA of Greater Boston Administrative Office: Hybrid Model Position Summary: The YMCA of Greater Boston is seeking a dynamic, detail oriented and mission driven Human Resources Administrator to join our team. The HR Administrator plays a vital role as the first person of contact for HR-related queries from employees and external partners. The HR Administrator will provide process and transactional support for HR systems & processes; assist with a large volume of data entry and review related to team member business processes, including hires, terminations, salary adjustments, background checks and other confidential items. This position will also monitor various HR inboxes and respond or escalate to the appropriate team, including COE, HR Strategic Partners, or Leadership. The successful candidate must have excellent attention to detail, outstanding communication skills, ability to multi-task in a fast-paced environment and handle sensitive information with tact and confidentiality. Key Responsibilities: Serve as the point of contact for HR administrative support. In partnership with the Manager HRIS, processes personnel related transactions and maintains accurate and up to date information in our HRIS system as appropriate. Ensure all submitted employee change requests are processed accurately and timely. Prepares HR files for EEC and DPH audits. Assemble and review new hire paperwork for completeness, including I-9 verification and CORI/SORI forms. Follows up with new hires regarding incomplete or missing paperwork. Submit completed paperwork to recruitment team for final approval to ensure employee is cleared to work. Create and maintain accurate documents and employee records. Prepare for and process all seasonal transfers. Work with department managers to ensure all new hires are fully on-boarded into our HRIS Systems. Work collaboratively with staff, managers and the HR Department to problem solve, relay, and explain to employees' changes/updates in the HRIS System (ADP), educate/train time approvers, troubleshoot payroll and benefit issues under the direction of Human Resources Business Partners and HRIS Manager. Serve as a resource to staff around HR-related procedures, processes, and programs. Assist as necessary with new employee orientations. Show resolve in seeking solutions to problems both within and beyond areas of direct responsibility. Other duties as assigned. Education, Skills, and Experience Requirements: Bachelor's Degree in HR, Business or an equivalent combination of education, training, and experience. Minimum of 2 years of HR administrative experience, preferably in a fast-paced, professional human resources environment. Demonstrated experience with HR software, like HRIS or HRMS. Experience with ADP Workforce Now, in particular, a strong plus. Strong attention to detail. Excellent follow up and follow through skills. Strong communication skills, both written and oral. Strong customer service-oriented work ethic, with focus on problem-solving and empowering and educating employees. Ability to work collaboratively and effectively with a creative and diverse group of people and as part of a team. Strong independent decision-making skills. Discretion with confidential information. Excellent organizational, customer service, and verbal and written communications skills. Knowledge of personnel practices, rules, and regulations highly desired. Advanced proficiency of Microsoft Office suite of products, including Word, Excel, Outlook, and Teams. Physical Demands: Regular and reliable attendance is an essential function of the position. Work is normally performed in a typical interior/office work environment. No or very limited physical effort required. No or very limited exposure to physical risk. Why Work at the Y? The YMCA of Greater Boston is an incredible place to have a fulfilling career or enjoy part-time employment - all while we are supporting and strengthening our communities, because our community is our cause. When you join us in your career here, you can look forward to: Developing your leadership skills in a caring, challenging & diverse working environment. Exploring a wide range of opportunities as you learn new skills and functions. Shaping the future of young children while making a difference each day for our communities and each other. Engaging in YMCA career training programs and working alongside those who have the same passion. A healthy work/life balance. Comprehensive Benefits Including: Quarterly Professional Development. FREE YMCA Membership for you. Discount on Specialty Programs like Personal Training and Swimming Lessons. Discounted or FREE family membership. Robust Retirement Plan up to 8%. Health, Dental, and Vision Benefit Package. Vacation and Sick Time (for both Full and PT staff!).
Expedient is seeking an Area Vice President (AVP) of Sales to lead the sales team in our Boston market. The AVP focuses primarily on and executes against the market city's revenue objectives. This is a great opportunity for someone with solid sales and sales leadership experience in a related IT services, cloud and/or infrastructure-as-a-service business. This position will play a pivotal role in our growth strategy and the future, continued success of the company. A successful AVP should possess technical aptitude, an existing network of contacts in the market city and sales leadership experience that will be vital to help develop our sales team in Boston. Who We're Looking For in an Area Vice President of Sales 6 + years of successful IT solutions-based sales experience in cloud, data center infrastructure, hardware and/or managed services in the Boston area 5+ years of a proven track record in successfully leading sales teams Bachelor's degree in business, IT or related discipline preferred Solid experience in forecasting sales on a monthly/quarterly basis with a high degree of accuracy, and developing the team's overall go-to-market strategy Understands & applies outcomes-based selling and can develop the sales team accordingly Strong understanding of pipeline and sales funnel management disciplines What You'll Be Doing as Area Vice President of Sales Attract, hire, educate, coach and retain a consistently high-performing sales team, which includes New Business Account Executives and Existing Client Advisors Develop and maintain a bench of qualified sales candidates Develop strategic performance plans for each team member and provide ongoing support to assist them in achieving their respective targets Provide accurate sales forecasting, planning and budgeting on a monthly, quarterly and yearly basis Salary for this position is commensurate with experience. Starting base salary of approximately $140K to $180K and a variable, uncapped commission plan. On Target Earnings at plan is approximately $275k to $325k annually. For more information about Expedient please visit our website at WORKING FOR EXPEDIENT We place a high value on learning and staying current and competitive in the tech arena. Education and training are available to our employees through a robust, employee-driven training and tuition reimbursement program costs are covered by Expedient 100%. Employee benefits include 3 weeks of paid time off per year, parental leave, top-tier, affordable medical, dental, vision insurance, 401(k) with a generous match. We offer hybrid work environment, paid parking, fully stocked kitchens, gym-membership assistance and many other benefits for our employees. Expedient is an equal opportunity employer. Qualified applicants will receive fair and equal consideration for employment without regard to their race, color, religion, national origin, gender, protected veteran status, disability, or any other characteristic protected by law. 81q8XqwBvB
02/08/2023
Full time
Expedient is seeking an Area Vice President (AVP) of Sales to lead the sales team in our Boston market. The AVP focuses primarily on and executes against the market city's revenue objectives. This is a great opportunity for someone with solid sales and sales leadership experience in a related IT services, cloud and/or infrastructure-as-a-service business. This position will play a pivotal role in our growth strategy and the future, continued success of the company. A successful AVP should possess technical aptitude, an existing network of contacts in the market city and sales leadership experience that will be vital to help develop our sales team in Boston. Who We're Looking For in an Area Vice President of Sales 6 + years of successful IT solutions-based sales experience in cloud, data center infrastructure, hardware and/or managed services in the Boston area 5+ years of a proven track record in successfully leading sales teams Bachelor's degree in business, IT or related discipline preferred Solid experience in forecasting sales on a monthly/quarterly basis with a high degree of accuracy, and developing the team's overall go-to-market strategy Understands & applies outcomes-based selling and can develop the sales team accordingly Strong understanding of pipeline and sales funnel management disciplines What You'll Be Doing as Area Vice President of Sales Attract, hire, educate, coach and retain a consistently high-performing sales team, which includes New Business Account Executives and Existing Client Advisors Develop and maintain a bench of qualified sales candidates Develop strategic performance plans for each team member and provide ongoing support to assist them in achieving their respective targets Provide accurate sales forecasting, planning and budgeting on a monthly, quarterly and yearly basis Salary for this position is commensurate with experience. Starting base salary of approximately $140K to $180K and a variable, uncapped commission plan. On Target Earnings at plan is approximately $275k to $325k annually. For more information about Expedient please visit our website at WORKING FOR EXPEDIENT We place a high value on learning and staying current and competitive in the tech arena. Education and training are available to our employees through a robust, employee-driven training and tuition reimbursement program costs are covered by Expedient 100%. Employee benefits include 3 weeks of paid time off per year, parental leave, top-tier, affordable medical, dental, vision insurance, 401(k) with a generous match. We offer hybrid work environment, paid parking, fully stocked kitchens, gym-membership assistance and many other benefits for our employees. Expedient is an equal opportunity employer. Qualified applicants will receive fair and equal consideration for employment without regard to their race, color, religion, national origin, gender, protected veteran status, disability, or any other characteristic protected by law. 81q8XqwBvB
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as a Research Scientist where you will join a team of motivated and enthusiastic scientists in the Cambridge MA location and be directly involved in antibody or biologic discovery and engineering efforts. You will be a key driver of NGS-based approaches supporting the antibody-discovery efforts. As part of the Global Biologics team, you will report to the Associate Scientific Director and work with the Biotherapeutic Engineering team, the discovery and engineering group within Takeda's Global Biologics Department. How you will contribute: A self-starter, being able to set-up and lead NGS workflows, focusing on sequence analysis and visualization, of antibody repertoires, from various antibody discovery sources. Provide guidance to team members, on sample preparation for analysis. Lead expansion of existing NGS capabilities, for new functions. Familiarity with 10X Genomics platforms is an advantage. Work closely with project team leads to develop project strategies and to coordinate work within Global Biologics organization. Upload and track data into data management systems and maintain detailed electronic notebook. Work with a fast pace to meet program and team needs. Effective resource and time management is essential. Effective oral and written communication as well as strong interpersonal skills required. Hard working, enthusiastic, self-motivated, team-oriented with a strong collaborative spirit. Minimum Requirements/Qualifications: PhD or MS (6+ years experience) in Molecular Biology, Protein Engineering, Biochemistry or similar. Strong scientific expertise and knowledge in all aspects pertaining to the NGS workflow, in the context of antibody discovery/repertoire analysis. A good understanding of antibody structure and function, and various antibody display platforms. Strong computational/sequence analysis capabilities. Experience with In-silico tools for protein structure modeling, is desirable, not necessary. What Takeda can offer you: Comprehensive Healthcare: Medical, Dental, and Vision Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs and company match of charitable contributions Family Planning Support Flexible Work Paths Tuition reimbursement More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
02/08/2023
Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as a Research Scientist where you will join a team of motivated and enthusiastic scientists in the Cambridge MA location and be directly involved in antibody or biologic discovery and engineering efforts. You will be a key driver of NGS-based approaches supporting the antibody-discovery efforts. As part of the Global Biologics team, you will report to the Associate Scientific Director and work with the Biotherapeutic Engineering team, the discovery and engineering group within Takeda's Global Biologics Department. How you will contribute: A self-starter, being able to set-up and lead NGS workflows, focusing on sequence analysis and visualization, of antibody repertoires, from various antibody discovery sources. Provide guidance to team members, on sample preparation for analysis. Lead expansion of existing NGS capabilities, for new functions. Familiarity with 10X Genomics platforms is an advantage. Work closely with project team leads to develop project strategies and to coordinate work within Global Biologics organization. Upload and track data into data management systems and maintain detailed electronic notebook. Work with a fast pace to meet program and team needs. Effective resource and time management is essential. Effective oral and written communication as well as strong interpersonal skills required. Hard working, enthusiastic, self-motivated, team-oriented with a strong collaborative spirit. Minimum Requirements/Qualifications: PhD or MS (6+ years experience) in Molecular Biology, Protein Engineering, Biochemistry or similar. Strong scientific expertise and knowledge in all aspects pertaining to the NGS workflow, in the context of antibody discovery/repertoire analysis. A good understanding of antibody structure and function, and various antibody display platforms. Strong computational/sequence analysis capabilities. Experience with In-silico tools for protein structure modeling, is desirable, not necessary. What Takeda can offer you: Comprehensive Healthcare: Medical, Dental, and Vision Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs and company match of charitable contributions Family Planning Support Flexible Work Paths Tuition reimbursement More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Takeda is a global, values-based, R&D-driven, top 10 biopharmaceutical leader committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Our Data Sciences Institute (DSI) is made up of more than 250 quantitative scientists who harness the insight of data and digital to speed the development of highly innovative treatments to patients. These scientists (from statistics, programming, outcomes research and epidemiology, quantitative clinical pharmacology, digital strategy, library sciences and data architecture/governance) bring their expertise to our global program teams and re-imagine our disciplines. They work with novel data streams, including real-world data and digital tools, and apply advanced analytics including artificial intelligence and automation. As part of DSI, the Statistics and Quantitative Sciences (SQS) at Takeda is looking to add individuals to our team that are team oriented, collaborative, strong understanding of the statistical programming function, exceptional leaders and innovators. SQS aspires to bring safe and effective medications to the patients with our quantitative skills. We design efficient trials, contribute to clinical development strategies, perform high quality statistical analyses, and pursue operational excellence. To attract and retain the very best talent, we in Takeda SQS are open to flexible or remote working for some roles. Such roles will have a connection to a Takeda R&D center. How you will contribute: Serve as leader, expert, mentor and manager of group supporting translational and exploratory statistical analyses in support of Takeda R&D assets across Therapeutic Area Units (TAUs) Drive collaborations with biomarker, translational and clinical scientists across TAUs to enable biomarker development strategies for early clinical development decision making Strategize and prioritize opportunities for Quantitative Sciences group AI/ML, RWE, advanced analytics and modeling to maximize impact on the organization Lead implementation of strategies, goals, and priorities for the Quantitative Sciences group within the broader SQS organization Oversee and ensure achievement of all deliverables and milestones for programs across TAUs Align analytical efforts and resource allocation with TAU strategies, portfolio priorities, partner lines work, and with Digital and Technology Manage, mentor and grow interdisciplinary team of biostatisticians, computational scientists and data scientists to integrate translational and early clinical assets to advance R&D programs Promote statistical innovation and collaborations in data analytics for exploratory biomarker research representing Quantitative Sciences group Develop and manage relationships with the external research community; serve as the scientific point person at meetings with KOLs, conferences, and industry events Provide statistical leadership in the development and review of the study synopsis, protocol, statistical and exploratory analysis plans, clinical study report, and other regulatory submission documents, ensuring accurate and statistically valid deliverables within and across TAUs as appropriate Provide strategic statistical input to feasibility assessments, development and submission plans, and defense of regulatory submissions across TAUs, including timelines Identify and interact with external statistical experts for issues related to design, methodology and results as the primary contact and spokesperson Increase efficiency of the Statistics function through development of standard and/or innovative analysis methodology, data presentations, and sharing of best practices Leverage scientific expertise for strategic statistical leadership by providing recommendations and statistical consultations to management Monitor and contribute to industry advances in statistical methods to optimize study designs and statistical analyses techniques, and lead implementation of innovative approaches within and/or across TAUs as appropriate. Demonstrate leadership of TAU, BU, or SQS function or specialty area in preclinical / clinical / translational Act as a cross functional leader and accountable decision maker that has direct impact on R&D Define and contribute to strategic vision, mission and respective implementation for the promotion of SQS within TAUs, BUs, and R&D functions Identify opportunities and create delivery for DSI mission to make R&D business impact Be involved in mentorship, matrix or direct management of large team of SQS colleagues Be accountable for growth and development of SQS and DSI talent profile Show influential leadership both within and outside of Takeda in area of expertise Minimum Requirements/Qualifications: Applicant for this position should have degree in statistics/biostatistics or in other equivalent quantitative sciences (e.g., Applied Mathematics, Physics, Engineering or related quantitative field) along with the following specific credentials: PhD with 12+ years experience or MS with 15 years experience Provide strategic leadership Mobilize high performance from teams Influence beyond SQS and DSI Knowledge of the pharmaceutical drug discovery and development process with a relevant track record of R&D hands-on work and leadership Experience in the early clinical stages of drug development. Expertise and track record of implementation of advanced statistical modeling across several TAUs Expertise in biomarker and outcomes instrument validation for clinical trial endpoint use Pragmatic leader with a focus on driving the teams using fit-for-purpose philosophy and a track record of creativity and innovation Track record of integrating discovery/medical and statistical best practices into translational and clinical research to improve reproducibility, efficacy, safety of the exploratory endpoints across phases of drug development Demonstrated ability to work collaboratively with research project teams in both preclinical and clinical development programs Ability to translate/explain complex statistical concepts to non-experts; ability to speak across disciplines of Quantitative Sciences umbrella: statistics, engineering, applied mathematics, computational biology, pharmacokinetic/pharmacodynamic modeling, and others Excellent communication and presentation skills Expertise in statistical programming, modeling and simulations Technical expertise across a TAU - understands the TAU strategy to lead and drive optimized methodology in drug R&D Leadership in TAU and functional methodology decision making to optimize the likelihood of drug R&D success Solid technical background in statistical and signal processing methods of analysis for imaging, physiological, sensor data Capability to create technical strategic vision and implement long-term innovation that is aligned with global regulatory and payer policies and trends Capability to create major technical and methodology projects and guide them to implementation across R&D The ability to establish external network to facilitate collaborations across industry, government, and academia Strong track record of scientific publications, both methodological developments as well as applied Track record of technical proficiency in hands data analysis and scientific programming using variety of languages such as SAS, R, MATLAB, python, Julia, C/C++ What Takeda can offer you: Comprehensive Healthcare: Medical, Dental, and Vision Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs and company match of charitable contributions Family Planning Support Flexible Work Paths Tuition reimbursement More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy. Base Salary Range: $194,000 to $278,000 . click apply for full job details
02/08/2023
Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Takeda is a global, values-based, R&D-driven, top 10 biopharmaceutical leader committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Our Data Sciences Institute (DSI) is made up of more than 250 quantitative scientists who harness the insight of data and digital to speed the development of highly innovative treatments to patients. These scientists (from statistics, programming, outcomes research and epidemiology, quantitative clinical pharmacology, digital strategy, library sciences and data architecture/governance) bring their expertise to our global program teams and re-imagine our disciplines. They work with novel data streams, including real-world data and digital tools, and apply advanced analytics including artificial intelligence and automation. As part of DSI, the Statistics and Quantitative Sciences (SQS) at Takeda is looking to add individuals to our team that are team oriented, collaborative, strong understanding of the statistical programming function, exceptional leaders and innovators. SQS aspires to bring safe and effective medications to the patients with our quantitative skills. We design efficient trials, contribute to clinical development strategies, perform high quality statistical analyses, and pursue operational excellence. To attract and retain the very best talent, we in Takeda SQS are open to flexible or remote working for some roles. Such roles will have a connection to a Takeda R&D center. How you will contribute: Serve as leader, expert, mentor and manager of group supporting translational and exploratory statistical analyses in support of Takeda R&D assets across Therapeutic Area Units (TAUs) Drive collaborations with biomarker, translational and clinical scientists across TAUs to enable biomarker development strategies for early clinical development decision making Strategize and prioritize opportunities for Quantitative Sciences group AI/ML, RWE, advanced analytics and modeling to maximize impact on the organization Lead implementation of strategies, goals, and priorities for the Quantitative Sciences group within the broader SQS organization Oversee and ensure achievement of all deliverables and milestones for programs across TAUs Align analytical efforts and resource allocation with TAU strategies, portfolio priorities, partner lines work, and with Digital and Technology Manage, mentor and grow interdisciplinary team of biostatisticians, computational scientists and data scientists to integrate translational and early clinical assets to advance R&D programs Promote statistical innovation and collaborations in data analytics for exploratory biomarker research representing Quantitative Sciences group Develop and manage relationships with the external research community; serve as the scientific point person at meetings with KOLs, conferences, and industry events Provide statistical leadership in the development and review of the study synopsis, protocol, statistical and exploratory analysis plans, clinical study report, and other regulatory submission documents, ensuring accurate and statistically valid deliverables within and across TAUs as appropriate Provide strategic statistical input to feasibility assessments, development and submission plans, and defense of regulatory submissions across TAUs, including timelines Identify and interact with external statistical experts for issues related to design, methodology and results as the primary contact and spokesperson Increase efficiency of the Statistics function through development of standard and/or innovative analysis methodology, data presentations, and sharing of best practices Leverage scientific expertise for strategic statistical leadership by providing recommendations and statistical consultations to management Monitor and contribute to industry advances in statistical methods to optimize study designs and statistical analyses techniques, and lead implementation of innovative approaches within and/or across TAUs as appropriate. Demonstrate leadership of TAU, BU, or SQS function or specialty area in preclinical / clinical / translational Act as a cross functional leader and accountable decision maker that has direct impact on R&D Define and contribute to strategic vision, mission and respective implementation for the promotion of SQS within TAUs, BUs, and R&D functions Identify opportunities and create delivery for DSI mission to make R&D business impact Be involved in mentorship, matrix or direct management of large team of SQS colleagues Be accountable for growth and development of SQS and DSI talent profile Show influential leadership both within and outside of Takeda in area of expertise Minimum Requirements/Qualifications: Applicant for this position should have degree in statistics/biostatistics or in other equivalent quantitative sciences (e.g., Applied Mathematics, Physics, Engineering or related quantitative field) along with the following specific credentials: PhD with 12+ years experience or MS with 15 years experience Provide strategic leadership Mobilize high performance from teams Influence beyond SQS and DSI Knowledge of the pharmaceutical drug discovery and development process with a relevant track record of R&D hands-on work and leadership Experience in the early clinical stages of drug development. Expertise and track record of implementation of advanced statistical modeling across several TAUs Expertise in biomarker and outcomes instrument validation for clinical trial endpoint use Pragmatic leader with a focus on driving the teams using fit-for-purpose philosophy and a track record of creativity and innovation Track record of integrating discovery/medical and statistical best practices into translational and clinical research to improve reproducibility, efficacy, safety of the exploratory endpoints across phases of drug development Demonstrated ability to work collaboratively with research project teams in both preclinical and clinical development programs Ability to translate/explain complex statistical concepts to non-experts; ability to speak across disciplines of Quantitative Sciences umbrella: statistics, engineering, applied mathematics, computational biology, pharmacokinetic/pharmacodynamic modeling, and others Excellent communication and presentation skills Expertise in statistical programming, modeling and simulations Technical expertise across a TAU - understands the TAU strategy to lead and drive optimized methodology in drug R&D Leadership in TAU and functional methodology decision making to optimize the likelihood of drug R&D success Solid technical background in statistical and signal processing methods of analysis for imaging, physiological, sensor data Capability to create technical strategic vision and implement long-term innovation that is aligned with global regulatory and payer policies and trends Capability to create major technical and methodology projects and guide them to implementation across R&D The ability to establish external network to facilitate collaborations across industry, government, and academia Strong track record of scientific publications, both methodological developments as well as applied Track record of technical proficiency in hands data analysis and scientific programming using variety of languages such as SAS, R, MATLAB, python, Julia, C/C++ What Takeda can offer you: Comprehensive Healthcare: Medical, Dental, and Vision Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs and company match of charitable contributions Family Planning Support Flexible Work Paths Tuition reimbursement More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy. Base Salary Range: $194,000 to $278,000 . click apply for full job details
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: The Systems Biology Scientist II will be part of a team focused on bioinformatics and computational biology support of translational pre-clinical data analysis in neuroscience therapeutic area. The scientist will apply expertise in bioinformatics, genomics and computational biology to integrate and analyze publicly available and proprietary molecular profiling 'omics datasets and phenotypic data to support Takeda translational preclinical projects. Generate data insights to drive neuroscience projects, interface with research teams and support the data analysis and interpretation needs of neuroscience projects Drive collaborations with internal groups, external partners, including CROs and academia for data analysis and machine learning. Join Takeda as a Scientist II in our Systems Biology team, based in Cambridge, MA. How you will contribute: ACCOUNTABILITIES Performs advanced analysis of DNA-seq, RNA-seq, ChIP-seq and other sequencing data in combination with publicly available genomics data to extract novel and biologically meaningful information. Apply various computational biology methods for translational research, including systems biology, pathway/network analysis, machine learning, GWAS, TWAS, PGS, etc. Method development for translational research, e.g. predictive modeling for patient stratification and disease indication selection. Integrates genetics, transcriptomics, epigenetics, proteomics and literature data to strengthen understanding of diseases and treatment perturbations. Utilizes multiple approaches for analyses of genetic variation, pathways and networks. Interpret preclinical datasets using appropriate statistical methods. Create visualizations, interpret high dimensional data and explain results to cross-functional teams. Apply machine learning algorithms to large-scale datasets Schedule and execute tasks to meet deadlines. Maintain and share code. Writes study reports and presents data effectively in all settings and with participants of all levels of the organization. DIMENSIONS AND ASPECTS Demonstrates in-depth knowledge of currently assigned research methods Understands the basics of oligonucleotide synthesis Demonstrates basic knowledge of science/technology outside specific discipline Recognizes problems and considers the significance of irregularities Technical/Functional (Line) Expertise Solid background in genetics and genomics with an understanding of neurodevelopmental and/or neurodegerative disorders, and ability to interpret genetic and genomics findings in disease context. Solid hands on experience with GWAS/PheWAS/eQTL/pQTL analyses, WES/WGS sequencing data analyses, and rare variants analyses required. Experience in using pathway-based approaches, multivariate analyses, polygenic risk score analyses, machine learning Hands on experience in using public human databases Be expert in sequencing data analysis such as RNAseq, DNAseq, scRNA-seq, etc. Keeps current with emerging trends in bioinformatics and computational biology. Independently keep abreast of current literature in computational biology for drug discovery and development. Solid knowledge of Unix, command lines interfaces, and fluency in common scripting and/or programming language (e.g. R, Python, Perl, Java, C/C++) used for bioinformatics analysis. Familiarity with parallel computing, relational databases (e.g., SQL) and cloud computing or distributed computing (i.e. AWS). Familiarity with popular public domain data sources and programmatic interfaces Excellent problem solving, communication, presentation, and interpersonal skills; able to provide input on timelines and resource needs as indicated Independent, self-starting and supportive of team-based research and able to work effectively in a matrix organization Background in/experience with Neuroscience is a plus Minimum Requirements/Qualifications: PhD in bioinformatics, computational biology, or a related field with 2+ years of postdoctoral or industry experience, or MS with 8+ years' experience, or BS with 10+ years' experience Previous industry experience, preferably with big pharmaceutical companies and on clinical programs. What Takeda can offer you: Comprehensive Healthcare: Medical, Dental, and Vision Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs and company match of charitable contributions Family Planning Support Flexible Work Paths Tuition reimbursement More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Base Salary Range: $130,200 $186,000, based on candidate professional experience level. Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off. The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience. In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
02/08/2023
Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: The Systems Biology Scientist II will be part of a team focused on bioinformatics and computational biology support of translational pre-clinical data analysis in neuroscience therapeutic area. The scientist will apply expertise in bioinformatics, genomics and computational biology to integrate and analyze publicly available and proprietary molecular profiling 'omics datasets and phenotypic data to support Takeda translational preclinical projects. Generate data insights to drive neuroscience projects, interface with research teams and support the data analysis and interpretation needs of neuroscience projects Drive collaborations with internal groups, external partners, including CROs and academia for data analysis and machine learning. Join Takeda as a Scientist II in our Systems Biology team, based in Cambridge, MA. How you will contribute: ACCOUNTABILITIES Performs advanced analysis of DNA-seq, RNA-seq, ChIP-seq and other sequencing data in combination with publicly available genomics data to extract novel and biologically meaningful information. Apply various computational biology methods for translational research, including systems biology, pathway/network analysis, machine learning, GWAS, TWAS, PGS, etc. Method development for translational research, e.g. predictive modeling for patient stratification and disease indication selection. Integrates genetics, transcriptomics, epigenetics, proteomics and literature data to strengthen understanding of diseases and treatment perturbations. Utilizes multiple approaches for analyses of genetic variation, pathways and networks. Interpret preclinical datasets using appropriate statistical methods. Create visualizations, interpret high dimensional data and explain results to cross-functional teams. Apply machine learning algorithms to large-scale datasets Schedule and execute tasks to meet deadlines. Maintain and share code. Writes study reports and presents data effectively in all settings and with participants of all levels of the organization. DIMENSIONS AND ASPECTS Demonstrates in-depth knowledge of currently assigned research methods Understands the basics of oligonucleotide synthesis Demonstrates basic knowledge of science/technology outside specific discipline Recognizes problems and considers the significance of irregularities Technical/Functional (Line) Expertise Solid background in genetics and genomics with an understanding of neurodevelopmental and/or neurodegerative disorders, and ability to interpret genetic and genomics findings in disease context. Solid hands on experience with GWAS/PheWAS/eQTL/pQTL analyses, WES/WGS sequencing data analyses, and rare variants analyses required. Experience in using pathway-based approaches, multivariate analyses, polygenic risk score analyses, machine learning Hands on experience in using public human databases Be expert in sequencing data analysis such as RNAseq, DNAseq, scRNA-seq, etc. Keeps current with emerging trends in bioinformatics and computational biology. Independently keep abreast of current literature in computational biology for drug discovery and development. Solid knowledge of Unix, command lines interfaces, and fluency in common scripting and/or programming language (e.g. R, Python, Perl, Java, C/C++) used for bioinformatics analysis. Familiarity with parallel computing, relational databases (e.g., SQL) and cloud computing or distributed computing (i.e. AWS). Familiarity with popular public domain data sources and programmatic interfaces Excellent problem solving, communication, presentation, and interpersonal skills; able to provide input on timelines and resource needs as indicated Independent, self-starting and supportive of team-based research and able to work effectively in a matrix organization Background in/experience with Neuroscience is a plus Minimum Requirements/Qualifications: PhD in bioinformatics, computational biology, or a related field with 2+ years of postdoctoral or industry experience, or MS with 8+ years' experience, or BS with 10+ years' experience Previous industry experience, preferably with big pharmaceutical companies and on clinical programs. What Takeda can offer you: Comprehensive Healthcare: Medical, Dental, and Vision Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs and company match of charitable contributions Family Planning Support Flexible Work Paths Tuition reimbursement More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Base Salary Range: $130,200 $186,000, based on candidate professional experience level. Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off. The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience. In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
CaptiveAire (CAS) is the nation's leading manufacturer of commercial kitchen ventilation systems, and now provides a complete solution of fans, heaters, ductwork, and HVAC equipment. For over 40 years, we've led the industry with innovative technologies, unmatched service, competitive pricing, and rapid lead times. CaptiveAire maintains a network of over 90 sales offices in the U.S. and Canada and six strategically located manufacturing plants in North Carolina, Iowa, Oklahoma, California, Pennsylvania and Florida. Position Summary: Seeking a driven and motivated sales engineer to join our sales team, focusing on growing our newest product line - the Paragon DOAS as well as other products. This position will involve applications engineering, outside sales and field service work. Sales Engineers should be comfortable working in a results driven, fast-paced environment. Primary Job Responsibilities: Develop CaptiveAire into more than just the "hood" and kitchen ventilation company through educating customers and selling our Paragon DOAS unit focusing on major markets. Provide integrated application engineering and design support for a wide range of ventilation applications with the goal of providing sustainable products and the latest technologies best designed to meet the customers' needs. Work directly with Reps Responsibilities will vary and may include presentations, quotes, submittals, technical product support, job site visits and hands on troubleshooting as needed. Educate and promote CAS products to users in your market. This includes conference calls, meetings, presentations, and product demo's. Research and develop new business opportunities with new and existing users Top notch customer service and willingness to go above and beyond to serve the customer. Quick turnaround times a priority Required skills: 2-5 yrs experience in HVAC industry, sales experience preferred but not required - Salary based upon experience MEP or other engineering experience strongly preferred 4 year technical degree in a mechanical, electrical, construction or physics oriented curriculum Excellent computer, organizational and communication/presentation skills; Strong desire to interface with the customer Embrace new technologies and business savvy Passion for work with aggressive nature to succeed Willing to travel for various training opportunities MUST BE A "GO GETTER"! Benefits: Medical, dental and vision insurance Disability & life insurance based upon election of medical insurance Paid holidays, vacation, and sick days based upon tenure 401k with employer match Flexible spending account (FSA) Salary: Competitive base salary with monthly bonus based on productivity and profits. Captive-Aire Systems, Inc. is proud to be an equal opportunity workplace. We review applications for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, ancestry, citizenship, age, uniformed services, genetic information, physical or mental disability, medical condition, marital status, or any other basis prohibited by law. To qualify, applicants must be legally authorized to work in the United States. At this time we are not able to consider applicants that require sponsorship, now or in the future, for employment visa status.
02/08/2023
Full time
CaptiveAire (CAS) is the nation's leading manufacturer of commercial kitchen ventilation systems, and now provides a complete solution of fans, heaters, ductwork, and HVAC equipment. For over 40 years, we've led the industry with innovative technologies, unmatched service, competitive pricing, and rapid lead times. CaptiveAire maintains a network of over 90 sales offices in the U.S. and Canada and six strategically located manufacturing plants in North Carolina, Iowa, Oklahoma, California, Pennsylvania and Florida. Position Summary: Seeking a driven and motivated sales engineer to join our sales team, focusing on growing our newest product line - the Paragon DOAS as well as other products. This position will involve applications engineering, outside sales and field service work. Sales Engineers should be comfortable working in a results driven, fast-paced environment. Primary Job Responsibilities: Develop CaptiveAire into more than just the "hood" and kitchen ventilation company through educating customers and selling our Paragon DOAS unit focusing on major markets. Provide integrated application engineering and design support for a wide range of ventilation applications with the goal of providing sustainable products and the latest technologies best designed to meet the customers' needs. Work directly with Reps Responsibilities will vary and may include presentations, quotes, submittals, technical product support, job site visits and hands on troubleshooting as needed. Educate and promote CAS products to users in your market. This includes conference calls, meetings, presentations, and product demo's. Research and develop new business opportunities with new and existing users Top notch customer service and willingness to go above and beyond to serve the customer. Quick turnaround times a priority Required skills: 2-5 yrs experience in HVAC industry, sales experience preferred but not required - Salary based upon experience MEP or other engineering experience strongly preferred 4 year technical degree in a mechanical, electrical, construction or physics oriented curriculum Excellent computer, organizational and communication/presentation skills; Strong desire to interface with the customer Embrace new technologies and business savvy Passion for work with aggressive nature to succeed Willing to travel for various training opportunities MUST BE A "GO GETTER"! Benefits: Medical, dental and vision insurance Disability & life insurance based upon election of medical insurance Paid holidays, vacation, and sick days based upon tenure 401k with employer match Flexible spending account (FSA) Salary: Competitive base salary with monthly bonus based on productivity and profits. Captive-Aire Systems, Inc. is proud to be an equal opportunity workplace. We review applications for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, ancestry, citizenship, age, uniformed services, genetic information, physical or mental disability, medical condition, marital status, or any other basis prohibited by law. To qualify, applicants must be legally authorized to work in the United States. At this time we are not able to consider applicants that require sponsorship, now or in the future, for employment visa status.
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director, Molecular Analytics, Cell Therapies Analytical Development where you will will join a dynamic team of scientists whose main mission is analytical method development to support cell therapy projects in all phases of clinical development. You bring in deep knowledge on molecular technology applicable to CMC and be responsible for product control strategies through life cycle management of cell therapy products. As part of the Oncology Cell Therapy and Therapeutic Area Unit (OTAU) team, you will report to the Head of Viral Vector and Cell Bank Analytics, Cell Therapy. How you will contribute: Our team is looking for an Associate Director to lead our Analytical Development efforts for Cell Therapy products. You will join a dynamic team of scientists whose main mission is analytical method development to support cell therapy projects in all phases of clinical development. You will have a strong background in molecular biology and method development, experience developing molecular assays in a regulated environment, familiarity with analytical method transfers to CROs, as well as strong team management and interpersonal skills. You will bring in deep knowledge on molecular technology applicable to CMC and be responsible for product control strategies through life cycle management of cell therapy products. Lead the development of molecular assays (e.g. PCR, cell-based assays with molecular readout, sequencing, NGS, etc) used for release and characterization of viral vectors, cell banks and drug products. Lead a team that investigates and implements new technologies and QC friendly molecular platforms within Cell Therapy CMC strategies to enable and deliver IND and BLA filings. You will be responsible for the successful transfer of early phase analytics from biotech and academic partners or internal programs across global Takeda sites. You will mentor and develop staff at all levels in the organization. Ensure timely completion and delivery of analytical results and documentation (eLN, reports, SOPs, etc.) to support product development during clinical phases. You will be responsible for establishing operating budgets and managing expenses within those budgets Minimum Requirements/Qualifications: PhD in life science or engineering (such as Biotechnology, Immunology, Molecular Biology, Biochemistry, Bioinformatics) and at least 7 years of relevant industry experience, or a Master's with at least 10 of relevant industry experience or Bachelor's degree in a life science and at least 12 years of relevant industry experience. Understanding of various cell and gene therapies, gene editing technologies with previous experience in CAR T or CAR NK products is a big plus. Extensive experience in lead analytical activities to support IND, Phase I/II, pivotal and commercialization in the biotech and pharmaceutical industry Experiences with genomic & molecular methods e.g. PCR (qPCR & ddPCR), NGS, bioassays for impurity assessment and characterization, critical material assessment and ID test development, comparability studies are required. Proven track record and demonstrated deep understanding of pharmaceutical drug development, program development and cross-functional engagement Preferred Qualifications: Self-motivated and comfortable working independently in a fast-paced environment. Demonstrated ability to work in a matrixed environment and interact productively with associates, scientists, and management at various levels, both locally and internationally. Experience working in a regulated environment. Excellent written and verbal communication skills. What Takeda can offer you: Comprehensive Healthcare: Medical, Dental, and Vision Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs and company match of charitable contributions Family Planning Support Flexible Work Paths Tuition reimbursement More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
02/08/2023
Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director, Molecular Analytics, Cell Therapies Analytical Development where you will will join a dynamic team of scientists whose main mission is analytical method development to support cell therapy projects in all phases of clinical development. You bring in deep knowledge on molecular technology applicable to CMC and be responsible for product control strategies through life cycle management of cell therapy products. As part of the Oncology Cell Therapy and Therapeutic Area Unit (OTAU) team, you will report to the Head of Viral Vector and Cell Bank Analytics, Cell Therapy. How you will contribute: Our team is looking for an Associate Director to lead our Analytical Development efforts for Cell Therapy products. You will join a dynamic team of scientists whose main mission is analytical method development to support cell therapy projects in all phases of clinical development. You will have a strong background in molecular biology and method development, experience developing molecular assays in a regulated environment, familiarity with analytical method transfers to CROs, as well as strong team management and interpersonal skills. You will bring in deep knowledge on molecular technology applicable to CMC and be responsible for product control strategies through life cycle management of cell therapy products. Lead the development of molecular assays (e.g. PCR, cell-based assays with molecular readout, sequencing, NGS, etc) used for release and characterization of viral vectors, cell banks and drug products. Lead a team that investigates and implements new technologies and QC friendly molecular platforms within Cell Therapy CMC strategies to enable and deliver IND and BLA filings. You will be responsible for the successful transfer of early phase analytics from biotech and academic partners or internal programs across global Takeda sites. You will mentor and develop staff at all levels in the organization. Ensure timely completion and delivery of analytical results and documentation (eLN, reports, SOPs, etc.) to support product development during clinical phases. You will be responsible for establishing operating budgets and managing expenses within those budgets Minimum Requirements/Qualifications: PhD in life science or engineering (such as Biotechnology, Immunology, Molecular Biology, Biochemistry, Bioinformatics) and at least 7 years of relevant industry experience, or a Master's with at least 10 of relevant industry experience or Bachelor's degree in a life science and at least 12 years of relevant industry experience. Understanding of various cell and gene therapies, gene editing technologies with previous experience in CAR T or CAR NK products is a big plus. Extensive experience in lead analytical activities to support IND, Phase I/II, pivotal and commercialization in the biotech and pharmaceutical industry Experiences with genomic & molecular methods e.g. PCR (qPCR & ddPCR), NGS, bioassays for impurity assessment and characterization, critical material assessment and ID test development, comparability studies are required. Proven track record and demonstrated deep understanding of pharmaceutical drug development, program development and cross-functional engagement Preferred Qualifications: Self-motivated and comfortable working independently in a fast-paced environment. Demonstrated ability to work in a matrixed environment and interact productively with associates, scientists, and management at various levels, both locally and internationally. Experience working in a regulated environment. Excellent written and verbal communication skills. What Takeda can offer you: Comprehensive Healthcare: Medical, Dental, and Vision Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs and company match of charitable contributions Family Planning Support Flexible Work Paths Tuition reimbursement More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
Overview: Job title Customer Care Associate- Work Part time until you graduate, then become Full Time! Job description Overview:Who are we? Plymouth Rock is a leading auto and home insurance provider serving customers across Connecticut, Massachusetts, New Jersey, New Hampshire, New York and Pennsylvania. Headquarters is in Boston right across the street from South Station. What you'll be Doing: In this position, the Customer Service Representative will be a highly motivated individual responsible for delivering superior service experiences to our independent agents and policyholders by phone and email. Responsibilities: Primarily responsible to provide extraordinary service to our policy holders and agents by phone and email Research customer concerns and take accountability through resolution. Escalate customer complaints and feedback to management as required. Process policy endorsements accurately and within a timely fashion in accordance with established company procedures. Provide training to our independent agency force in support of our products and services. Complete all assigned project work qualitatively and in a timely manner. Knowledge, Skills, and Abilities Required: Excellent oral and written communications skills. Sound problem resolution and analytical skills. Excellent organizational skills and the ability to work in a fast past environment. Sound knowledge of Microsoft Office. Employees will be working 10-18 hours a week between Monday-Saturday. Education & Experience: A Bachelor's degree or enrolled in a degree program Minimum of 1 year of overall work experience.
02/08/2023
Full time
Overview: Job title Customer Care Associate- Work Part time until you graduate, then become Full Time! Job description Overview:Who are we? Plymouth Rock is a leading auto and home insurance provider serving customers across Connecticut, Massachusetts, New Jersey, New Hampshire, New York and Pennsylvania. Headquarters is in Boston right across the street from South Station. What you'll be Doing: In this position, the Customer Service Representative will be a highly motivated individual responsible for delivering superior service experiences to our independent agents and policyholders by phone and email. Responsibilities: Primarily responsible to provide extraordinary service to our policy holders and agents by phone and email Research customer concerns and take accountability through resolution. Escalate customer complaints and feedback to management as required. Process policy endorsements accurately and within a timely fashion in accordance with established company procedures. Provide training to our independent agency force in support of our products and services. Complete all assigned project work qualitatively and in a timely manner. Knowledge, Skills, and Abilities Required: Excellent oral and written communications skills. Sound problem resolution and analytical skills. Excellent organizational skills and the ability to work in a fast past environment. Sound knowledge of Microsoft Office. Employees will be working 10-18 hours a week between Monday-Saturday. Education & Experience: A Bachelor's degree or enrolled in a degree program Minimum of 1 year of overall work experience.
Who We Are Boston Consulting Group partners with leaders in business and society to tackle their most important challenges and capture their greatest opportunities. BCG was the pioneer in business strategy when it was founded in 1963. Today, we work closely with clients to embrace a transformational approach aimed at benefiting all stakeholders-empowering organizations to grow, build sustainable competitive advantage, and drive positive societal impact. Our diverse, global teams bring deep industry and functional expertise and a range of perspectives that question the status quo and spark change. BCG delivers solutions through leading-edge management consulting, technology and design, and corporate and digital ventures. We work in a uniquely collaborative model across the firm and throughout all levels of the client organization, fueled by the goal of helping our clients thrive and enabling them to make the world a better place. Practice Area Profile Through People & Organization, BCG works with our clients - senior business executives- who value BCG's strategic, fact-based, and impact-oriented approach supported by senior teams, rich benchmarking databases and analytical capabilities. We provide expertise to our clients across all industries through our capabilities in areas like Organization Design; Change Management; Shared Services and Support Functions; Culture, Purpose and Engagement; Leadership & Talent; and Agile Ways of Working. What You'll Do BCG's purpose is to "Unlock the Potential of Those Who Advance the World". At BCG U, we contribute to that unlock through next generation, large-scale learning solutions that build an organization's capability to transform in a transforming world. Our focus is on ensuring leaders and teams at every level have the knowledge and skills they need to play their pivotal role in realizing value and impact. BCG is looking to fill several senior Learning Architect roles on the BCG U team to help us engineer impactful capability building into large-scale transformations. You will be joining a global team of people and organization experts passionate about this topic to help build and deploy the cutting-edge learning solutions and to advise on the learning infrastructure required to unleash the power of talent in organizations that are on ambitious journeys to transform. As a Learning Architect you will partner closely with clients to assess learning ecosystem maturity, shape talent development strategies, design and implement innovative capability building solutions, and reinforce learning as a key lever to accelerate the delivery of target business outcomes that capture transformation value. You will play a leading role in the shaping, building and commercializing of BCG U's go-to-market offers and resources in capability building, including immersive programs in transformational topics (e.g., Digital, Agile, Change, Sustainability) that incorporate best-practice learning design approaches, cutting-edge education technology solutions and performance support tools, and the discipline of measuring meaningful outcomes from learning interventions. You will play a leadership role in defining and implementing the next frontier for corporate learning, and in mobilizing our diverse BCG U team toward that objective. Our Expert Consulting Track (ECT) The Expert Consulting Track (ECT) is vital to BCG's ability to successfully meet our clients' demand for deep expertise and advanced technical capabilities. Experts deliver next-level impact for BCG's most complex and cutting-edge client challenges. Experts focus on developing BCG's thought leadership, commercial capabilities, and intellectual property assets; and their work is essential to our delivery model. Working as part of a multidisciplinary team to bring the 'best of BCG' to our clients, Experts come from diverse backgrounds, with expertise often gained outside of BCG in industry, academia, or specialized consulting. What You'll Bring (Experience & Qualifications) 7-15 years of work experience; experience in top level advisory or consulting environment preferred Track record in building and implementing end-to-end talent development programs for large organizations in private and public sectors Evidence of breaking the "status quo" in corporate learning, implementing innovative, immersive and scalable solutions that drive tangible business impact Experience in building key elements of the required infrastructure supporting capability building programs in large organizations (e.g. lead role in a Corporate University or Learning Innovation unit, learning tech stack implementation, creating a high-quality delivery cadre, etc.) A track record of building, growing and leading multi-disciplinary teams Entrepreneurial spirit and initiative Passion for using learning to drive outcomes PREFERRED SKILLS Strategic vision for corporate learning and development Ability to design end-to-end talent development solutions Strong leadership and interpersonal skills Tenacity and growth mindset WHO YOU'LL WORK WITH: You will join our People and Organization practice and be part of our global people and organization community of experts. Day-to-day you will collaborate with different Clients and BCG project teams, as well as Topic and Practice area stakeholders across BCG. YOU'LL BE BASED IN: Dallas or Boston locations preferred but will also consider candidates in New York, Atlanta, or Chicago. YOU'LL BE TRAVELING: Travel is anticipated and estimated at 20-40% in order to engage with teams and clients on an as needed basis. VACCINE: Candidates should be aware that BCG currently maintains a policy requiring all US & Canada based employees to be fully vaccinated against COVID-19. Newly hired employees must be fully vaccinated prior to their employment start date. BCG is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated for medical or religious reasons where it is not an undue hardship to the company to do so as provided under applicable federal, state, provincial and local law. FOR U.S. APPLICANTS: Boston Consulting Company ("BCG") is an Equal Opportunity/Affirmative Action employer. All qualified applicants will be considered for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by applicable law. The first year base compensation for this role is: Consultant: $190,000 USD Project Leader: $225,400 USD Associate Director: $252,900 USD Partner and Associate Director: $287,000 USD In addition to your base salary, you will also be eligible for an annual discretionary performance bonus and BCG's Profit Sharing and Retirement Fund (PSRF) contribution. BCG also provides a market leading benefits package described below. At BCG, we are committed to offering a comprehensive benefit program that includes everything our employees and their families need to be well and live life to the fullest. We pay the full cost of medical, dental, and vision coverage for employees - and their eligible family members. That's zero dollars in premiums taken from employee paychecks. All our plans provide best in class coverage: Zero dollar ($0) health insurance premiums for BCG employees, spouses, and children Low $5 (USD) copays for trips to the doctor, urgent care visits and prescriptions for generic drugs Dental coverage, including up to $5,000 (USD) in orthodontia benefits Vision insurance with coverage for both glasses and contact lenses annually Reimbursement for gym memberships and other fitness activities Fully vested retirement contributions made annually, whether you contribute or not Generous paid time off including vacation, holidays, and annual office closure between Christmas and New Years Paid Parental Leave and other family benefits such as elective egg freezing, surrogacy, and adoption reimbursement Employees, spouses, and children are covered at no cost. Employees share in the cost of domestic partner coverage.
02/08/2023
Full time
Who We Are Boston Consulting Group partners with leaders in business and society to tackle their most important challenges and capture their greatest opportunities. BCG was the pioneer in business strategy when it was founded in 1963. Today, we work closely with clients to embrace a transformational approach aimed at benefiting all stakeholders-empowering organizations to grow, build sustainable competitive advantage, and drive positive societal impact. Our diverse, global teams bring deep industry and functional expertise and a range of perspectives that question the status quo and spark change. BCG delivers solutions through leading-edge management consulting, technology and design, and corporate and digital ventures. We work in a uniquely collaborative model across the firm and throughout all levels of the client organization, fueled by the goal of helping our clients thrive and enabling them to make the world a better place. Practice Area Profile Through People & Organization, BCG works with our clients - senior business executives- who value BCG's strategic, fact-based, and impact-oriented approach supported by senior teams, rich benchmarking databases and analytical capabilities. We provide expertise to our clients across all industries through our capabilities in areas like Organization Design; Change Management; Shared Services and Support Functions; Culture, Purpose and Engagement; Leadership & Talent; and Agile Ways of Working. What You'll Do BCG's purpose is to "Unlock the Potential of Those Who Advance the World". At BCG U, we contribute to that unlock through next generation, large-scale learning solutions that build an organization's capability to transform in a transforming world. Our focus is on ensuring leaders and teams at every level have the knowledge and skills they need to play their pivotal role in realizing value and impact. BCG is looking to fill several senior Learning Architect roles on the BCG U team to help us engineer impactful capability building into large-scale transformations. You will be joining a global team of people and organization experts passionate about this topic to help build and deploy the cutting-edge learning solutions and to advise on the learning infrastructure required to unleash the power of talent in organizations that are on ambitious journeys to transform. As a Learning Architect you will partner closely with clients to assess learning ecosystem maturity, shape talent development strategies, design and implement innovative capability building solutions, and reinforce learning as a key lever to accelerate the delivery of target business outcomes that capture transformation value. You will play a leading role in the shaping, building and commercializing of BCG U's go-to-market offers and resources in capability building, including immersive programs in transformational topics (e.g., Digital, Agile, Change, Sustainability) that incorporate best-practice learning design approaches, cutting-edge education technology solutions and performance support tools, and the discipline of measuring meaningful outcomes from learning interventions. You will play a leadership role in defining and implementing the next frontier for corporate learning, and in mobilizing our diverse BCG U team toward that objective. Our Expert Consulting Track (ECT) The Expert Consulting Track (ECT) is vital to BCG's ability to successfully meet our clients' demand for deep expertise and advanced technical capabilities. Experts deliver next-level impact for BCG's most complex and cutting-edge client challenges. Experts focus on developing BCG's thought leadership, commercial capabilities, and intellectual property assets; and their work is essential to our delivery model. Working as part of a multidisciplinary team to bring the 'best of BCG' to our clients, Experts come from diverse backgrounds, with expertise often gained outside of BCG in industry, academia, or specialized consulting. What You'll Bring (Experience & Qualifications) 7-15 years of work experience; experience in top level advisory or consulting environment preferred Track record in building and implementing end-to-end talent development programs for large organizations in private and public sectors Evidence of breaking the "status quo" in corporate learning, implementing innovative, immersive and scalable solutions that drive tangible business impact Experience in building key elements of the required infrastructure supporting capability building programs in large organizations (e.g. lead role in a Corporate University or Learning Innovation unit, learning tech stack implementation, creating a high-quality delivery cadre, etc.) A track record of building, growing and leading multi-disciplinary teams Entrepreneurial spirit and initiative Passion for using learning to drive outcomes PREFERRED SKILLS Strategic vision for corporate learning and development Ability to design end-to-end talent development solutions Strong leadership and interpersonal skills Tenacity and growth mindset WHO YOU'LL WORK WITH: You will join our People and Organization practice and be part of our global people and organization community of experts. Day-to-day you will collaborate with different Clients and BCG project teams, as well as Topic and Practice area stakeholders across BCG. YOU'LL BE BASED IN: Dallas or Boston locations preferred but will also consider candidates in New York, Atlanta, or Chicago. YOU'LL BE TRAVELING: Travel is anticipated and estimated at 20-40% in order to engage with teams and clients on an as needed basis. VACCINE: Candidates should be aware that BCG currently maintains a policy requiring all US & Canada based employees to be fully vaccinated against COVID-19. Newly hired employees must be fully vaccinated prior to their employment start date. BCG is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated for medical or religious reasons where it is not an undue hardship to the company to do so as provided under applicable federal, state, provincial and local law. FOR U.S. APPLICANTS: Boston Consulting Company ("BCG") is an Equal Opportunity/Affirmative Action employer. All qualified applicants will be considered for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by applicable law. The first year base compensation for this role is: Consultant: $190,000 USD Project Leader: $225,400 USD Associate Director: $252,900 USD Partner and Associate Director: $287,000 USD In addition to your base salary, you will also be eligible for an annual discretionary performance bonus and BCG's Profit Sharing and Retirement Fund (PSRF) contribution. BCG also provides a market leading benefits package described below. At BCG, we are committed to offering a comprehensive benefit program that includes everything our employees and their families need to be well and live life to the fullest. We pay the full cost of medical, dental, and vision coverage for employees - and their eligible family members. That's zero dollars in premiums taken from employee paychecks. All our plans provide best in class coverage: Zero dollar ($0) health insurance premiums for BCG employees, spouses, and children Low $5 (USD) copays for trips to the doctor, urgent care visits and prescriptions for generic drugs Dental coverage, including up to $5,000 (USD) in orthodontia benefits Vision insurance with coverage for both glasses and contact lenses annually Reimbursement for gym memberships and other fitness activities Fully vested retirement contributions made annually, whether you contribute or not Generous paid time off including vacation, holidays, and annual office closure between Christmas and New Years Paid Parental Leave and other family benefits such as elective egg freezing, surrogacy, and adoption reimbursement Employees, spouses, and children are covered at no cost. Employees share in the cost of domestic partner coverage.
By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director, Global Regulatory Affairs CMC where you will be responsible and accountable for Regulatory CMC development, registration and post-approval strategies. You will communicate and negotiate with international Health Authorities, directly and indirectly. You will ensure global strategies are accomplished across both new product development and existing portfolio life cycle management. As part of the Global Regulatory Affairs CMC team, you will work with Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle. How you will contribute: Independently manage regulatory submissions for assigned compounds in several phases of clinical development, global marketing applications, and post-approval life cycle activities. Member of global teams which require experienced interpretation of applicable EMA/FDA/ICH/WHO/Global regulations to ensure CMC compliance. Recommend direction for essential operations and new programs in collaboration with local and global team members. Lead team members that establish CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirement. Develop staff, if required, including staff professional development and project oversight. Represent Takeda Regulatory Affairs CMC in Health Authority meetings and lead preparation activities for meetings with Health Authorities on CMC related matters. Interact directly with international Health Authorities. Participate in and facilitate agency meetings. Ensure project team colleagues, line management, and partners are informed of developments that may affect regulatory success. Provide solutions to prevent recurrence of issues. Stay up-to-date with current and evolving regulatory CMC requirements, apply this knowledge to assigned projects, and shares experience with others to support their development. Maintain constructive relations with essential colleagues, eg colleagues within Takeda, Alliance Partners, and Health Authority representatives. Evaluate new business development opportunities or participate on due diligence teams. Evaluate change proposals for global regulatory impact and plan global variations and amendments. Minimum Requirements/Qualifications: BS/BA Degree in a Scientific Discipline, Advanced Degree preferred. 8+ years pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead, or equivalent industry experience (eg, Pharmaceutical Development, Analytical Development, Production, Quality Assurance). Experience with pharmaceutical development of active pharmaceutical ingredient/drug substances or drug products, analytical characterization, process scale-up or regulatory registration of products is required. Experience with global regulatory aspects of CMC involving undefined frameworks with medium technical complexity and defined scope. Experience liaising with Regulatory Agencies having served as lead in successful Agency Interactions related to CMC submissions and product development meetings, international experience preferred. Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. Experience providing strategic regulatory guidance to drug development, registration, and post-market support teams. Provide regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance. Demonstrate leadership, problem-solving ability, flexibility and values teamwork. Demonstrated ability to work well within a Matrix structure in a complex environment. Exercise good judgement in elevating and communicating actual or potential issues to line management and presents solutions to those issues. Excellent written and oral communication skills required. Active participation in Agency/Industry groups/forums preferred. What Takeda can offer you: Comprehensive Healthcare: Medical, Dental, and Vision Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs and company match of charitable contributions Family Planning Support Flexible Work Paths Tuition reimbursement More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as hybrid in accordance with Takeda's Hybrid and Remote Work policy. Base Salary Range: $137,200 to $196,000, based on candidate professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off. This posting is made in compliance with Colorado's Equal Pay for Equal Work Act, C.R.S. § 8-5-101 et seq The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience. In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply. Empowering our people to shine: Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MALexington, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
02/08/2023
Full time
By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director, Global Regulatory Affairs CMC where you will be responsible and accountable for Regulatory CMC development, registration and post-approval strategies. You will communicate and negotiate with international Health Authorities, directly and indirectly. You will ensure global strategies are accomplished across both new product development and existing portfolio life cycle management. As part of the Global Regulatory Affairs CMC team, you will work with Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle. How you will contribute: Independently manage regulatory submissions for assigned compounds in several phases of clinical development, global marketing applications, and post-approval life cycle activities. Member of global teams which require experienced interpretation of applicable EMA/FDA/ICH/WHO/Global regulations to ensure CMC compliance. Recommend direction for essential operations and new programs in collaboration with local and global team members. Lead team members that establish CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirement. Develop staff, if required, including staff professional development and project oversight. Represent Takeda Regulatory Affairs CMC in Health Authority meetings and lead preparation activities for meetings with Health Authorities on CMC related matters. Interact directly with international Health Authorities. Participate in and facilitate agency meetings. Ensure project team colleagues, line management, and partners are informed of developments that may affect regulatory success. Provide solutions to prevent recurrence of issues. Stay up-to-date with current and evolving regulatory CMC requirements, apply this knowledge to assigned projects, and shares experience with others to support their development. Maintain constructive relations with essential colleagues, eg colleagues within Takeda, Alliance Partners, and Health Authority representatives. Evaluate new business development opportunities or participate on due diligence teams. Evaluate change proposals for global regulatory impact and plan global variations and amendments. Minimum Requirements/Qualifications: BS/BA Degree in a Scientific Discipline, Advanced Degree preferred. 8+ years pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead, or equivalent industry experience (eg, Pharmaceutical Development, Analytical Development, Production, Quality Assurance). Experience with pharmaceutical development of active pharmaceutical ingredient/drug substances or drug products, analytical characterization, process scale-up or regulatory registration of products is required. Experience with global regulatory aspects of CMC involving undefined frameworks with medium technical complexity and defined scope. Experience liaising with Regulatory Agencies having served as lead in successful Agency Interactions related to CMC submissions and product development meetings, international experience preferred. Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. Experience providing strategic regulatory guidance to drug development, registration, and post-market support teams. Provide regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance. Demonstrate leadership, problem-solving ability, flexibility and values teamwork. Demonstrated ability to work well within a Matrix structure in a complex environment. Exercise good judgement in elevating and communicating actual or potential issues to line management and presents solutions to those issues. Excellent written and oral communication skills required. Active participation in Agency/Industry groups/forums preferred. What Takeda can offer you: Comprehensive Healthcare: Medical, Dental, and Vision Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs and company match of charitable contributions Family Planning Support Flexible Work Paths Tuition reimbursement More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as hybrid in accordance with Takeda's Hybrid and Remote Work policy. Base Salary Range: $137,200 to $196,000, based on candidate professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off. This posting is made in compliance with Colorado's Equal Pay for Equal Work Act, C.R.S. § 8-5-101 et seq The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience. In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply. Empowering our people to shine: Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MALexington, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director, Global Regulatory Affairs CMC where you will be responsible and accountable for Regulatory CMC development, registration and post-approval strategies. You will communicate and negotiate with international Health Authorities, directly and indirectly. You will ensure global strategies are accomplished across both new product development and existing portfolio life cycle management. As part of the Global Regulatory Affairs CMC team, you will work with Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle. How you will contribute: Independently manage regulatory submissions for assigned compounds in several phases of clinical development, global marketing applications, and post-approval life cycle activities. Member of global teams which require experienced interpretation of applicable EMA/FDA/ICH/WHO/Global regulations to ensure CMC compliance. Recommend direction for essential operations and new programs in collaboration with local and global team members. Lead team members that establish CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirement. Develop staff, if required, including staff professional development and project oversight. Represent Takeda Regulatory Affairs CMC in Health Authority meetings and lead preparation activities for meetings with Health Authorities on CMC related matters. Interact directly with international Health Authorities. Participate in and facilitate agency meetings. Ensure project team colleagues, line management, and partners are informed of developments that may affect regulatory success. Provide solutions to prevent recurrence of issues. Stay up-to-date with current and evolving regulatory CMC requirements, apply this knowledge to assigned projects, and shares experience with others to support their development. Maintain constructive relations with essential colleagues, eg colleagues within Takeda, Alliance Partners, and Health Authority representatives. Evaluate new business development opportunities or participate on due diligence teams. Evaluate change proposals for global regulatory impact and plan global variations and amendments. Minimum Requirements/Qualifications: BS/BA Degree in a Scientific Discipline, Advanced Degree preferred. 8+ years pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead, or equivalent industry experience (eg, Pharmaceutical Development, Analytical Development, Production, Quality Assurance). Experience with pharmaceutical development of active pharmaceutical ingredient/drug substances or drug products, analytical characterization, process scale-up or regulatory registration of products is required. Experience with global regulatory aspects of CMC involving undefined frameworks with medium technical complexity and defined scope. Experience liaising with Regulatory Agencies having served as lead in successful Agency Interactions related to CMC submissions and product development meetings, international experience preferred. Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. Experience providing strategic regulatory guidance to drug development, registration, and post-market support teams. Provide regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance. Demonstrate leadership, problem-solving ability, flexibility and values teamwork. Demonstrated ability to work well within a Matrix structure in a complex environment. Exercise good judgement in elevating and communicating actual or potential issues to line management and presents solutions to those issues. Excellent written and oral communication skills required. Active participation in Agency/Industry groups/forums preferred. What Takeda can offer you: Comprehensive Healthcare: Medical, Dental, and Vision Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs and company match of charitable contributions Family Planning Support Flexible Work Paths Tuition reimbursement More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as hybrid in accordance with Takeda's Hybrid and Remote Work policy. Base Salary Range: $137,200 to $196,000, based on candidate professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off. This posting is made in compliance with Colorado's Equal Pay for Equal Work Act, C.R.S. § 8-5-101 et seq The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience. In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply. Empowering our people to shine: Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MALexington, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
02/08/2023
Full time
By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director, Global Regulatory Affairs CMC where you will be responsible and accountable for Regulatory CMC development, registration and post-approval strategies. You will communicate and negotiate with international Health Authorities, directly and indirectly. You will ensure global strategies are accomplished across both new product development and existing portfolio life cycle management. As part of the Global Regulatory Affairs CMC team, you will work with Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle. How you will contribute: Independently manage regulatory submissions for assigned compounds in several phases of clinical development, global marketing applications, and post-approval life cycle activities. Member of global teams which require experienced interpretation of applicable EMA/FDA/ICH/WHO/Global regulations to ensure CMC compliance. Recommend direction for essential operations and new programs in collaboration with local and global team members. Lead team members that establish CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirement. Develop staff, if required, including staff professional development and project oversight. Represent Takeda Regulatory Affairs CMC in Health Authority meetings and lead preparation activities for meetings with Health Authorities on CMC related matters. Interact directly with international Health Authorities. Participate in and facilitate agency meetings. Ensure project team colleagues, line management, and partners are informed of developments that may affect regulatory success. Provide solutions to prevent recurrence of issues. Stay up-to-date with current and evolving regulatory CMC requirements, apply this knowledge to assigned projects, and shares experience with others to support their development. Maintain constructive relations with essential colleagues, eg colleagues within Takeda, Alliance Partners, and Health Authority representatives. Evaluate new business development opportunities or participate on due diligence teams. Evaluate change proposals for global regulatory impact and plan global variations and amendments. Minimum Requirements/Qualifications: BS/BA Degree in a Scientific Discipline, Advanced Degree preferred. 8+ years pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead, or equivalent industry experience (eg, Pharmaceutical Development, Analytical Development, Production, Quality Assurance). Experience with pharmaceutical development of active pharmaceutical ingredient/drug substances or drug products, analytical characterization, process scale-up or regulatory registration of products is required. Experience with global regulatory aspects of CMC involving undefined frameworks with medium technical complexity and defined scope. Experience liaising with Regulatory Agencies having served as lead in successful Agency Interactions related to CMC submissions and product development meetings, international experience preferred. Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. Experience providing strategic regulatory guidance to drug development, registration, and post-market support teams. Provide regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance. Demonstrate leadership, problem-solving ability, flexibility and values teamwork. Demonstrated ability to work well within a Matrix structure in a complex environment. Exercise good judgement in elevating and communicating actual or potential issues to line management and presents solutions to those issues. Excellent written and oral communication skills required. Active participation in Agency/Industry groups/forums preferred. What Takeda can offer you: Comprehensive Healthcare: Medical, Dental, and Vision Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs and company match of charitable contributions Family Planning Support Flexible Work Paths Tuition reimbursement More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as hybrid in accordance with Takeda's Hybrid and Remote Work policy. Base Salary Range: $137,200 to $196,000, based on candidate professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off. This posting is made in compliance with Colorado's Equal Pay for Equal Work Act, C.R.S. § 8-5-101 et seq The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience. In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply. Empowering our people to shine: Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MALexington, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
When you work for AmeriGas, you become a part of something BIG! Founded in 1959, AmeriGas is the nation's premiere propane company, serving over 1.5 million residential, commercial, industrial and motor fuel propane customers. Together, over 6,500 dedicated professionals will deliver over 1 billion gallons of propane from 1,800+ distribution points across the United States. Job Summary (Purpose): The Staff Accountant - Cost Accounting assists with the creation and analysis of departmental financial projections, cost of gas analysis, SOX/GAAP reporting and compliance, and general ledger activity. In addition, will work with a team to assist 600+ locations with fuel inventory. Key Characteristics: Functions with limited day to day supervision. Ability to meet all deadlines and multi-task. Ability to analyze data and correspond effectively with internal and external customers. Duties and Responsibilities: Train on using the RightAngle system for Cost Accounting needs. Reconcile monthly fuel inventory recaps with documentation from the districts to ensure cost of sales, ending inventory, and gain/loss amounts are properly stated. Provide Operations Management with weekly cost of gas projections. Communicate with districts concerning fuel inventory and receipt of fuel entries in SAP, and follow-up with fuel in-transit items. Prepare account analysis and reconciliation to General Ledger and inventory roll forwards. Prepare journal entries as needed to account for the cost of sales for non-propane activity. Review and reconcile pipeline, storage, exchange and terminal accounts for inventory levels and transfer cost in RightAngle system. Coordinate with Supply and Operations to establish accurate storage, terminal, and tariff rates for storage accounts. Work to improve systems and procedures for timely and meaningful recording and reporting of cost results. Follow up on outstanding, unbilled and fuel in transit to ensure propane is properly accounted for. Knowledge, Skills and Abilities: Strong analytical skills Strong PC skills Proficiency in Excel Excellent communication and follow-up skills. Ability to work in a high volume environment is essential. Knowledge of SAP and PeopleSoft systems preferred. Education and Experience Required: Bachelor's Degree in Accounting or Finance. Cost Accounting Experience helpful 2+ Years of General Accounting/Finance experience preferred AmeriGas is an Equal Opportunity and Affirmative Action Employer. The Company does not discriminate on the basis of race, color, sex, national origin, disability, age, gender identity, sexual orientation, veteran status, or any other legally protected class in its practices. AmeriGas is a Drug Free Workplace. Candidates must be willing to submit to a pre-employment drug screen and a criminal background check. Successful applicants shall be required to pass a pre-employment drug screen as a condition of employment, and if hired, shall be subject to substance abuse testing in accordance with AmeriGas policies. As a federal contractor that engages in safety-sensitive work, AmeriGas cannot permit employees in certain positions to use medical marijuana, even if prescribed by an authorized physician. Similarly, applicants for such positions who are actively using medical marijuana may be denied hire on that basis.
02/08/2023
Full time
When you work for AmeriGas, you become a part of something BIG! Founded in 1959, AmeriGas is the nation's premiere propane company, serving over 1.5 million residential, commercial, industrial and motor fuel propane customers. Together, over 6,500 dedicated professionals will deliver over 1 billion gallons of propane from 1,800+ distribution points across the United States. Job Summary (Purpose): The Staff Accountant - Cost Accounting assists with the creation and analysis of departmental financial projections, cost of gas analysis, SOX/GAAP reporting and compliance, and general ledger activity. In addition, will work with a team to assist 600+ locations with fuel inventory. Key Characteristics: Functions with limited day to day supervision. Ability to meet all deadlines and multi-task. Ability to analyze data and correspond effectively with internal and external customers. Duties and Responsibilities: Train on using the RightAngle system for Cost Accounting needs. Reconcile monthly fuel inventory recaps with documentation from the districts to ensure cost of sales, ending inventory, and gain/loss amounts are properly stated. Provide Operations Management with weekly cost of gas projections. Communicate with districts concerning fuel inventory and receipt of fuel entries in SAP, and follow-up with fuel in-transit items. Prepare account analysis and reconciliation to General Ledger and inventory roll forwards. Prepare journal entries as needed to account for the cost of sales for non-propane activity. Review and reconcile pipeline, storage, exchange and terminal accounts for inventory levels and transfer cost in RightAngle system. Coordinate with Supply and Operations to establish accurate storage, terminal, and tariff rates for storage accounts. Work to improve systems and procedures for timely and meaningful recording and reporting of cost results. Follow up on outstanding, unbilled and fuel in transit to ensure propane is properly accounted for. Knowledge, Skills and Abilities: Strong analytical skills Strong PC skills Proficiency in Excel Excellent communication and follow-up skills. Ability to work in a high volume environment is essential. Knowledge of SAP and PeopleSoft systems preferred. Education and Experience Required: Bachelor's Degree in Accounting or Finance. Cost Accounting Experience helpful 2+ Years of General Accounting/Finance experience preferred AmeriGas is an Equal Opportunity and Affirmative Action Employer. The Company does not discriminate on the basis of race, color, sex, national origin, disability, age, gender identity, sexual orientation, veteran status, or any other legally protected class in its practices. AmeriGas is a Drug Free Workplace. Candidates must be willing to submit to a pre-employment drug screen and a criminal background check. Successful applicants shall be required to pass a pre-employment drug screen as a condition of employment, and if hired, shall be subject to substance abuse testing in accordance with AmeriGas policies. As a federal contractor that engages in safety-sensitive work, AmeriGas cannot permit employees in certain positions to use medical marijuana, even if prescribed by an authorized physician. Similarly, applicants for such positions who are actively using medical marijuana may be denied hire on that basis.
Michael Page is currently hiring for a Construction Project Manager to join one of Boston's most established General Contractors in Boston! Client Details My client has been serving the Greater Boston Construction market for 60+ years, across Healthcare, Life Sciences, Academic, and Commercial market sectors. They partner with many of Boston's top Universities and Hospitals, resulting in 80%+ of business coming from repeat clients. Looking for an experienced Construction Project Manager to support a variety of upcoming healthcare projects in the local area. Description As the Project Manager you will: Establish the project control plan. Control the rate of production and quality on all projects, their associated cost and expected receipts. Establish base line and monitor construction schedules. Insure construction schedules are adhered and deadlines met. Secure building permits, licenses and occupancy certificates. Monitor/control construction through administrative direction of on-site Superintendent to ensure building the project on schedule and within budget. Investigate potentially serious situations and implement corrective measures. Manage financial aspects of contracts (fee payment, rental equipment, income/expenses, etc.) to protect company's interest and simultaneously maintain good relationship with client and Architect. Review job cost reports and maintain accurate and timely indicated cost reporting. Coordinate meetings with Owner's representatives, Architects/Engineers for obtaining approvals to jointly discuss procedures, progress, problems and scheduling. Assist in preparation of bid day information. Author and issue meeting minutes promptly. Schedule and assist in progress meetings with Trade Contractors and Construction Superintendents. Secure scheduling for equipment, material, shop drawing submittals and deliveries. Assume additional responsibilities or special projects as needed Profile The successful Project Manager will have: Bachelor's Degree in Construction Management, Engineering, Building Construction Technology, or related field preferred 10+ years of experience as a Project Manager General Contractor experience required Project background in Healthcare, Life Sciences, Academic or related Ability to plan, organize, and coordinate multiple projects Strong literacy of MS Word and Excel Working understanding of Timberline/Sage software Strong communication and interpersonal skills Job Offer The Project Manager will receive: Competitive base salary Comprehensive benefits package - 100% employer paid 401K with match 3 weeks PTO Flex scheduling Unlimited upward mobility MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
02/08/2023
Full time
Michael Page is currently hiring for a Construction Project Manager to join one of Boston's most established General Contractors in Boston! Client Details My client has been serving the Greater Boston Construction market for 60+ years, across Healthcare, Life Sciences, Academic, and Commercial market sectors. They partner with many of Boston's top Universities and Hospitals, resulting in 80%+ of business coming from repeat clients. Looking for an experienced Construction Project Manager to support a variety of upcoming healthcare projects in the local area. Description As the Project Manager you will: Establish the project control plan. Control the rate of production and quality on all projects, their associated cost and expected receipts. Establish base line and monitor construction schedules. Insure construction schedules are adhered and deadlines met. Secure building permits, licenses and occupancy certificates. Monitor/control construction through administrative direction of on-site Superintendent to ensure building the project on schedule and within budget. Investigate potentially serious situations and implement corrective measures. Manage financial aspects of contracts (fee payment, rental equipment, income/expenses, etc.) to protect company's interest and simultaneously maintain good relationship with client and Architect. Review job cost reports and maintain accurate and timely indicated cost reporting. Coordinate meetings with Owner's representatives, Architects/Engineers for obtaining approvals to jointly discuss procedures, progress, problems and scheduling. Assist in preparation of bid day information. Author and issue meeting minutes promptly. Schedule and assist in progress meetings with Trade Contractors and Construction Superintendents. Secure scheduling for equipment, material, shop drawing submittals and deliveries. Assume additional responsibilities or special projects as needed Profile The successful Project Manager will have: Bachelor's Degree in Construction Management, Engineering, Building Construction Technology, or related field preferred 10+ years of experience as a Project Manager General Contractor experience required Project background in Healthcare, Life Sciences, Academic or related Ability to plan, organize, and coordinate multiple projects Strong literacy of MS Word and Excel Working understanding of Timberline/Sage software Strong communication and interpersonal skills Job Offer The Project Manager will receive: Competitive base salary Comprehensive benefits package - 100% employer paid 401K with match 3 weeks PTO Flex scheduling Unlimited upward mobility MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
Over all departmental office management. Ensure timely processing and accurate documentation of Property work orders, purchase orders/check requests, time sheets, etc. Assist with the development and maintenance of the department database. Prepare reports from database (e.g. monthly payroll allocation reports, project expenditure reports). Provide liaison with Accounting and other Departments. Maintenance and organization of departmental files. Evaluate purchase options for best buy of department office supplies, equipment and services. Process orders for department equipment and supplies. Maintain insurance records of vendors used by department. Process and coordinate vehicle and real property insurance claims. Assist in preparation of department written procedures. Train staff on systems to gain needed proficiency to do their jobs effectively. Identify and address safety hazards in the office environment. Perform other duties and projects as assigned by the Property Director. Demonstrated ability to work effectively and collaboratively with a culturally diverse staff. Professional documentation and communication skills, as well as demonstrated organizational skills. Ability to work efficiently while maintaining accuracy and quality. Demonstrated ability to collaboratively while handling multiple responsibilities in a fast paced and challenging environment. Demonstrated ability to work independently and with in a team context. Ability to be flexible. Filemaker Pro software experience a plus but will train Strong organizational, typing, interpersonal and verbal / written communication skills. Demonstrated proficiency in MS Word and Excel. A COVID-19 vaccination is a requirement of the position. One COVID-19 shot is acceptable, contingent on the individual receiving the second shot within the allotted time frame.
02/08/2023
Full time
Over all departmental office management. Ensure timely processing and accurate documentation of Property work orders, purchase orders/check requests, time sheets, etc. Assist with the development and maintenance of the department database. Prepare reports from database (e.g. monthly payroll allocation reports, project expenditure reports). Provide liaison with Accounting and other Departments. Maintenance and organization of departmental files. Evaluate purchase options for best buy of department office supplies, equipment and services. Process orders for department equipment and supplies. Maintain insurance records of vendors used by department. Process and coordinate vehicle and real property insurance claims. Assist in preparation of department written procedures. Train staff on systems to gain needed proficiency to do their jobs effectively. Identify and address safety hazards in the office environment. Perform other duties and projects as assigned by the Property Director. Demonstrated ability to work effectively and collaboratively with a culturally diverse staff. Professional documentation and communication skills, as well as demonstrated organizational skills. Ability to work efficiently while maintaining accuracy and quality. Demonstrated ability to collaboratively while handling multiple responsibilities in a fast paced and challenging environment. Demonstrated ability to work independently and with in a team context. Ability to be flexible. Filemaker Pro software experience a plus but will train Strong organizational, typing, interpersonal and verbal / written communication skills. Demonstrated proficiency in MS Word and Excel. A COVID-19 vaccination is a requirement of the position. One COVID-19 shot is acceptable, contingent on the individual receiving the second shot within the allotted time frame.
Who We Are Boston Consulting Group partners with leaders in business and society to tackle their most important challenges and capture their greatest opportunities. BCG was the pioneer in business strategy when it was founded in 1963. Today, we work closely with clients to embrace a transformational approach aimed at benefiting all stakeholders-empowering organizations to grow, build sustainable competitive advantage, and drive positive societal impact. Our diverse, global teams bring deep industry and functional expertise and a range of perspectives that question the status quo and spark change. BCG delivers solutions through leading-edge management consulting, technology and design, and corporate and digital ventures. We work in a uniquely collaborative model across the firm and throughout all levels of the client organization, fueled by the goal of helping our clients thrive and enabling them to make the world a better place. Practice Area Profile Through People & Organization, BCG works with our clients - senior business executives- who value BCG's strategic, fact-based, and impact-oriented approach supported by senior teams, rich benchmarking databases and analytical capabilities. We provide expertise to our clients across all industries through our capabilities in areas like Organization Design; Change Management; Shared Services and Support Functions; Culture, Purpose and Engagement; Leadership & Talent; and Agile Ways of Working. What You'll Do BCG's purpose is to "Unlock the Potential of Those Who Advance the World". At BCG U, we contribute to that unlock through next generation, large-scale learning solutions that build an organization's capability to transform in a transforming world. Our focus is on ensuring leaders and teams at every level have the knowledge and skills they need to play their pivotal role in realizing value and impact. BCG is looking to fill several senior Learning Architect roles on the BCG U team to help us engineer impactful capability building into large-scale transformations. You will be joining a global team of people and organization experts passionate about this topic to help build and deploy the cutting-edge learning solutions and to advise on the learning infrastructure required to unleash the power of talent in organizations that are on ambitious journeys to transform. As a Learning Architect you will partner closely with clients to assess learning ecosystem maturity, shape talent development strategies, design and implement innovative capability building solutions, and reinforce learning as a key lever to accelerate the delivery of target business outcomes that capture transformation value. You will play a leading role in the shaping, building and commercializing of BCG U's go-to-market offers and resources in capability building, including immersive programs in transformational topics (e.g., Digital, Agile, Change, Sustainability) that incorporate best-practice learning design approaches, cutting-edge education technology solutions and performance support tools, and the discipline of measuring meaningful outcomes from learning interventions. You will play a leadership role in defining and implementing the next frontier for corporate learning, and in mobilizing our diverse BCG U team toward that objective. Our Expert Consulting Track (ECT) The Expert Consulting Track (ECT) is vital to BCG's ability to successfully meet our clients' demand for deep expertise and advanced technical capabilities. Experts deliver next-level impact for BCG's most complex and cutting-edge client challenges. Experts focus on developing BCG's thought leadership, commercial capabilities, and intellectual property assets; and their work is essential to our delivery model. Working as part of a multidisciplinary team to bring the 'best of BCG' to our clients, Experts come from diverse backgrounds, with expertise often gained outside of BCG in industry, academia, or specialized consulting. What You'll Bring (Experience & Qualifications) 7-15 years of work experience; experience in top level advisory or consulting environment preferred Track record in building and implementing end-to-end talent development programs for large organizations in private and public sectors Evidence of breaking the "status quo" in corporate learning, implementing innovative, immersive and scalable solutions that drive tangible business impact Experience in building key elements of the required infrastructure supporting capability building programs in large organizations (e.g. lead role in a Corporate University or Learning Innovation unit, learning tech stack implementation, creating a high-quality delivery cadre, etc.) A track record of building, growing and leading multi-disciplinary teams Entrepreneurial spirit and initiative Passion for using learning to drive outcomes PREFERRED SKILLS Strategic vision for corporate learning and development Ability to design end-to-end talent development solutions Strong leadership and interpersonal skills Tenacity and growth mindset WHO YOU'LL WORK WITH: You will join our People and Organization practice and be part of our global people and organization community of experts. Day-to-day you will collaborate with different Clients and BCG project teams, as well as Topic and Practice area stakeholders across BCG. YOU'LL BE BASED IN: Dallas or Boston locations preferred but will also consider candidates in New York, Atlanta, or Chicago. YOU'LL BE TRAVELING: Travel is anticipated and estimated at 20-40% in order to engage with teams and clients on an as needed basis. VACCINE: Candidates should be aware that BCG currently maintains a policy requiring all US & Canada based employees to be fully vaccinated against COVID-19. Newly hired employees must be fully vaccinated prior to their employment start date. BCG is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated for medical or religious reasons where it is not an undue hardship to the company to do so as provided under applicable federal, state, provincial and local law. FOR U.S. APPLICANTS: Boston Consulting Company ("BCG") is an Equal Opportunity/Affirmative Action employer. All qualified applicants will be considered for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by applicable law. The first year base compensation for this role is: Consultant: $190,000 USD Project Leader: $225,400 USD Associate Director: $252,900 USD Partner and Associate Director: $287,000 USD In addition to your base salary, you will also be eligible for an annual discretionary performance bonus and BCG's Profit Sharing and Retirement Fund (PSRF) contribution. BCG also provides a market leading benefits package described below. At BCG, we are committed to offering a comprehensive benefit program that includes everything our employees and their families need to be well and live life to the fullest. We pay the full cost of medical, dental, and vision coverage for employees - and their eligible family members. That's zero dollars in premiums taken from employee paychecks. All our plans provide best in class coverage: Zero dollar ($0) health insurance premiums for BCG employees, spouses, and children Low $5 (USD) copays for trips to the doctor, urgent care visits and prescriptions for generic drugs Dental coverage, including up to $5,000 (USD) in orthodontia benefits Vision insurance with coverage for both glasses and contact lenses annually Reimbursement for gym memberships and other fitness activities Fully vested retirement contributions made annually, whether you contribute or not Generous paid time off including vacation, holidays, and annual office closure between Christmas and New Years Paid Parental Leave and other family benefits such as elective egg freezing, surrogacy, and adoption reimbursement Employees, spouses, and children are covered at no cost. Employees share in the cost of domestic partner coverage. Requirements: Boston Consulting Group
02/08/2023
Full time
Who We Are Boston Consulting Group partners with leaders in business and society to tackle their most important challenges and capture their greatest opportunities. BCG was the pioneer in business strategy when it was founded in 1963. Today, we work closely with clients to embrace a transformational approach aimed at benefiting all stakeholders-empowering organizations to grow, build sustainable competitive advantage, and drive positive societal impact. Our diverse, global teams bring deep industry and functional expertise and a range of perspectives that question the status quo and spark change. BCG delivers solutions through leading-edge management consulting, technology and design, and corporate and digital ventures. We work in a uniquely collaborative model across the firm and throughout all levels of the client organization, fueled by the goal of helping our clients thrive and enabling them to make the world a better place. Practice Area Profile Through People & Organization, BCG works with our clients - senior business executives- who value BCG's strategic, fact-based, and impact-oriented approach supported by senior teams, rich benchmarking databases and analytical capabilities. We provide expertise to our clients across all industries through our capabilities in areas like Organization Design; Change Management; Shared Services and Support Functions; Culture, Purpose and Engagement; Leadership & Talent; and Agile Ways of Working. What You'll Do BCG's purpose is to "Unlock the Potential of Those Who Advance the World". At BCG U, we contribute to that unlock through next generation, large-scale learning solutions that build an organization's capability to transform in a transforming world. Our focus is on ensuring leaders and teams at every level have the knowledge and skills they need to play their pivotal role in realizing value and impact. BCG is looking to fill several senior Learning Architect roles on the BCG U team to help us engineer impactful capability building into large-scale transformations. You will be joining a global team of people and organization experts passionate about this topic to help build and deploy the cutting-edge learning solutions and to advise on the learning infrastructure required to unleash the power of talent in organizations that are on ambitious journeys to transform. As a Learning Architect you will partner closely with clients to assess learning ecosystem maturity, shape talent development strategies, design and implement innovative capability building solutions, and reinforce learning as a key lever to accelerate the delivery of target business outcomes that capture transformation value. You will play a leading role in the shaping, building and commercializing of BCG U's go-to-market offers and resources in capability building, including immersive programs in transformational topics (e.g., Digital, Agile, Change, Sustainability) that incorporate best-practice learning design approaches, cutting-edge education technology solutions and performance support tools, and the discipline of measuring meaningful outcomes from learning interventions. You will play a leadership role in defining and implementing the next frontier for corporate learning, and in mobilizing our diverse BCG U team toward that objective. Our Expert Consulting Track (ECT) The Expert Consulting Track (ECT) is vital to BCG's ability to successfully meet our clients' demand for deep expertise and advanced technical capabilities. Experts deliver next-level impact for BCG's most complex and cutting-edge client challenges. Experts focus on developing BCG's thought leadership, commercial capabilities, and intellectual property assets; and their work is essential to our delivery model. Working as part of a multidisciplinary team to bring the 'best of BCG' to our clients, Experts come from diverse backgrounds, with expertise often gained outside of BCG in industry, academia, or specialized consulting. What You'll Bring (Experience & Qualifications) 7-15 years of work experience; experience in top level advisory or consulting environment preferred Track record in building and implementing end-to-end talent development programs for large organizations in private and public sectors Evidence of breaking the "status quo" in corporate learning, implementing innovative, immersive and scalable solutions that drive tangible business impact Experience in building key elements of the required infrastructure supporting capability building programs in large organizations (e.g. lead role in a Corporate University or Learning Innovation unit, learning tech stack implementation, creating a high-quality delivery cadre, etc.) A track record of building, growing and leading multi-disciplinary teams Entrepreneurial spirit and initiative Passion for using learning to drive outcomes PREFERRED SKILLS Strategic vision for corporate learning and development Ability to design end-to-end talent development solutions Strong leadership and interpersonal skills Tenacity and growth mindset WHO YOU'LL WORK WITH: You will join our People and Organization practice and be part of our global people and organization community of experts. Day-to-day you will collaborate with different Clients and BCG project teams, as well as Topic and Practice area stakeholders across BCG. YOU'LL BE BASED IN: Dallas or Boston locations preferred but will also consider candidates in New York, Atlanta, or Chicago. YOU'LL BE TRAVELING: Travel is anticipated and estimated at 20-40% in order to engage with teams and clients on an as needed basis. VACCINE: Candidates should be aware that BCG currently maintains a policy requiring all US & Canada based employees to be fully vaccinated against COVID-19. Newly hired employees must be fully vaccinated prior to their employment start date. BCG is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated for medical or religious reasons where it is not an undue hardship to the company to do so as provided under applicable federal, state, provincial and local law. FOR U.S. APPLICANTS: Boston Consulting Company ("BCG") is an Equal Opportunity/Affirmative Action employer. All qualified applicants will be considered for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by applicable law. The first year base compensation for this role is: Consultant: $190,000 USD Project Leader: $225,400 USD Associate Director: $252,900 USD Partner and Associate Director: $287,000 USD In addition to your base salary, you will also be eligible for an annual discretionary performance bonus and BCG's Profit Sharing and Retirement Fund (PSRF) contribution. BCG also provides a market leading benefits package described below. At BCG, we are committed to offering a comprehensive benefit program that includes everything our employees and their families need to be well and live life to the fullest. We pay the full cost of medical, dental, and vision coverage for employees - and their eligible family members. That's zero dollars in premiums taken from employee paychecks. All our plans provide best in class coverage: Zero dollar ($0) health insurance premiums for BCG employees, spouses, and children Low $5 (USD) copays for trips to the doctor, urgent care visits and prescriptions for generic drugs Dental coverage, including up to $5,000 (USD) in orthodontia benefits Vision insurance with coverage for both glasses and contact lenses annually Reimbursement for gym memberships and other fitness activities Fully vested retirement contributions made annually, whether you contribute or not Generous paid time off including vacation, holidays, and annual office closure between Christmas and New Years Paid Parental Leave and other family benefits such as elective egg freezing, surrogacy, and adoption reimbursement Employees, spouses, and children are covered at no cost. Employees share in the cost of domestic partner coverage. Requirements: Boston Consulting Group
To give you a better idea of job, I'll just give you the inside scoop here. As part of the marketing team responsible for marketing Seibert Media's products and services, I created a variety of graphic content for the draw.io product. This includes, for example, developing the corporate design, designing websites and landing pages, or creating online advertising banners, social media graphics and newsletters. Holistic event design - from the creation of roll-ups and flyers to trade show booth design - was also part of my job. I was involved in all project stages - conception, design, implementation and testing - and also contributed to the establishment of design guides and design systems.
02/08/2023
Full time
To give you a better idea of job, I'll just give you the inside scoop here. As part of the marketing team responsible for marketing Seibert Media's products and services, I created a variety of graphic content for the draw.io product. This includes, for example, developing the corporate design, designing websites and landing pages, or creating online advertising banners, social media graphics and newsletters. Holistic event design - from the creation of roll-ups and flyers to trade show booth design - was also part of my job. I was involved in all project stages - conception, design, implementation and testing - and also contributed to the establishment of design guides and design systems.
When you join us, you will be the link between the content and sales teams and take care of these tasks: Together with the sales teams, you figure out how to improve our content so that it can be used in the best possible way, and evaluate the performance and success of that content. Plan videos, implement them with the video crew, and publish them. Of course, coordinating the creation of blogposts and content in our websites with our content team is just as much a part of the job as planning and analyzing ad campaigns in Google Ads and on LinkedIn. You'll also assist with targeted campaigns for individual services with marketing materials, mail campaigns, tracking support in HubSpot or similar.
02/08/2023
Full time
When you join us, you will be the link between the content and sales teams and take care of these tasks: Together with the sales teams, you figure out how to improve our content so that it can be used in the best possible way, and evaluate the performance and success of that content. Plan videos, implement them with the video crew, and publish them. Of course, coordinating the creation of blogposts and content in our websites with our content team is just as much a part of the job as planning and analyzing ad campaigns in Google Ads and on LinkedIn. You'll also assist with targeted campaigns for individual services with marketing materials, mail campaigns, tracking support in HubSpot or similar.
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: As a Senior Research Associate- Oncology Data Science, you will report to the data science lead in the Computational Oncology team which consists of accomplished computational biologists. You will contribute to our mission to provide innovative cancer therapies to patients across our pipeline of novel immuno-oncology therapeutics. Your will apply modern computational approaches to scientific and data science problems and will be influential across the entire drug discovery spectrum. You will contribute to projects moving from target identification and validation through early clinical proof of concept, providing translational hypotheses and predictive and pharmacodynamic biomarkers to inform early clinical development strategies. How you will contribute: Help build data science capabilities in the Computational Oncology group, including pipelines, computational infrastructure, databases, and AI/ML platforms Use internal and external high dimensional datasets to build novel machine learning models for selection and prediction of relevant features/outcomes. Collaborate with data science and data engineering groups, and vendors, to build and onboard platforms to enhance data storage/query/visualization, user interfaces, reproducible research, and other capabilities Prepare and present comprehensive technical or project reports to a full range of internal and external audiences. Work with functional and program leadership to develop and implement a computational biology roadmap and strategies. Minimum Requirements/Qualifications: M.S. with 2+ years of experience in data science, machine learning, oncology research and translation or B.S. with 5+ years of experience Programming skills in any programming language Knowledge of Unix/Linux, command line interfaces, and fluency in some common scripting and programming language (e.g., R, Python, Perl, Java, C / C++). Familiar with parallel computing, relational databases (e.g., SQL) and cloud computing or distributed computing (i.e. AWS) and workflow management. Experience applying statistical methods and machine learning algorithms to large datasets, such as 'omics or image data Have scientific understanding of molecular biology and genomics. Theoretical knowledge of bioinformatics, computational biology and machine learning. Keep current with latest trends in bioinformatics and computational biology and machine learning algorithms. Familiar with popular public domain data sources and programmatic interfaces. What Takeda can offer you: Comprehensive Healthcare: Medical, Dental, and Vision Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs and company match of charitable contributions Family Planning Support Flexible Work Paths Tuition reimbursement More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
02/08/2023
Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: As a Senior Research Associate- Oncology Data Science, you will report to the data science lead in the Computational Oncology team which consists of accomplished computational biologists. You will contribute to our mission to provide innovative cancer therapies to patients across our pipeline of novel immuno-oncology therapeutics. Your will apply modern computational approaches to scientific and data science problems and will be influential across the entire drug discovery spectrum. You will contribute to projects moving from target identification and validation through early clinical proof of concept, providing translational hypotheses and predictive and pharmacodynamic biomarkers to inform early clinical development strategies. How you will contribute: Help build data science capabilities in the Computational Oncology group, including pipelines, computational infrastructure, databases, and AI/ML platforms Use internal and external high dimensional datasets to build novel machine learning models for selection and prediction of relevant features/outcomes. Collaborate with data science and data engineering groups, and vendors, to build and onboard platforms to enhance data storage/query/visualization, user interfaces, reproducible research, and other capabilities Prepare and present comprehensive technical or project reports to a full range of internal and external audiences. Work with functional and program leadership to develop and implement a computational biology roadmap and strategies. Minimum Requirements/Qualifications: M.S. with 2+ years of experience in data science, machine learning, oncology research and translation or B.S. with 5+ years of experience Programming skills in any programming language Knowledge of Unix/Linux, command line interfaces, and fluency in some common scripting and programming language (e.g., R, Python, Perl, Java, C / C++). Familiar with parallel computing, relational databases (e.g., SQL) and cloud computing or distributed computing (i.e. AWS) and workflow management. Experience applying statistical methods and machine learning algorithms to large datasets, such as 'omics or image data Have scientific understanding of molecular biology and genomics. Theoretical knowledge of bioinformatics, computational biology and machine learning. Keep current with latest trends in bioinformatics and computational biology and machine learning algorithms. Familiar with popular public domain data sources and programmatic interfaces. What Takeda can offer you: Comprehensive Healthcare: Medical, Dental, and Vision Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs and company match of charitable contributions Family Planning Support Flexible Work Paths Tuition reimbursement More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. How you will contribute: Leads the chemical/synthetic molecule CMC regulatory team in the development and implementation of global CMC regulatory strategies for products throughout development and commercial lifecycle. Combines knowledge of scientific, regulatory and business issues to ensure the registration and life cycle maintenance (CMC regulatory aspects) of products are of high quality and right first time. Maintain up-to-date knowledge and expertise of relevant CMC and quality guidelines and regulations and establishes mechanisms to communicate them to relevant stakeholders, thereby driving prospective and proactive implementation. Globally influences and is generally considered a key opinion leader and resource within Takeda and externally with stakeholders in HA and in Industry. Influences changing regulations and guidance documents; interfaces with outside regulatory agencies and trade associations and acts as an advisor/liaison to senior management to plan, evaluate and recommend implementation strategy. Establish collaboration with Global CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives. Responsible for demonstrating Takeda leadership behaviors. Serve as a member of the GRA-CMC Leadership team, giving input to key strategic, portfolio, human capital and financial decisions. Provides leadership of GRA CMC Pharmaceuticals regulatory team and in conjunction with direct reports, manages resources, establish a vision, and collaborate with stakeholders in global Reg CMC and across the enterprise to deliver against them. Inconjunction with members of the team, develop as well as oversee development (including updates) and communication of proactive regulatory CMC strategies to global CMC regulatory teams and stakeholders in a timely manner Builds and manages relationships through active partnering with key internal (GRA, GRA CMC, Pharmaceutical Sciences, GMS, GQ etc.) and external stakeholders (Health authorities, Industry counterparts/associations, academia). Relationship management and constructive partnering with Health Authorities and relevant industry organizations to drive Takeda position and influence scientific approach and thought process to CMC topics. Ensures team effectiveness in working across a very complex matrix environment in GRA with CMC RA project leads and other GRA sub-functions, as needed to ensure effective strategies are developed and project execution is on target. Build and maintain communication strategy and platform for all staff across the organization. Responsible for timely dissemination of regulations, guidelines and data to staff and stakeholders via team sites or intranet. Actively engage and influence organization to think proactively and utilize science and risk based approach to product development and LCM activities. Contribute to creating and communicating an employment culture and values which attract, retain, and develop the most effective people. Ensure compliance with all applicable Takeda SOPs, local and international regulations, and industry best-practice. Represents, as required, the regulatory function in the evaluation of new product opportunities internally and externally. Leads or plays a key role on the relevant internal Takeda governance committees Minimum Requirements/Qualifications: Advanced Degree or PhD in Life Sciences, Pharmacy or Medicines, or related discipline. Languages: Fluent in English (oral and written); additional languages desirable Minimum of 20 years of experience within regulatory agencies or the Pharmaceutical Industry including significant leadership experience in Regulatory Sciences Significant understanding and track record in dealing with international regulations and policies setting processes of major regulatory agencies (e.g. US FDA, EU, PMDA, NMPA, WHO). Actively engaged in major industry associations (e.g. EFPIA, BIO, PhRMA, CASSS, PDA, ISPE, DIA) and joint regulator/industry initiatives (e.g. ICH). Strong communication, collaboration, negotiation, problem solving and interpersonal skills. Has a proven track record of working across regulator/industry boundaries to find common solutions and drive positive impact and benefits for patients. High organization awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in teams. What Takeda can offer you: Comprehensive Healthcare: Medical, Dental, and Vision Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation Community Outreach Programs and company match of charitable contributions Family Planning Support Flexible Work Paths Tuition reimbursement More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy. Base Salary Range: $193,200- $276,000, based on candidate professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off. The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
02/08/2023
Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. How you will contribute: Leads the chemical/synthetic molecule CMC regulatory team in the development and implementation of global CMC regulatory strategies for products throughout development and commercial lifecycle. Combines knowledge of scientific, regulatory and business issues to ensure the registration and life cycle maintenance (CMC regulatory aspects) of products are of high quality and right first time. Maintain up-to-date knowledge and expertise of relevant CMC and quality guidelines and regulations and establishes mechanisms to communicate them to relevant stakeholders, thereby driving prospective and proactive implementation. Globally influences and is generally considered a key opinion leader and resource within Takeda and externally with stakeholders in HA and in Industry. Influences changing regulations and guidance documents; interfaces with outside regulatory agencies and trade associations and acts as an advisor/liaison to senior management to plan, evaluate and recommend implementation strategy. Establish collaboration with Global CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives. Responsible for demonstrating Takeda leadership behaviors. Serve as a member of the GRA-CMC Leadership team, giving input to key strategic, portfolio, human capital and financial decisions. Provides leadership of GRA CMC Pharmaceuticals regulatory team and in conjunction with direct reports, manages resources, establish a vision, and collaborate with stakeholders in global Reg CMC and across the enterprise to deliver against them. Inconjunction with members of the team, develop as well as oversee development (including updates) and communication of proactive regulatory CMC strategies to global CMC regulatory teams and stakeholders in a timely manner Builds and manages relationships through active partnering with key internal (GRA, GRA CMC, Pharmaceutical Sciences, GMS, GQ etc.) and external stakeholders (Health authorities, Industry counterparts/associations, academia). Relationship management and constructive partnering with Health Authorities and relevant industry organizations to drive Takeda position and influence scientific approach and thought process to CMC topics. Ensures team effectiveness in working across a very complex matrix environment in GRA with CMC RA project leads and other GRA sub-functions, as needed to ensure effective strategies are developed and project execution is on target. Build and maintain communication strategy and platform for all staff across the organization. Responsible for timely dissemination of regulations, guidelines and data to staff and stakeholders via team sites or intranet. Actively engage and influence organization to think proactively and utilize science and risk based approach to product development and LCM activities. Contribute to creating and communicating an employment culture and values which attract, retain, and develop the most effective people. Ensure compliance with all applicable Takeda SOPs, local and international regulations, and industry best-practice. Represents, as required, the regulatory function in the evaluation of new product opportunities internally and externally. Leads or plays a key role on the relevant internal Takeda governance committees Minimum Requirements/Qualifications: Advanced Degree or PhD in Life Sciences, Pharmacy or Medicines, or related discipline. Languages: Fluent in English (oral and written); additional languages desirable Minimum of 20 years of experience within regulatory agencies or the Pharmaceutical Industry including significant leadership experience in Regulatory Sciences Significant understanding and track record in dealing with international regulations and policies setting processes of major regulatory agencies (e.g. US FDA, EU, PMDA, NMPA, WHO). Actively engaged in major industry associations (e.g. EFPIA, BIO, PhRMA, CASSS, PDA, ISPE, DIA) and joint regulator/industry initiatives (e.g. ICH). Strong communication, collaboration, negotiation, problem solving and interpersonal skills. Has a proven track record of working across regulator/industry boundaries to find common solutions and drive positive impact and benefits for patients. High organization awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in teams. What Takeda can offer you: Comprehensive Healthcare: Medical, Dental, and Vision Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation Community Outreach Programs and company match of charitable contributions Family Planning Support Flexible Work Paths Tuition reimbursement More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy. Base Salary Range: $193,200- $276,000, based on candidate professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off. The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
Inozyme Pharma is seeking a Corporate Controller, to join our growing Finance team. This position will report to the Chief Financial Officer. Inozyme Pharma, Inc. (Nasdaq: INZY) is a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of diseases of abnormal mineralization impacting the vasculature, soft tissue, and skeleton. Through our in-depth understanding of the biological pathways involved in mineralization, we are pursuing the development of therapeutics to address the underlying causes of these debilitating diseases. It is well established that two genes, ENPP1 and ABCC6,play key roles in a critical mineralization pathway and that defects in these genes lead to abnormal mineralization. We are initially focused on developing a novel therapy, INZ-701, to treat the rare genetic diseases of ENPP1 and ABCC6Deficiencies. INZ-701 is currently in Phase 1/2 clinical trials for the treatment of ENPP1 Deficiency and ABCC6 Deficiency. The Corporate Controller will lead the accounting activities of the organization to support the needs and requirements of a publicly traded company. He/She will have overall responsibility for the accounting process, provision of GAAP financial statements, SEC reporting, tax matters and external auditor engagement. The Corporate Controller will partner with non-finance executives and managers to engage and gather information on Company activities to improve business processes, enable effective decision making and track corporate performance. Responsibilities: Lead all financial and accounting activities including SEC reporting Certify quarterly and annual reports are consistent with GAAP Ensure SOX compliance Build a best-in-class accounting function; motivate and develop talent Partner closely with third parties to manage annual audits, third party valuations, filings, taxes, and other corporate accounting activities Lead preparation of financial updates ,analysis, and board content for leadership team, Board of Directors, and investors Oversee the month end close, including but not limited to preparing and reviewing journal entries and balance sheet reconciliations Prepare technical accounting memorandums as needed as well as continue to improve on and strengthen the internal control environment Foster an environment of continuous improvement to identify, develop, and implement process changes and systems to increase efficiency, ensure accurate reporting, and build scalable accounting processes Partner with all cross functional leadership in Research, Tech Ops, Commercial and Clinical teams to forecast and account for discovery and development projects and major collaborations Develop KPIs to monitor and evaluate financial and operational initiatives; Synthesize and communicate information to key stakeholders and executive management Perform or participate in special projects or ad hoc assignments Qualifications: MBA/MS degree in Finance or Accounting 12+ years of relevant experience within Life Sciences or Biotechnology industries required. CPA certification; knowledge of accounting principles including (GAAP and GAAS) general and cost accounting, tax reporting and budgeting Financial reporting and accounting expertise in proxy preparation (Def 14A) with SEC (specifically ASC 718 experience)required. "Big Four" or national accounting firm audit experience preferred Experience leading and mentoring an accounting function, preferably in a public biotech company. Demonstrated management and interpersonal skills Systems implementation experience preferred Maintain high ethical and professional standards Ability to work in a team environment and participate as an active member of management Effective oral and written business communication skills Analytical, statistical, personal organization, andproblem-solving skills; able to organize, prioritize, and execute a variableworkload and multiple priorities Apply now EEOC Statement: To all recruitment agencies: Inozyme Pharma, Inc. does not accept agency resumes. Please do not forward resumes to our job's alias, Inozyme employees or any other organization location. Inozyme is not responsible for any fees related to unsolicited resumes.
02/08/2023
Full time
Inozyme Pharma is seeking a Corporate Controller, to join our growing Finance team. This position will report to the Chief Financial Officer. Inozyme Pharma, Inc. (Nasdaq: INZY) is a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of diseases of abnormal mineralization impacting the vasculature, soft tissue, and skeleton. Through our in-depth understanding of the biological pathways involved in mineralization, we are pursuing the development of therapeutics to address the underlying causes of these debilitating diseases. It is well established that two genes, ENPP1 and ABCC6,play key roles in a critical mineralization pathway and that defects in these genes lead to abnormal mineralization. We are initially focused on developing a novel therapy, INZ-701, to treat the rare genetic diseases of ENPP1 and ABCC6Deficiencies. INZ-701 is currently in Phase 1/2 clinical trials for the treatment of ENPP1 Deficiency and ABCC6 Deficiency. The Corporate Controller will lead the accounting activities of the organization to support the needs and requirements of a publicly traded company. He/She will have overall responsibility for the accounting process, provision of GAAP financial statements, SEC reporting, tax matters and external auditor engagement. The Corporate Controller will partner with non-finance executives and managers to engage and gather information on Company activities to improve business processes, enable effective decision making and track corporate performance. Responsibilities: Lead all financial and accounting activities including SEC reporting Certify quarterly and annual reports are consistent with GAAP Ensure SOX compliance Build a best-in-class accounting function; motivate and develop talent Partner closely with third parties to manage annual audits, third party valuations, filings, taxes, and other corporate accounting activities Lead preparation of financial updates ,analysis, and board content for leadership team, Board of Directors, and investors Oversee the month end close, including but not limited to preparing and reviewing journal entries and balance sheet reconciliations Prepare technical accounting memorandums as needed as well as continue to improve on and strengthen the internal control environment Foster an environment of continuous improvement to identify, develop, and implement process changes and systems to increase efficiency, ensure accurate reporting, and build scalable accounting processes Partner with all cross functional leadership in Research, Tech Ops, Commercial and Clinical teams to forecast and account for discovery and development projects and major collaborations Develop KPIs to monitor and evaluate financial and operational initiatives; Synthesize and communicate information to key stakeholders and executive management Perform or participate in special projects or ad hoc assignments Qualifications: MBA/MS degree in Finance or Accounting 12+ years of relevant experience within Life Sciences or Biotechnology industries required. CPA certification; knowledge of accounting principles including (GAAP and GAAS) general and cost accounting, tax reporting and budgeting Financial reporting and accounting expertise in proxy preparation (Def 14A) with SEC (specifically ASC 718 experience)required. "Big Four" or national accounting firm audit experience preferred Experience leading and mentoring an accounting function, preferably in a public biotech company. Demonstrated management and interpersonal skills Systems implementation experience preferred Maintain high ethical and professional standards Ability to work in a team environment and participate as an active member of management Effective oral and written business communication skills Analytical, statistical, personal organization, andproblem-solving skills; able to organize, prioritize, and execute a variableworkload and multiple priorities Apply now EEOC Statement: To all recruitment agencies: Inozyme Pharma, Inc. does not accept agency resumes. Please do not forward resumes to our job's alias, Inozyme employees or any other organization location. Inozyme is not responsible for any fees related to unsolicited resumes.
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda Cell Therapy Innovation (CTI) team as Senior Scientist/Principal Scientist, where you will help establish correlative analysis practice, building in-depth data analysis workflow, designing engineering biology within CTI and bridging CTI with data scientists and bioinformatician within Takeda. If you are motivated by designing complex cellular systems and distilling insight from large biological datasets, this role will be ideal for you. This is a unique opportunity to work at a start-up like culture in big pharmaceutical company to contribute to engineering biology and process biology of cell therapy product. We seek a motivated and collaborative scientist with experience applying data science and computational biology to the discovery and development of cell therapy products. Our cell therapy innovation team is focused on advancing Takeda cell therapy drug discovery through cutting-edge technologies. How you will contribute: You will lead the efforts in building correlative science and computational biology strategy in CTI working with all cross-function partners and leadership teams You will build data collection, data annotation, data cleaning and dataset compile for specific projects and downstream in-depth data correlative analysis Dive deep in high dimension NGS data using RNAseq, genome sequencing, and others to inform gene engineering biology Explore large data set of variety readouts, including immunophenotype, cell production yield and transducibility, Legend screen, cytokine profiling, function assessment etc to help with donor selection criteria set up Work with bench scientists by guiding experimental workflows and quantitative measurement to ensure statistical rigor and help building data visualization Collaborate with Precision Translational Medicine, Data Science Institute, and Data/Automation in CMC & Global Biologics to build enterprise digitization roadmap and explore new tool and technology platform Minimum Requirements/Qualifications: PhD's degree in Computer Science, bioinformatics, computational biology, system biology or other similar science and engineering disciplines, with 3+ year experience Master's degree in Computer Science, bioinformatics, computational biology, system biology or other similar science and engineering disciplines, with 7+ year experience Bachelor's degree in Computer Science, bioinformatics, computational biology, system biology or other similar science and engineering disciplines, with 10+ year experience Technical Requirements: Basic understanding of molecular biology, immunology, cell biology, and cell therapy product development Experience with at least one of the focuses: protein or DNA sequence design, natural language processing, text mining, omics data analysis (RNA seq, etc.), computer vision Expertise with many of the following areas: supervised learning, unsupervised learning, deep learning, deep generative models, transfer learning, etc. Experience working in cloud and high-performance computing environments (e.g. AWS), and experience working in a Unix/Linux environment Excellence in core machine learning languages (such as Python, R, Java, C++) with Python and R preferred. Familiar with machine learning tools and packages (Tensorflow, Pytorch, Scikit Learn, pandas, numpy, etc.) Experience with database systems (SQL, NoSQL) will be a plus Strong motivation with the ability to thrive in an entrepreneurial and multidisciplinary environment Ability to lead and run research projects while keep close communication wit the team Excellent communication and presentation skills to interpret computational language in a way that the stakeholders with biology/immunology background can understand What Takeda can offer you: Comprehensive Healthcare: Medical, Dental, and Vision Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs and company match of charitable contributions Family Planning Support Flexible Work Paths Tuition reimbursement More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy. Base Salary Range: $130,200.00 to $186,000.00, based on candidate professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off. The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
02/08/2023
Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda Cell Therapy Innovation (CTI) team as Senior Scientist/Principal Scientist, where you will help establish correlative analysis practice, building in-depth data analysis workflow, designing engineering biology within CTI and bridging CTI with data scientists and bioinformatician within Takeda. If you are motivated by designing complex cellular systems and distilling insight from large biological datasets, this role will be ideal for you. This is a unique opportunity to work at a start-up like culture in big pharmaceutical company to contribute to engineering biology and process biology of cell therapy product. We seek a motivated and collaborative scientist with experience applying data science and computational biology to the discovery and development of cell therapy products. Our cell therapy innovation team is focused on advancing Takeda cell therapy drug discovery through cutting-edge technologies. How you will contribute: You will lead the efforts in building correlative science and computational biology strategy in CTI working with all cross-function partners and leadership teams You will build data collection, data annotation, data cleaning and dataset compile for specific projects and downstream in-depth data correlative analysis Dive deep in high dimension NGS data using RNAseq, genome sequencing, and others to inform gene engineering biology Explore large data set of variety readouts, including immunophenotype, cell production yield and transducibility, Legend screen, cytokine profiling, function assessment etc to help with donor selection criteria set up Work with bench scientists by guiding experimental workflows and quantitative measurement to ensure statistical rigor and help building data visualization Collaborate with Precision Translational Medicine, Data Science Institute, and Data/Automation in CMC & Global Biologics to build enterprise digitization roadmap and explore new tool and technology platform Minimum Requirements/Qualifications: PhD's degree in Computer Science, bioinformatics, computational biology, system biology or other similar science and engineering disciplines, with 3+ year experience Master's degree in Computer Science, bioinformatics, computational biology, system biology or other similar science and engineering disciplines, with 7+ year experience Bachelor's degree in Computer Science, bioinformatics, computational biology, system biology or other similar science and engineering disciplines, with 10+ year experience Technical Requirements: Basic understanding of molecular biology, immunology, cell biology, and cell therapy product development Experience with at least one of the focuses: protein or DNA sequence design, natural language processing, text mining, omics data analysis (RNA seq, etc.), computer vision Expertise with many of the following areas: supervised learning, unsupervised learning, deep learning, deep generative models, transfer learning, etc. Experience working in cloud and high-performance computing environments (e.g. AWS), and experience working in a Unix/Linux environment Excellence in core machine learning languages (such as Python, R, Java, C++) with Python and R preferred. Familiar with machine learning tools and packages (Tensorflow, Pytorch, Scikit Learn, pandas, numpy, etc.) Experience with database systems (SQL, NoSQL) will be a plus Strong motivation with the ability to thrive in an entrepreneurial and multidisciplinary environment Ability to lead and run research projects while keep close communication wit the team Excellent communication and presentation skills to interpret computational language in a way that the stakeholders with biology/immunology background can understand What Takeda can offer you: Comprehensive Healthcare: Medical, Dental, and Vision Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs and company match of charitable contributions Family Planning Support Flexible Work Paths Tuition reimbursement More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy. Base Salary Range: $130,200.00 to $186,000.00, based on candidate professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off. The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as an Associate Director (AD)/Director, Global Regulatory Affairs-Oncology in our Cambridge office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an AD/Director, Global Regulatory Affairs-Oncology working on the Global Regulatory Affairs team, you will be responsible for complex or highly complex or multiple projects and lead the Global Regulatory Teams (GRTs), and a typical day will include: Objectives: Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. Is a leader both in the department and within R&D, contributing to cross-functional initiatives and influencing the field as applicable. Provides leadership and development for direct reports if applicable, including those that serve as global regulatory leads responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts. Accountabilities: The AD/Director will be responsible for complex or highly complex or multiple projects. Leads the Global Regulatory Teams (GRTs) and applicable sub-working groups, such as the Label Working Group, and represents GRTs at project team meetings. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible. Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Proactively anticipates risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions. Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports responsible. The AD/Director will lead all submission types. Direct point of contact with health authorities, leads and manages FDA meetings. Manages direct reports or junior staff as needed. Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products. Oversee vendor responsibility for regulatory activities and submissions related to projects within scope. Participates with influence in or leads departmental and cross-functional task-forces and initiatives. Lead regulatory reviewer in due diligence for licensing opportunities. Partner with global market access colleagues to Lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable. Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner. Responsible for demonstrating Takeda leadership behaviors Requirements: BSc/BA Degree, scientific discipline strongly preferred. Advanced degree in a scientific discipline (PharmD/PhD/MD) strongly preferred 8+ years of relevant scientific/pharmaceutical industry experience. Preferred experience in reviewing, authoring, or managing components of regulatory submissions. Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus. Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy. Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy. Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Must work well with others and within global teams. Able to bring working teams together for common objectives. Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Location and Salary Information: This job posting excludes CO applicants. WHAT TAKEDA CAN OFFER YOU: 401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
02/08/2023
Full time
By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as an Associate Director (AD)/Director, Global Regulatory Affairs-Oncology in our Cambridge office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an AD/Director, Global Regulatory Affairs-Oncology working on the Global Regulatory Affairs team, you will be responsible for complex or highly complex or multiple projects and lead the Global Regulatory Teams (GRTs), and a typical day will include: Objectives: Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. Is a leader both in the department and within R&D, contributing to cross-functional initiatives and influencing the field as applicable. Provides leadership and development for direct reports if applicable, including those that serve as global regulatory leads responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts. Accountabilities: The AD/Director will be responsible for complex or highly complex or multiple projects. Leads the Global Regulatory Teams (GRTs) and applicable sub-working groups, such as the Label Working Group, and represents GRTs at project team meetings. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible. Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Proactively anticipates risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions. Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports responsible. The AD/Director will lead all submission types. Direct point of contact with health authorities, leads and manages FDA meetings. Manages direct reports or junior staff as needed. Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products. Oversee vendor responsibility for regulatory activities and submissions related to projects within scope. Participates with influence in or leads departmental and cross-functional task-forces and initiatives. Lead regulatory reviewer in due diligence for licensing opportunities. Partner with global market access colleagues to Lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable. Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner. Responsible for demonstrating Takeda leadership behaviors Requirements: BSc/BA Degree, scientific discipline strongly preferred. Advanced degree in a scientific discipline (PharmD/PhD/MD) strongly preferred 8+ years of relevant scientific/pharmaceutical industry experience. Preferred experience in reviewing, authoring, or managing components of regulatory submissions. Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus. Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy. Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy. Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Must work well with others and within global teams. Able to bring working teams together for common objectives. Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Location and Salary Information: This job posting excludes CO applicants. WHAT TAKEDA CAN OFFER YOU: 401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
Principal Scientist, Analytical Development Posted: 01/04/2023 Company Overview Cerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases. We are tackling neuroscience diseases with a differentiated approach that combines expertise in neurocircuitry with a focus on receptor selectivity. Our portfolio of pre-commercial neuroscience assets targets a broad range of central nervous system (CNS) disorders, including schizophrenia, epilepsy, Parkinson's disease and substance use disorder. Headquartered in the Greater Boston area, we are bold thinkers, deep experts, resilient pathfinders, and transparent partners who push the boundaries of scientific understanding to unlock breakthrough CNS therapies that have real impact on people's lives. Cerevel aspires to develop and nurture a culture characterized by trust, respect, courage, curiosity, and compassion, with a relentless focus on mission and results. Our patient-centricity guides our purpose, how we treat each other and what we work on every day. The successful candidate will bring their own unique thinking and approach to Cerevel while sharing our core values and convictions. Role Summary Cerevel is seeking a Principal Scientist with significant experience in analytical characterization and control with an emphasis on pre-clinical to phase 2 programs to join our Analytical Development group in Cambridge, MA. The Principal Scientist will report to the Director of Analytical Development, and they will provide analytical expertise in drug substance and drug product analytical development for small molecules through pre-clinical through phase 2 development and manufacturing. They will work closely with colleagues across pharmaceutical development, medicinal chemistry, and safety assessment to best leverage Cerevel's internal development capabilities including process chemistry, analytical, and formulation development labs, instruments, and equipment. Additionally, they will identify and manage external partners for method development as well as analytical testing and characterization across Cerevel's portfolio of pre-clinical and clinical-stage programs. The Principal Scientist will grow as a subject matter expert both within and outside the department and will help drive pharmaceutical development as part of this growing, dynamic team. Key Responsibilities Provide subject matter expertise in analytical development activities at Cerevel requiring internal laboratory execution Guide and drive analytical method development, implementation as well as drug substance and drug product characterization and control for Cerevel's pre-clinical and clinical stage development programs Provide technical support and day-to-day management of out-sourced drug substance and drug product method development activities with CMO partners Manage analytical testing activities including in process, drug substance and drug product release and stability testing through review of analytical data Present technical data to cross functional teams and senior management as an expert in analytical development for Cerevel's pre-clinical and clinical-stage development programs Design, support, and analyze method transfer and validation activities across a portfolio of small molecule, solid oral dosage projects Author and review drug product and drug substance analytical sections for regulatory submissions Support any quality investigations or events and resolve them in a timely manner Train and recruit Analytical Development lab staff as needed Identify and advocate new and emerging technologies in analytical and physical characterization analysis Partner with Chemical Process Development and Formulation Development staff to assess and support drug substance and drug product characterization and retest/shelf-life setting Required Qualifications Demonstrated expertise in analytical development, method transfer, and stability program design and execution Experience with managing external testing laboratories during clinical-stage pharmaceutical development Subject matter proficiency in the analytical development of oral formulations with experience in discriminating dissolution test method development, HPLC, GC, titrations, spectroscopic methods, and physical characterization techniques such as X-ray powder diffraction, DSC, and TGA Familiarity with laboratory software and systems including, but not limited to: Open lab CDS software suite, MassHunter, and Dotmatics for Electronic Lab Notebooks (ELN) knowledge and the ability to interpret and draw conclusions from data from analytical techniques employed across drug substance and drug product development Ability to troubleshoot analytical method and testing issues, determine causes and possible solutions Proven knowledge of cGMPs and associated regulatory and quality compliance in the pharmaceutical development and manufacturing environment Experience in crystal form characterization and control Desire to work in a fast pace, dynamic environment with capability of being a CMC lead on programs Exposure to QBD principles and stability modeling techniques such as ASAP Experience in authoring and reviewing analytical components of drug substance and drug product sections of INDs as well as IMPDs A Team player capable of pushing for individual and team growth Experience managing trend analysis and supporting analytical method life-cycle management and continuous improvement Education Ph.D. (or equivalent degree) in relevant discipline and 5+years relevant work experience B.S./M.S. in relevant discipline and 10+ years relevant work experience The Company requires all employees to be vaccinated against COVID-19, including to have received a booster dose of a COVID-19 vaccine if eligible to receive one. In connection with your onboarding process, all new employees will need to provide documentary evidence of vaccination. The Company is an equal opportunity employer and will provide reasonable accommodations to those individuals who are unable to be vaccinated consistent with federal, state and local law Cerevel is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by applicable law. Open positions Cerevel is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by applicable law.
02/08/2023
Full time
Principal Scientist, Analytical Development Posted: 01/04/2023 Company Overview Cerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases. We are tackling neuroscience diseases with a differentiated approach that combines expertise in neurocircuitry with a focus on receptor selectivity. Our portfolio of pre-commercial neuroscience assets targets a broad range of central nervous system (CNS) disorders, including schizophrenia, epilepsy, Parkinson's disease and substance use disorder. Headquartered in the Greater Boston area, we are bold thinkers, deep experts, resilient pathfinders, and transparent partners who push the boundaries of scientific understanding to unlock breakthrough CNS therapies that have real impact on people's lives. Cerevel aspires to develop and nurture a culture characterized by trust, respect, courage, curiosity, and compassion, with a relentless focus on mission and results. Our patient-centricity guides our purpose, how we treat each other and what we work on every day. The successful candidate will bring their own unique thinking and approach to Cerevel while sharing our core values and convictions. Role Summary Cerevel is seeking a Principal Scientist with significant experience in analytical characterization and control with an emphasis on pre-clinical to phase 2 programs to join our Analytical Development group in Cambridge, MA. The Principal Scientist will report to the Director of Analytical Development, and they will provide analytical expertise in drug substance and drug product analytical development for small molecules through pre-clinical through phase 2 development and manufacturing. They will work closely with colleagues across pharmaceutical development, medicinal chemistry, and safety assessment to best leverage Cerevel's internal development capabilities including process chemistry, analytical, and formulation development labs, instruments, and equipment. Additionally, they will identify and manage external partners for method development as well as analytical testing and characterization across Cerevel's portfolio of pre-clinical and clinical-stage programs. The Principal Scientist will grow as a subject matter expert both within and outside the department and will help drive pharmaceutical development as part of this growing, dynamic team. Key Responsibilities Provide subject matter expertise in analytical development activities at Cerevel requiring internal laboratory execution Guide and drive analytical method development, implementation as well as drug substance and drug product characterization and control for Cerevel's pre-clinical and clinical stage development programs Provide technical support and day-to-day management of out-sourced drug substance and drug product method development activities with CMO partners Manage analytical testing activities including in process, drug substance and drug product release and stability testing through review of analytical data Present technical data to cross functional teams and senior management as an expert in analytical development for Cerevel's pre-clinical and clinical-stage development programs Design, support, and analyze method transfer and validation activities across a portfolio of small molecule, solid oral dosage projects Author and review drug product and drug substance analytical sections for regulatory submissions Support any quality investigations or events and resolve them in a timely manner Train and recruit Analytical Development lab staff as needed Identify and advocate new and emerging technologies in analytical and physical characterization analysis Partner with Chemical Process Development and Formulation Development staff to assess and support drug substance and drug product characterization and retest/shelf-life setting Required Qualifications Demonstrated expertise in analytical development, method transfer, and stability program design and execution Experience with managing external testing laboratories during clinical-stage pharmaceutical development Subject matter proficiency in the analytical development of oral formulations with experience in discriminating dissolution test method development, HPLC, GC, titrations, spectroscopic methods, and physical characterization techniques such as X-ray powder diffraction, DSC, and TGA Familiarity with laboratory software and systems including, but not limited to: Open lab CDS software suite, MassHunter, and Dotmatics for Electronic Lab Notebooks (ELN) knowledge and the ability to interpret and draw conclusions from data from analytical techniques employed across drug substance and drug product development Ability to troubleshoot analytical method and testing issues, determine causes and possible solutions Proven knowledge of cGMPs and associated regulatory and quality compliance in the pharmaceutical development and manufacturing environment Experience in crystal form characterization and control Desire to work in a fast pace, dynamic environment with capability of being a CMC lead on programs Exposure to QBD principles and stability modeling techniques such as ASAP Experience in authoring and reviewing analytical components of drug substance and drug product sections of INDs as well as IMPDs A Team player capable of pushing for individual and team growth Experience managing trend analysis and supporting analytical method life-cycle management and continuous improvement Education Ph.D. (or equivalent degree) in relevant discipline and 5+years relevant work experience B.S./M.S. in relevant discipline and 10+ years relevant work experience The Company requires all employees to be vaccinated against COVID-19, including to have received a booster dose of a COVID-19 vaccine if eligible to receive one. In connection with your onboarding process, all new employees will need to provide documentary evidence of vaccination. The Company is an equal opportunity employer and will provide reasonable accommodations to those individuals who are unable to be vaccinated consistent with federal, state and local law Cerevel is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by applicable law. Open positions Cerevel is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by applicable law.
Description Alvarez & Marsal (A&M) is a premier independent global professional services firm specializing in providing turnaround management, restructuring, performance improvement, and corporate advisory services. The Healthcare Industry Group (HIG), a subsidiary of A&M, is an established leader known for delivering tangible results for healthcare c-suite executives, boards, private equity firms, investors, law firms, and government agencies facing complex challenges. A&M's HIG practice has a deep focus on the Healthcare industry across all sectors including, Health Systems, Health Plans and Managed Care, Healthcare Services and Life Sciences, Bio-Pharmaceutical, and Medical Technology. We are at the forefront of delivering transformational change to the healthcare industry. Our professionals advise our clients on performance improvement by assessing all aspects of their operations and technology to provide comprehensive services, including conducting process reviews, analyzing financial information, identifying key business drivers, and managing risk and compliance issues. Our lean, fast-paced, and entrepreneurial culture celebrates independent thinkers and doers who can positively impact our clients while living our core values of integrity, quality, fun, objectivity, and personal reward. A&M is a firm that values results-oriented leadership and strong people skills. We put a premium on world-class individuals with the right experience who can deliver the most value. Additionally, we provide frequent opportunities to take on higher responsibility and always support employees in professional development. At A&M, you will work alongside world-class consultants and former industry executives to deliver gold standard work for our clients. A successful candidate will enjoy an environment that emphasizes entrepreneurship and minimal hierarchy and bureaucracy. The Opportunity The Technology Advisory and Transformation group in Healthcare Industry Group (HIG) is growing our practice. We are seeking individuals with top-tier consulting and healthcare industry operator experience at the Associate and Senior Associate levels. What will you be doing? As a Senior Associate or Associate, you will work closely with healthcare clients on a range of complex assignments, You will work in a team environment while using your independent judgment and critical things skills to gather data, frame situations, and provide practical solutions to add value based on clients needs. You will work with senior executive clients on business-driven technology transformations. You will work as a consultative partner to our clients you will execute day-to-day operations and relationships, ensure exceptional team performance and ensure deliverables effectively align to clients' priorities. What are we looking for? We are looking for candidates with a bias toward action and a track record of delivering meaningful results. Our ideal candidates will have: Technical Skills Understanding of technologies (digital strategy, transformation, IT infrastructure & architecture, IoT, AI/machine learning, robotics, cloud, big data and analytics, cybersecurity, blockchain, agile, and DevOps) Complex project management of technology initiatives aligned to business strategies Large transformational technology projects that resulted in a significant reduction of technology spend, improved business performance, or the introduction of new technologies and capabilities Transformation of IT operations including Leveraging as-a-service platforms, Transitioning to cloud-based infrastructures, Rationalization of applications, Automation of IT Service Management processes, Adoption of DevOps best practices Distressed technology program remediation IT merger and acquisition integration, divestiture and carve-out IT assessment and strategy development Selecting and managing third-party software, hardware, or services providers Project and Communication Skills Ability to build consensus with clients, effectively guide clients, and buy-in to support change Provide service excellence by identifying key client business issues Determine client needs by adding innovative approaches to standard assessment techniques Evaluate and validate the analysis and develop recommendations for clients Implement and oversee the quality of deliverables Participate in the development and presentation of proposals for business development Ability to handle multiple, and often conflicting, priorities at one time The high degree of professionalism and confidentiality in handling client information Strong analytical, oral, and written communication skills, including presentation skills A willingness to travel for project work depending on account and project People Skills Outstanding interpersonal skills, including the ability to work effectively in a team environment, negotiate diplomatically and maintain composure under deadline pressure Demonstrated leadership ability; Ability to work in a team-oriented environment Education & Experience A minimum of three years of prior advisory experience from a top-tier strategy firm or within management consultancy or a minimum of five-plus years of previous experience in the healthcare industry and/or a healthcare-related business including disruptive HealthTech, Government health experience like CMS, Veteran Affairs, etc. Bachelor's degree and/or Master's degree in a related field, Computer Science/Business Information Systems or business degree preferred. (Relevant Technical certification plus) How will you grow and be supported? As an Associate or Senior Associate within the Healthcare Group, you will have the opportunity to take your career to the next level by gaining invaluable industry experience while enhancing and expanding your skillsets. As a leader within our team, you will collaborate with many experienced professionals and will provide developmental feedback and growth opportunities. We work with each of our employees to develop a customized career development plan to ensure you are matched with professional development opportunities that meet your unique needs and accelerate your development. We offer a variety of live and virtual training programs, access to best-in-class on-demand training, ongoing on-the-job coaching, a transitional coach to help you acclimate to the practice, and a partnership with a mentor who will guide you through your career. Our Healthcare team prides itself on sustaining a culture that reflects our core values. We value integrity, quality, and objectivity in our work. We like what we do and with whom we do it. We embrace diversity, foster inclusiveness and reward merit. We encourage and support our employees and communities through ongoing investments from leadership, social and networking events, peer-to-peer networks, Employee Resource Groups, volunteer opportunities and pro-bono work. We are committed to promoting an inclusive environment in which all can develop, grow, and be supported. Alvarez & Marsal offers competitive benefits and opportunities to support your personal and professional development. Click to learn about our commitment to your well-being. A&M recognizes that our people drive our growth, and you will be provided with the best available training and development resources through formalized training and on-the-job training. Learn more about why A&M is a great place to work. To be considered for this position, please submit your resume. An accompanying one-page cover letter is optional should you feel it further adds to your relevant expertise, key strengths, and why working at A&M is part of your future career aspirations.
02/08/2023
Full time
Description Alvarez & Marsal (A&M) is a premier independent global professional services firm specializing in providing turnaround management, restructuring, performance improvement, and corporate advisory services. The Healthcare Industry Group (HIG), a subsidiary of A&M, is an established leader known for delivering tangible results for healthcare c-suite executives, boards, private equity firms, investors, law firms, and government agencies facing complex challenges. A&M's HIG practice has a deep focus on the Healthcare industry across all sectors including, Health Systems, Health Plans and Managed Care, Healthcare Services and Life Sciences, Bio-Pharmaceutical, and Medical Technology. We are at the forefront of delivering transformational change to the healthcare industry. Our professionals advise our clients on performance improvement by assessing all aspects of their operations and technology to provide comprehensive services, including conducting process reviews, analyzing financial information, identifying key business drivers, and managing risk and compliance issues. Our lean, fast-paced, and entrepreneurial culture celebrates independent thinkers and doers who can positively impact our clients while living our core values of integrity, quality, fun, objectivity, and personal reward. A&M is a firm that values results-oriented leadership and strong people skills. We put a premium on world-class individuals with the right experience who can deliver the most value. Additionally, we provide frequent opportunities to take on higher responsibility and always support employees in professional development. At A&M, you will work alongside world-class consultants and former industry executives to deliver gold standard work for our clients. A successful candidate will enjoy an environment that emphasizes entrepreneurship and minimal hierarchy and bureaucracy. The Opportunity The Technology Advisory and Transformation group in Healthcare Industry Group (HIG) is growing our practice. We are seeking individuals with top-tier consulting and healthcare industry operator experience at the Associate and Senior Associate levels. What will you be doing? As a Senior Associate or Associate, you will work closely with healthcare clients on a range of complex assignments, You will work in a team environment while using your independent judgment and critical things skills to gather data, frame situations, and provide practical solutions to add value based on clients needs. You will work with senior executive clients on business-driven technology transformations. You will work as a consultative partner to our clients you will execute day-to-day operations and relationships, ensure exceptional team performance and ensure deliverables effectively align to clients' priorities. What are we looking for? We are looking for candidates with a bias toward action and a track record of delivering meaningful results. Our ideal candidates will have: Technical Skills Understanding of technologies (digital strategy, transformation, IT infrastructure & architecture, IoT, AI/machine learning, robotics, cloud, big data and analytics, cybersecurity, blockchain, agile, and DevOps) Complex project management of technology initiatives aligned to business strategies Large transformational technology projects that resulted in a significant reduction of technology spend, improved business performance, or the introduction of new technologies and capabilities Transformation of IT operations including Leveraging as-a-service platforms, Transitioning to cloud-based infrastructures, Rationalization of applications, Automation of IT Service Management processes, Adoption of DevOps best practices Distressed technology program remediation IT merger and acquisition integration, divestiture and carve-out IT assessment and strategy development Selecting and managing third-party software, hardware, or services providers Project and Communication Skills Ability to build consensus with clients, effectively guide clients, and buy-in to support change Provide service excellence by identifying key client business issues Determine client needs by adding innovative approaches to standard assessment techniques Evaluate and validate the analysis and develop recommendations for clients Implement and oversee the quality of deliverables Participate in the development and presentation of proposals for business development Ability to handle multiple, and often conflicting, priorities at one time The high degree of professionalism and confidentiality in handling client information Strong analytical, oral, and written communication skills, including presentation skills A willingness to travel for project work depending on account and project People Skills Outstanding interpersonal skills, including the ability to work effectively in a team environment, negotiate diplomatically and maintain composure under deadline pressure Demonstrated leadership ability; Ability to work in a team-oriented environment Education & Experience A minimum of three years of prior advisory experience from a top-tier strategy firm or within management consultancy or a minimum of five-plus years of previous experience in the healthcare industry and/or a healthcare-related business including disruptive HealthTech, Government health experience like CMS, Veteran Affairs, etc. Bachelor's degree and/or Master's degree in a related field, Computer Science/Business Information Systems or business degree preferred. (Relevant Technical certification plus) How will you grow and be supported? As an Associate or Senior Associate within the Healthcare Group, you will have the opportunity to take your career to the next level by gaining invaluable industry experience while enhancing and expanding your skillsets. As a leader within our team, you will collaborate with many experienced professionals and will provide developmental feedback and growth opportunities. We work with each of our employees to develop a customized career development plan to ensure you are matched with professional development opportunities that meet your unique needs and accelerate your development. We offer a variety of live and virtual training programs, access to best-in-class on-demand training, ongoing on-the-job coaching, a transitional coach to help you acclimate to the practice, and a partnership with a mentor who will guide you through your career. Our Healthcare team prides itself on sustaining a culture that reflects our core values. We value integrity, quality, and objectivity in our work. We like what we do and with whom we do it. We embrace diversity, foster inclusiveness and reward merit. We encourage and support our employees and communities through ongoing investments from leadership, social and networking events, peer-to-peer networks, Employee Resource Groups, volunteer opportunities and pro-bono work. We are committed to promoting an inclusive environment in which all can develop, grow, and be supported. Alvarez & Marsal offers competitive benefits and opportunities to support your personal and professional development. Click to learn about our commitment to your well-being. A&M recognizes that our people drive our growth, and you will be provided with the best available training and development resources through formalized training and on-the-job training. Learn more about why A&M is a great place to work. To be considered for this position, please submit your resume. An accompanying one-page cover letter is optional should you feel it further adds to your relevant expertise, key strengths, and why working at A&M is part of your future career aspirations.
Job Description: The Role As a Senior Copywriter for our new Digital Content Delivery team, you ll help us re-invent and modernize the way we produce financial education content. A strong digital storyteller, you'll work together with content creators, art directors, producers and other partners to concept and craft platform-first video and content for social media, tapping into trends to increase engagement, follows and conversations. Through compelling storytelling, you'll get our followers to stop, smile, engage and share and above all, think about Fidelity in a brand-new way. The Expertise and Skills You Bring 3-5 years relevant copywriting experience at an agency or in-house for major brand(s) Experience writing and developing copy for platforms including, but not limited to: Instagram, Twitter, Facebook, TikTok, LinkedIn, Reddit, Discord, and Pinterest Curiosity about and knowledge of emerging cultural and social trends Understanding of strong narrative storytelling, particularly for short-form, social content Ability to research topics, find strong story threads and cull sources Appreciates the diverse audiences on social, podcast listeners, and the unique needs of those audiences Confidence to present ideas (including the wild ones) to your peers and senior leaders An ability to have fun while working hard in a fast paced, agile environment Portfolio required for consideration. Financial Services experience a plus but not required. The Team As Senior Copywriter, you will play a meaningful role in evolving what it takes to successfully engage customers through video, audio and design content in a platform-first approach. As part of a new team, you will have a stake in crafting workflow and innovation. The team is on the front lines with our customers. Together, we help educate and inspire best-in-class end-to-end experiences across all our programming. We amplify Fidelity s thought leadership and engage with unique content, marketed across communication channels. We innovate through testing and experimentation. We learn from failures and celebrate successes, together. Certifications: Company Overview Fidelity Investments is a privately held company with a mission to strengthen the financial well-being of our clients. We help people invest and plan for their future. We assist companies and non-profit organizations in delivering benefits to their employees. And we provide institutions and independent advisors with investment and technology solutions to help invest their own clients' money. Join Us At Fidelity, you'll find endless opportunities to build a meaningful career that positively impacts peoples' lives, including yours. You can take advantage of flexible benefits that support you through every stage of your career, empowering you to thrive at work and at home. Honored with a Glassdoor Employees' Choice Award , we have been recognized by our employees as a Best Place to Work in 2023. And you don't need a finance background to succeed at Fidelity-we offer a range of opportunities for learning so you can build the career you've always imagined. At Fidelity, our goal is for most people to work flexibly in a way that balances both personal and business needs with time onsite and offsite through what we're calling " Dynamic Working ." We invite you to Find Your Fidelity at . Fidelity Investments is an equal opportunity employer. We believe that the most effective way to attract, develop and retain a diverse workforce is to build an enduring culture of inclusion and belonging. Fidelity will reasonably accommodate applicants with disabilities who need adjustments to participate in the application or interview process. To initiate a request for an accommodation, contact the HR Accommodation Team by sending an email to , or by calling , prompt 2, option 3.
02/08/2023
Full time
Job Description: The Role As a Senior Copywriter for our new Digital Content Delivery team, you ll help us re-invent and modernize the way we produce financial education content. A strong digital storyteller, you'll work together with content creators, art directors, producers and other partners to concept and craft platform-first video and content for social media, tapping into trends to increase engagement, follows and conversations. Through compelling storytelling, you'll get our followers to stop, smile, engage and share and above all, think about Fidelity in a brand-new way. The Expertise and Skills You Bring 3-5 years relevant copywriting experience at an agency or in-house for major brand(s) Experience writing and developing copy for platforms including, but not limited to: Instagram, Twitter, Facebook, TikTok, LinkedIn, Reddit, Discord, and Pinterest Curiosity about and knowledge of emerging cultural and social trends Understanding of strong narrative storytelling, particularly for short-form, social content Ability to research topics, find strong story threads and cull sources Appreciates the diverse audiences on social, podcast listeners, and the unique needs of those audiences Confidence to present ideas (including the wild ones) to your peers and senior leaders An ability to have fun while working hard in a fast paced, agile environment Portfolio required for consideration. Financial Services experience a plus but not required. The Team As Senior Copywriter, you will play a meaningful role in evolving what it takes to successfully engage customers through video, audio and design content in a platform-first approach. As part of a new team, you will have a stake in crafting workflow and innovation. The team is on the front lines with our customers. Together, we help educate and inspire best-in-class end-to-end experiences across all our programming. We amplify Fidelity s thought leadership and engage with unique content, marketed across communication channels. We innovate through testing and experimentation. We learn from failures and celebrate successes, together. Certifications: Company Overview Fidelity Investments is a privately held company with a mission to strengthen the financial well-being of our clients. We help people invest and plan for their future. We assist companies and non-profit organizations in delivering benefits to their employees. And we provide institutions and independent advisors with investment and technology solutions to help invest their own clients' money. Join Us At Fidelity, you'll find endless opportunities to build a meaningful career that positively impacts peoples' lives, including yours. You can take advantage of flexible benefits that support you through every stage of your career, empowering you to thrive at work and at home. Honored with a Glassdoor Employees' Choice Award , we have been recognized by our employees as a Best Place to Work in 2023. And you don't need a finance background to succeed at Fidelity-we offer a range of opportunities for learning so you can build the career you've always imagined. At Fidelity, our goal is for most people to work flexibly in a way that balances both personal and business needs with time onsite and offsite through what we're calling " Dynamic Working ." We invite you to Find Your Fidelity at . Fidelity Investments is an equal opportunity employer. We believe that the most effective way to attract, develop and retain a diverse workforce is to build an enduring culture of inclusion and belonging. Fidelity will reasonably accommodate applicants with disabilities who need adjustments to participate in the application or interview process. To initiate a request for an accommodation, contact the HR Accommodation Team by sending an email to , or by calling , prompt 2, option 3.
We are recruiting for Pension Associate Actuarial Consultants to join our Retirement Practice. We offer a position that involves a diverse range of responsibilities that include producing and reviewing actuarial work product, managing projects, mentoring/guiding others, providing technical support on complex client projects and related actuarial issues. The Pension Associate Actuarial Consultant will provide a level of review, actuarial services, and consulting expertise to pension clients (valuations and reports, special projects and other relevant consulting projects for clients predominantly multiemployer pension plans). Key aspects of the position include: • Provide a level of review to valuation reports and actuarial projects to ensure high quality client deliverables. • Provide technical guidance to and mentoring junior colleagues and serving as a technical resource. • Present at client meetings and participate on special projects designed to address emerging and/or unique retirement issues posed by client organizations. This is a hybrid position with locations in Atlanta, Boston, DC and Hartford. Competent understanding of actuarial concepts, methods, and applications and the ability to apply this knowledge in a variety of problem-solving situations. Five years of pension actuarial experience to include working in an employee benefits consulting environment. At least four actuarial exams passed with active progression to credentialed status (ASA preferred). Strong client service skills and technical expertise. A big picture perspective to understanding, defining and responding to client needs. The ability to develop and gain support for recommendations in response to complex issues. Excellent communication (verbal/written) and interpersonal skills with ability to interact effectively with diverse and sophisticated audiences. Diversity, Equity & Inclusion at Segal We recognize that individuals bring a broad range of experience and abilities that go beyond the technical requirements of a job. If your experience and qualifications are close to what you see described here, we encourage you to apply. Diversity of employment, skills and life experience, combined with passion, are key to innovation and excellence. We encourage individuals, including but not limited to women, minorities, the disabled and protected veterans and those from all other backgrounds to apply to our positions. Please let us know if you require accommodation during the interview process and thank you for considering Segal. About Segal and its Total Rewards Program: Segal is a privately owned, leading North American employee benefit, human resources and investment management consulting firm with over 80 years of history providing trusted advice that improves lives. Clients include public and private corporations, multiemployer trust funds, public sector entities, higher education institutions, institutional advisors, among many others. Segal's total rewards are part of what makes Segal a special place to work. The current salary range for this position is $69,000 to $100,000 plus opportunity for a discretionary performance bonus based on company profitability and employee performance. In addition, Segal offers a comprehensive suite of benefits to include a non-contributory defined benefit pension plan, matching and discretionary contributions to a 401(k) profit sharing plan, medical and prescription benefits including contributions to a health savings account for eligible employees, dental benefits, life insurance, disability insurance, an Employee Assistance Program, wellness benefit reimbursements and rewards, and professional credential and tuition reimbursement. Segal also provides comprehensive paid time off including holidays, vacation days, sick leave, paid family leave and sabbaticals. Please Apply Competent understanding of actuarial concepts, methods, and applications and the ability to apply this knowledge in a variety of problem-solving situations. Five years of pension actuarial experience to include working in an employee benefits consulting environment. At least four actuarial exams passed with active progression to credentialed status (ASA preferred). Strong client service skills and technical expertise. A big picture perspective to understanding, defining and responding to client needs. The ability to develop and gain support for recommendations in response to complex issues. Excellent communication (verbal/written) and interpersonal skills with ability to interact effectively with diverse and sophisticated audiences. Diversity, Equity & Inclusion at Segal We recognize that individuals bring a broad range of experience and abilities that go beyond the technical requirements of a job. If your experience and qualifications are close to what you see described here, we encourage you to apply. Diversity of employment, skills and life experience, combined with passion, are key to innovation and excellence. We encourage individuals, including but not limited to women, minorities, the disabled and protected veterans and those from all other backgrounds to apply to our positions. Please let us know if you require accommodation during the interview process and thank you for considering Segal. About Segal and its Total Rewards Program: Segal is a privately owned, leading North American employee benefit, human resources and investment management consulting firm with over 80 years of history providing trusted advice that improves lives. Clients include public and private corporations, multiemployer trust funds, public sector entities, higher education institutions, institutional advisors, among many others. Segal's total rewards are part of what makes Segal a special place to work. The current salary range for this position is $69,000 to $100,000 plus opportunity for a discretionary performance bonus based on company profitability and employee performance. In addition, Segal offers a comprehensive suite of benefits to include a non-contributory defined benefit pension plan, matching and discretionary contributions to a 401(k) profit sharing plan, medical and prescription benefits including contributions to a health savings account for eligible employees, dental benefits, life insurance, disability insurance, an Employee Assistance Program, wellness benefit reimbursements and rewards, and professional credential and tuition reimbursement. Segal also provides comprehensive paid time off including holidays, vacation days, sick leave, paid family leave and sabbaticals. Please Apply Segal is the right size, the right organization and the right move for you! Please apply now. Primary Location: US-DC-Washington Work Locations: Washington DC (12) 1800 M Street NW, Suite 900 S Washington, 20036 Boston (15) 116 Huntington Avenue, Suite 901 Boston, 02116 Hartford (17) 30 Waterside Drive, Suite 300 Farmington, 06032 Atlanta (16) 2727 Paces Ferry Rd SE, Bldg. 1, Ste 1400 Atlanta, 30339 Job: Consulting - Actuarial Organization: East Schedule: Regular Employee Employee Status: Experienced Level Job Type: Full-time Travel: Yes, 10 % of the Time Job Posting: Nov 1, 2022, 7:48:03 AM
02/08/2023
Full time
We are recruiting for Pension Associate Actuarial Consultants to join our Retirement Practice. We offer a position that involves a diverse range of responsibilities that include producing and reviewing actuarial work product, managing projects, mentoring/guiding others, providing technical support on complex client projects and related actuarial issues. The Pension Associate Actuarial Consultant will provide a level of review, actuarial services, and consulting expertise to pension clients (valuations and reports, special projects and other relevant consulting projects for clients predominantly multiemployer pension plans). Key aspects of the position include: • Provide a level of review to valuation reports and actuarial projects to ensure high quality client deliverables. • Provide technical guidance to and mentoring junior colleagues and serving as a technical resource. • Present at client meetings and participate on special projects designed to address emerging and/or unique retirement issues posed by client organizations. This is a hybrid position with locations in Atlanta, Boston, DC and Hartford. Competent understanding of actuarial concepts, methods, and applications and the ability to apply this knowledge in a variety of problem-solving situations. Five years of pension actuarial experience to include working in an employee benefits consulting environment. At least four actuarial exams passed with active progression to credentialed status (ASA preferred). Strong client service skills and technical expertise. A big picture perspective to understanding, defining and responding to client needs. The ability to develop and gain support for recommendations in response to complex issues. Excellent communication (verbal/written) and interpersonal skills with ability to interact effectively with diverse and sophisticated audiences. Diversity, Equity & Inclusion at Segal We recognize that individuals bring a broad range of experience and abilities that go beyond the technical requirements of a job. If your experience and qualifications are close to what you see described here, we encourage you to apply. Diversity of employment, skills and life experience, combined with passion, are key to innovation and excellence. We encourage individuals, including but not limited to women, minorities, the disabled and protected veterans and those from all other backgrounds to apply to our positions. Please let us know if you require accommodation during the interview process and thank you for considering Segal. About Segal and its Total Rewards Program: Segal is a privately owned, leading North American employee benefit, human resources and investment management consulting firm with over 80 years of history providing trusted advice that improves lives. Clients include public and private corporations, multiemployer trust funds, public sector entities, higher education institutions, institutional advisors, among many others. Segal's total rewards are part of what makes Segal a special place to work. The current salary range for this position is $69,000 to $100,000 plus opportunity for a discretionary performance bonus based on company profitability and employee performance. In addition, Segal offers a comprehensive suite of benefits to include a non-contributory defined benefit pension plan, matching and discretionary contributions to a 401(k) profit sharing plan, medical and prescription benefits including contributions to a health savings account for eligible employees, dental benefits, life insurance, disability insurance, an Employee Assistance Program, wellness benefit reimbursements and rewards, and professional credential and tuition reimbursement. Segal also provides comprehensive paid time off including holidays, vacation days, sick leave, paid family leave and sabbaticals. Please Apply Competent understanding of actuarial concepts, methods, and applications and the ability to apply this knowledge in a variety of problem-solving situations. Five years of pension actuarial experience to include working in an employee benefits consulting environment. At least four actuarial exams passed with active progression to credentialed status (ASA preferred). Strong client service skills and technical expertise. A big picture perspective to understanding, defining and responding to client needs. The ability to develop and gain support for recommendations in response to complex issues. Excellent communication (verbal/written) and interpersonal skills with ability to interact effectively with diverse and sophisticated audiences. Diversity, Equity & Inclusion at Segal We recognize that individuals bring a broad range of experience and abilities that go beyond the technical requirements of a job. If your experience and qualifications are close to what you see described here, we encourage you to apply. Diversity of employment, skills and life experience, combined with passion, are key to innovation and excellence. We encourage individuals, including but not limited to women, minorities, the disabled and protected veterans and those from all other backgrounds to apply to our positions. Please let us know if you require accommodation during the interview process and thank you for considering Segal. About Segal and its Total Rewards Program: Segal is a privately owned, leading North American employee benefit, human resources and investment management consulting firm with over 80 years of history providing trusted advice that improves lives. Clients include public and private corporations, multiemployer trust funds, public sector entities, higher education institutions, institutional advisors, among many others. Segal's total rewards are part of what makes Segal a special place to work. The current salary range for this position is $69,000 to $100,000 plus opportunity for a discretionary performance bonus based on company profitability and employee performance. In addition, Segal offers a comprehensive suite of benefits to include a non-contributory defined benefit pension plan, matching and discretionary contributions to a 401(k) profit sharing plan, medical and prescription benefits including contributions to a health savings account for eligible employees, dental benefits, life insurance, disability insurance, an Employee Assistance Program, wellness benefit reimbursements and rewards, and professional credential and tuition reimbursement. Segal also provides comprehensive paid time off including holidays, vacation days, sick leave, paid family leave and sabbaticals. Please Apply Segal is the right size, the right organization and the right move for you! Please apply now. Primary Location: US-DC-Washington Work Locations: Washington DC (12) 1800 M Street NW, Suite 900 S Washington, 20036 Boston (15) 116 Huntington Avenue, Suite 901 Boston, 02116 Hartford (17) 30 Waterside Drive, Suite 300 Farmington, 06032 Atlanta (16) 2727 Paces Ferry Rd SE, Bldg. 1, Ste 1400 Atlanta, 30339 Job: Consulting - Actuarial Organization: East Schedule: Regular Employee Employee Status: Experienced Level Job Type: Full-time Travel: Yes, 10 % of the Time Job Posting: Nov 1, 2022, 7:48:03 AM
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Process Chemistry Development (PCD) is responsible for the development of robust, sustainable, and cost-effective processes for the manufacture of new synthetic molecule pharmaceuticals, along with methods for achieving and controlling high standards of purity and quality. Our team is looking for a highly motivated individual ready to join our Cambridge-based team of Process Chemists and Engineers as we seek to discover innovative solutions to manufacturing challenges. As a Associate Scientific Fellow / Senior Scientist, Drug Substance Program Lead, Process Chemistry Development within PCD, you will be a recognized technical leader and will possess a deep knowledge of process chemistry development for synthetic molecules. You will be key to driving advancement of the technical aspects of the portfolio by developing and executing on complex scientific strategies, overseeing internal and external efforts and potentially leveraging personal laboratory effort as well. You will have full accountability for all technical chemistry aspects for one or more pipeline projects and will lead/participate in multidisciplinary technical teams. You will promote the department through driving strategic thinking and will be empowered to push the boundaries of synthetic chemistry to innovate in drug development. How you will contribute: Develop project technical strategy and leverage technical skill(s) as a resource/expert within the department. Make significant independent contributions to complex/multiple projects or functional areas through leading or influencing others. You will have full accountability for all chemistry aspects for one or more pipeline projects and will be responsible for managing key vendor relationships across said projects. Will be responsible for preparing and coordinating completion of technology transfer documentation, CMC sections of regulatory documents, validation plans and reports within expertise for review. Leverage cross functional knowledge to guide pharmaceutical sciences teams on potential impact of actions across projects, particularly in regard to technical and strategic aspects of drug development. Contribute significantly to develop, drive and set vision and direction of departmental scientific and strategic initiatives. Identify topics for initiatives and lead local/global initiatives on behalf of senior staff. May have direct reports. Minimum Requirements/Qualifications: A Ph.D. degree with 3+ years (7+ for ASF) pharmaceutical industry experience; an MS degree with 9+ years (13+ for ASF) of pharmaceutical industry experience; or a BS degree with 11+ years (15+ for ASF) of pharmaceutical industry experience. Extensive experience in synthetic organic chemistry and in process development of synthetic small molecules. Experience as a project leader for synthetic molecule process discovery and development. Sound knowledge of current Good Manufacturing Practices (cGMP). Experience authoring CMC sections of regulatory documents is a plus. Experience working cross-functionally with Process Engineering is a plus. Previous experience with the use of contract facilities and managing technical transfers is a plus. Experience introducing novel synthetic/manufacturing technologies into a GMP setting is a plus. Experience in working in a multi-disciplinary team environment. Significant technical and strategic leadership and accomplishment Familiarity with the use of process analytical technologies (FT-IR, NIR, FBRM, UV-vis, etc.). May require approximately 10% travel. What Takeda can offer you: Comprehensive Healthcare: Medical, Dental, and Vision Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs and company match of charitable contributions Family Planning Support Flexible Work Paths Tuition reimbursement More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
02/08/2023
Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Process Chemistry Development (PCD) is responsible for the development of robust, sustainable, and cost-effective processes for the manufacture of new synthetic molecule pharmaceuticals, along with methods for achieving and controlling high standards of purity and quality. Our team is looking for a highly motivated individual ready to join our Cambridge-based team of Process Chemists and Engineers as we seek to discover innovative solutions to manufacturing challenges. As a Associate Scientific Fellow / Senior Scientist, Drug Substance Program Lead, Process Chemistry Development within PCD, you will be a recognized technical leader and will possess a deep knowledge of process chemistry development for synthetic molecules. You will be key to driving advancement of the technical aspects of the portfolio by developing and executing on complex scientific strategies, overseeing internal and external efforts and potentially leveraging personal laboratory effort as well. You will have full accountability for all technical chemistry aspects for one or more pipeline projects and will lead/participate in multidisciplinary technical teams. You will promote the department through driving strategic thinking and will be empowered to push the boundaries of synthetic chemistry to innovate in drug development. How you will contribute: Develop project technical strategy and leverage technical skill(s) as a resource/expert within the department. Make significant independent contributions to complex/multiple projects or functional areas through leading or influencing others. You will have full accountability for all chemistry aspects for one or more pipeline projects and will be responsible for managing key vendor relationships across said projects. Will be responsible for preparing and coordinating completion of technology transfer documentation, CMC sections of regulatory documents, validation plans and reports within expertise for review. Leverage cross functional knowledge to guide pharmaceutical sciences teams on potential impact of actions across projects, particularly in regard to technical and strategic aspects of drug development. Contribute significantly to develop, drive and set vision and direction of departmental scientific and strategic initiatives. Identify topics for initiatives and lead local/global initiatives on behalf of senior staff. May have direct reports. Minimum Requirements/Qualifications: A Ph.D. degree with 3+ years (7+ for ASF) pharmaceutical industry experience; an MS degree with 9+ years (13+ for ASF) of pharmaceutical industry experience; or a BS degree with 11+ years (15+ for ASF) of pharmaceutical industry experience. Extensive experience in synthetic organic chemistry and in process development of synthetic small molecules. Experience as a project leader for synthetic molecule process discovery and development. Sound knowledge of current Good Manufacturing Practices (cGMP). Experience authoring CMC sections of regulatory documents is a plus. Experience working cross-functionally with Process Engineering is a plus. Previous experience with the use of contract facilities and managing technical transfers is a plus. Experience introducing novel synthetic/manufacturing technologies into a GMP setting is a plus. Experience in working in a multi-disciplinary team environment. Significant technical and strategic leadership and accomplishment Familiarity with the use of process analytical technologies (FT-IR, NIR, FBRM, UV-vis, etc.). May require approximately 10% travel. What Takeda can offer you: Comprehensive Healthcare: Medical, Dental, and Vision Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs and company match of charitable contributions Family Planning Support Flexible Work Paths Tuition reimbursement More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description LOCATION: Hybrid - Cambridge MA - expectation to be local or relocate to the Cambridge area to be in the office 2-3 days per week. OBJECTIVES/PURPOSE As the Sr. Director, Clinical Data Management you will report to the Head, Clinical Data Management. You will be responsible for the effective leadership, strategic planning, and oversight for one or several Therapeutic Area Units (TAUs) and/or operational units within Clinical Data Management (CDM). You will sets the vision, direction, and strategy for area(s) of responsibility and actively contributes to and aligns with the overall CDM, Innovation & Data (I&D) and Global Development Office (GDO) strategies and operating models. Leads operationalization activities to ensure on time, high quality and within budget delivery that enable successful trial data analyses for Takeda to deliver medicines to patients faster. ACCOUNTABILITIES Responsible for the timely and high quality delivery of clinical databases for assigned TAUs, ensuring fitness of purpose and compliance to applicable regulations and SOPs. Drives quality, efficiency, and innovation to ensure data management deliverables are met within the established timelines, budget, and applicable standards. Lead the development of robust strategies for DM resourcing, outsourcing, technologies and risk management to enable more efficient management, collaboration, and pro-active decision making. Contribute to the overall strategic direction of Takeda R&D and the role of clinical data management in maintaining the company's competitive advantage and delivering on Takeda's business objectives. Support the Head of Clinical Data Management in leading cross-functional efforts to build out processes and infrastructure necessary to internalize key CDM capabilities and optimize overall operational delivery. Represents CDM on key cross-functional initiatives. Drive significant levels of business change, within CDM and across the broader organization to ensure the successful execution of the CDM strategy and operating models. Champion harmonization efforts across regions, TAUs and service providers. Recruit, selects, develops, manages, motivates, coaches and appraises the performance of direct reports. Builds team commitment to goals, and creates a positive and productive culture within the team. Ensures appropriate training and acts as a leader and mentor for all DM globally. Lead the development of SOPs, procedural documentation and continuous process improvement activities in collaboration with DM leadership team. Identifies areas for simplification and innovation as well as new and emerging enabling technologies. Represent CDM in global regulatory audits and inspections and ensure successful outcomes in line with business expectations. Establish, foster and enhance relationships within and across the global organization as well as with service providers. EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: Bachelor's/MS Degree or international equivalent preferred, or equivalent combination of education, training and experience Degree with a minimum of 15 plus years of experience or equivalency of 20 plus years experience in lieu of degree 7+ years of line management experience with prior second-level management experience required. Experience managing operational vendor relationships and alliance partnerships at a program or portfolio level. Project management experience managing data management activities for large drug development programs. Experience working on Phase I-IV studies across multiple therapeutic areas and programs, and be capable of leading DM activities to support regulatory submissions and inspections. Excellent verbal/written communication skills and ability to influence at all levels across functions and build effective relationships. Seasoned leader with a passion for people development and an ability perform in a highly dynamic environment. Base Salary Range: $194,600 to $278,000. Employees may also be eligible for Short Term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off. The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
02/08/2023
Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description LOCATION: Hybrid - Cambridge MA - expectation to be local or relocate to the Cambridge area to be in the office 2-3 days per week. OBJECTIVES/PURPOSE As the Sr. Director, Clinical Data Management you will report to the Head, Clinical Data Management. You will be responsible for the effective leadership, strategic planning, and oversight for one or several Therapeutic Area Units (TAUs) and/or operational units within Clinical Data Management (CDM). You will sets the vision, direction, and strategy for area(s) of responsibility and actively contributes to and aligns with the overall CDM, Innovation & Data (I&D) and Global Development Office (GDO) strategies and operating models. Leads operationalization activities to ensure on time, high quality and within budget delivery that enable successful trial data analyses for Takeda to deliver medicines to patients faster. ACCOUNTABILITIES Responsible for the timely and high quality delivery of clinical databases for assigned TAUs, ensuring fitness of purpose and compliance to applicable regulations and SOPs. Drives quality, efficiency, and innovation to ensure data management deliverables are met within the established timelines, budget, and applicable standards. Lead the development of robust strategies for DM resourcing, outsourcing, technologies and risk management to enable more efficient management, collaboration, and pro-active decision making. Contribute to the overall strategic direction of Takeda R&D and the role of clinical data management in maintaining the company's competitive advantage and delivering on Takeda's business objectives. Support the Head of Clinical Data Management in leading cross-functional efforts to build out processes and infrastructure necessary to internalize key CDM capabilities and optimize overall operational delivery. Represents CDM on key cross-functional initiatives. Drive significant levels of business change, within CDM and across the broader organization to ensure the successful execution of the CDM strategy and operating models. Champion harmonization efforts across regions, TAUs and service providers. Recruit, selects, develops, manages, motivates, coaches and appraises the performance of direct reports. Builds team commitment to goals, and creates a positive and productive culture within the team. Ensures appropriate training and acts as a leader and mentor for all DM globally. Lead the development of SOPs, procedural documentation and continuous process improvement activities in collaboration with DM leadership team. Identifies areas for simplification and innovation as well as new and emerging enabling technologies. Represent CDM in global regulatory audits and inspections and ensure successful outcomes in line with business expectations. Establish, foster and enhance relationships within and across the global organization as well as with service providers. EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: Bachelor's/MS Degree or international equivalent preferred, or equivalent combination of education, training and experience Degree with a minimum of 15 plus years of experience or equivalency of 20 plus years experience in lieu of degree 7+ years of line management experience with prior second-level management experience required. Experience managing operational vendor relationships and alliance partnerships at a program or portfolio level. Project management experience managing data management activities for large drug development programs. Experience working on Phase I-IV studies across multiple therapeutic areas and programs, and be capable of leading DM activities to support regulatory submissions and inspections. Excellent verbal/written communication skills and ability to influence at all levels across functions and build effective relationships. Seasoned leader with a passion for people development and an ability perform in a highly dynamic environment. Base Salary Range: $194,600 to $278,000. Employees may also be eligible for Short Term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off. The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Takeda Development Center Americas is seeking an Assoc. Director, Global Regulatory Affairs Marketed Products in Cambridge, MA with the following requirements: Bachelor's degree in a Scientific Discipline and 8 years related experience. Prior experience must include at least 6 years of experience with each of the following: Apply FDA, EMA and Health Canada regulations to design and execute regulatory strategies to maintain registration and ensure global regulatory compliance; plan and manage regulatory submissions for global submissions considering company goals, procedural timelines and regulations for life cycle management; lead regulatory strategies, chair meetings and negotiate favorable outcomes with FDA. Travel required up to 30% of time. May work from home 20-75%; must live within commuting distance of office. Apply on-line at and search for Req # R EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
02/08/2023
Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Takeda Development Center Americas is seeking an Assoc. Director, Global Regulatory Affairs Marketed Products in Cambridge, MA with the following requirements: Bachelor's degree in a Scientific Discipline and 8 years related experience. Prior experience must include at least 6 years of experience with each of the following: Apply FDA, EMA and Health Canada regulations to design and execute regulatory strategies to maintain registration and ensure global regulatory compliance; plan and manage regulatory submissions for global submissions considering company goals, procedural timelines and regulations for life cycle management; lead regulatory strategies, chair meetings and negotiate favorable outcomes with FDA. Travel required up to 30% of time. May work from home 20-75%; must live within commuting distance of office. Apply on-line at and search for Req # R EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
Chief, Spine Section New England Baptist Hospital Boston, MA The Opportunity: New England Baptist Hospital (NEBH), part of Beth Israel Lahey Health, is seeking applications and nominations for the position of Chief, Spine Section. NEBH is the premier regional provider for orthopedic surgery and the treatment of musculoskeletal diseases and disorders. This is a unique opportunity to lead and support a group of surgeons, primarily private practice, that specialize in all areas of spine surgery including degenerative and major deformity. The Position: NEBH is seeking an established leader in spine surgery with a record of excellence in clinical outcomes, education, and research. The new Chief, Spine section will report directly to the Clinical Chair of Orthopedics and Surgeon-in-Chief, Dr. David Mattingly, and will work closely with David Passafaro, NEBH President. The Chief will have responsibility of coordinating all planning, medical staff supervision and hospital management interface for the Spine Section in addition to maintaining a clinical practice. The leader will oversee activities of the residents and fellows as well as work with the Fellowship Director on the Fellowship application and recruitment process. The Chief will be instrumental in starting the foundational work to develop a center of excellence for spine surgery at NEBH for the entire BILH system. The Ideal Candidate: MD or equivalent with residency training in Orthopedic Surgery or Neurosurgery and completion of a spine fellowship. American Board Certification by the American Board of Orthopaedic Surgery (ABOS) or American Board of Neurological Surgery (ABNS). Must have or be able to obtain an unrestricted medical license in the Commonwealth of Massachusetts. Strong record of clinical excellence and accomplishments in the field of spine surgery. Leadership skills commensurate with a history of leadership roles/responsibilities and an understanding of behavioral and organizational change methodology is preferred. Strong history of working effectively with physicians to bring about change and innovation. Strong management skills, including managing and mentoring staff, building organizational capability, and collaborating effectively with peers. Ability to drive recruitment of additional spine surgeons to the section and lead diversity, equity and inclusion efforts across the Spine Section and in the recruitment of new team members. Ability to mobilize and engage stakeholders outside of their span of control. Experience and/or understanding of private practice. Demonstrated ability to quickly gain traction in new settings and adapt to changing priorities. Demonstrated ability to recruit, retain, mentor, and inspire a diverse group of physicians which are primarily private practice. Outgoing, collaborative approach that fosters relationship-building and cooperation; highly effective facilitation skills. Works well in a team environment; track record of developing effective and trusted relationships at all levels of the organization; proven ability to guide teams based on compelling vision and fact-based analysis across multiple dimensions. Excellent understanding of finances and budgets; demonstrated experience in fiscal management. The Organization: New England Baptist Hospital is an affiliate of Tufts University School of Medicine, conducting teaching programs in collaboration with Harvard Medical School. NEBH is recognized as the preferred destination for musculoskeletal care and leads the region as the most trusted source for care and education for patients with musculoskeletal disease and related disorders. Through clinical excellence, innovation, scholarship, efficiency, and legendary service to their patients, NEBH has earned a leadership position among the nation's top hospitals and has consistently ranked as one of America's top hospitals for orthopedics by U.S. News and World Report . NEBH has also earned The Joint Commission's Gold Seal of Approval for Advanced Certification for Total Hip and Total Knee Replacement and for Advanced Disease Specific Care for Spine Surgery. NEBH is one of only four hospitals in the nation to earn certification for Advanced Disease Specific Care for Spine Surgery. Beginning March 2019, Beth Israel Lahey Health officially embarked on a journey to transform healthcare in Massachusetts. Formed through the merger of Beth Israel Deaconess Medical Center, Lahey Health, New England Baptist Hospital, Mount Auburn Hospital, and Anna Jaques Hospital, BILH is now the second largest health system in Massachusetts with 13 hospitals. The Location: Boston is one of the most attractive locations in all of New England, with notable, professional sports teams, excellent restaurants, and an abundance of cultural attractions and sights. Its historical buildings, world-class museums, parks, and cemeteries are national landmarks, and the city boasts the birthplaces of many famous patriots, presidents, and politicians. It is the leading center of higher education in the United States. More than 200,000 students are drawn to more than two dozen universities in Boston and the surrounding communities. Please direct all inquiries, applications, and referrals to: Heather Van Hecke
02/08/2023
Full time
Chief, Spine Section New England Baptist Hospital Boston, MA The Opportunity: New England Baptist Hospital (NEBH), part of Beth Israel Lahey Health, is seeking applications and nominations for the position of Chief, Spine Section. NEBH is the premier regional provider for orthopedic surgery and the treatment of musculoskeletal diseases and disorders. This is a unique opportunity to lead and support a group of surgeons, primarily private practice, that specialize in all areas of spine surgery including degenerative and major deformity. The Position: NEBH is seeking an established leader in spine surgery with a record of excellence in clinical outcomes, education, and research. The new Chief, Spine section will report directly to the Clinical Chair of Orthopedics and Surgeon-in-Chief, Dr. David Mattingly, and will work closely with David Passafaro, NEBH President. The Chief will have responsibility of coordinating all planning, medical staff supervision and hospital management interface for the Spine Section in addition to maintaining a clinical practice. The leader will oversee activities of the residents and fellows as well as work with the Fellowship Director on the Fellowship application and recruitment process. The Chief will be instrumental in starting the foundational work to develop a center of excellence for spine surgery at NEBH for the entire BILH system. The Ideal Candidate: MD or equivalent with residency training in Orthopedic Surgery or Neurosurgery and completion of a spine fellowship. American Board Certification by the American Board of Orthopaedic Surgery (ABOS) or American Board of Neurological Surgery (ABNS). Must have or be able to obtain an unrestricted medical license in the Commonwealth of Massachusetts. Strong record of clinical excellence and accomplishments in the field of spine surgery. Leadership skills commensurate with a history of leadership roles/responsibilities and an understanding of behavioral and organizational change methodology is preferred. Strong history of working effectively with physicians to bring about change and innovation. Strong management skills, including managing and mentoring staff, building organizational capability, and collaborating effectively with peers. Ability to drive recruitment of additional spine surgeons to the section and lead diversity, equity and inclusion efforts across the Spine Section and in the recruitment of new team members. Ability to mobilize and engage stakeholders outside of their span of control. Experience and/or understanding of private practice. Demonstrated ability to quickly gain traction in new settings and adapt to changing priorities. Demonstrated ability to recruit, retain, mentor, and inspire a diverse group of physicians which are primarily private practice. Outgoing, collaborative approach that fosters relationship-building and cooperation; highly effective facilitation skills. Works well in a team environment; track record of developing effective and trusted relationships at all levels of the organization; proven ability to guide teams based on compelling vision and fact-based analysis across multiple dimensions. Excellent understanding of finances and budgets; demonstrated experience in fiscal management. The Organization: New England Baptist Hospital is an affiliate of Tufts University School of Medicine, conducting teaching programs in collaboration with Harvard Medical School. NEBH is recognized as the preferred destination for musculoskeletal care and leads the region as the most trusted source for care and education for patients with musculoskeletal disease and related disorders. Through clinical excellence, innovation, scholarship, efficiency, and legendary service to their patients, NEBH has earned a leadership position among the nation's top hospitals and has consistently ranked as one of America's top hospitals for orthopedics by U.S. News and World Report . NEBH has also earned The Joint Commission's Gold Seal of Approval for Advanced Certification for Total Hip and Total Knee Replacement and for Advanced Disease Specific Care for Spine Surgery. NEBH is one of only four hospitals in the nation to earn certification for Advanced Disease Specific Care for Spine Surgery. Beginning March 2019, Beth Israel Lahey Health officially embarked on a journey to transform healthcare in Massachusetts. Formed through the merger of Beth Israel Deaconess Medical Center, Lahey Health, New England Baptist Hospital, Mount Auburn Hospital, and Anna Jaques Hospital, BILH is now the second largest health system in Massachusetts with 13 hospitals. The Location: Boston is one of the most attractive locations in all of New England, with notable, professional sports teams, excellent restaurants, and an abundance of cultural attractions and sights. Its historical buildings, world-class museums, parks, and cemeteries are national landmarks, and the city boasts the birthplaces of many famous patriots, presidents, and politicians. It is the leading center of higher education in the United States. More than 200,000 students are drawn to more than two dozen universities in Boston and the surrounding communities. Please direct all inquiries, applications, and referrals to: Heather Van Hecke
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Director, Global Regulatory Affairs CMC where you accountable for the development and execution of regulatory CMC risk strategy. You will manage staff members. As part of the Global Regulatory Affairs CMC team, you will work with Regulatory, Pharmaceutical Development, and Production project teams throughout clinical development and commercial lifecycle for assigned products and staff. How you will contribute: Combines knowledge of scientific, technical, regulatory and business issues to drive and execute on global product strategy throughout development and commercial lifecycle. Demonstrate Takeda leadership behaviors. Globally influences and is considered a key opinion leader within Takeda and externally. Participate in global teams that require experienced interpretation of applicable EMA/FDA/ICH/WHO/Global regulations to ensure CMC compliance. Influences changing regulations and guidance's, interfaces with outside regulatory agencies and trade associations and acts as an advisor/liaison to senior management to plan, evaluate and recommend regulatory strategy. Ensures team effectiveness in complex matrix environment. Able to deal with issues of critical importance, provides regulatory advice and make reasoned decisions for which there may not be clear/specific regulatory guidance. Demonstrates Takeda leadership behaviors in leadership, problem-solving ability, flexibility and teamwork. Quick to adapt strategies based on regulatory and business need changes. Acts as CMC regulatory expert for developing regulatory advise on complex topics and sharing with influence to global project teams/task forces. Builds and manages relationships through active partnering with key internal and external stakeholders. Lead and contribute to department and business process improvements. Evaluate new business development opportunities or represent Global Regulatory Affairs CMC on due diligence teams. Ensure that project team colleagues, line management, and partners are informed of developments, risks and opportunities that may weigh on regulatory success. Elevate and clearly communicate actual or potential issues to stakeholders and management. Demonstrated track record for successful interactions with FDA and other global health authorities related to CMC submissions . Represent Takeda Global Regulatory Affairs CMC in Health Authority meetings and lead CMC preparation activities for meetings with Health Authorities on CMC-related matters. Significant staff management experience for staff professional development, as well as leading submission teams for marketing application, clinical trial applications, and life cycle management. What you bring to Takeda: BS/BA Degree in a Scientific Discipline, Advanced Degree preferred. 15+ years pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead, or equivalent industry experience, with international experience strongly preferred. proven experience liaising with Regulatory Agencies having served as lead in Agency Interactions and product development meetings, international experience preferred. Expert understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. Experience providing strategic regulatory guidance to drug development, registration, and post-market support teams. Provides regulatory advice and able to make/communicate difficult decisions. Demonstrated leadership, problem-solving ability, flexibility and teamwork. Excellent judgement in elevating and communicating actual or potential issues to line management. Excellent written and oral communication skills. Experience of active participation in Agency/Industry groups/forums expected. Travel Requirements: Willingness to travel to various meetings, including overnight trips. Requires approximately up to 10-30% travel. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
02/08/2023
Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Director, Global Regulatory Affairs CMC where you accountable for the development and execution of regulatory CMC risk strategy. You will manage staff members. As part of the Global Regulatory Affairs CMC team, you will work with Regulatory, Pharmaceutical Development, and Production project teams throughout clinical development and commercial lifecycle for assigned products and staff. How you will contribute: Combines knowledge of scientific, technical, regulatory and business issues to drive and execute on global product strategy throughout development and commercial lifecycle. Demonstrate Takeda leadership behaviors. Globally influences and is considered a key opinion leader within Takeda and externally. Participate in global teams that require experienced interpretation of applicable EMA/FDA/ICH/WHO/Global regulations to ensure CMC compliance. Influences changing regulations and guidance's, interfaces with outside regulatory agencies and trade associations and acts as an advisor/liaison to senior management to plan, evaluate and recommend regulatory strategy. Ensures team effectiveness in complex matrix environment. Able to deal with issues of critical importance, provides regulatory advice and make reasoned decisions for which there may not be clear/specific regulatory guidance. Demonstrates Takeda leadership behaviors in leadership, problem-solving ability, flexibility and teamwork. Quick to adapt strategies based on regulatory and business need changes. Acts as CMC regulatory expert for developing regulatory advise on complex topics and sharing with influence to global project teams/task forces. Builds and manages relationships through active partnering with key internal and external stakeholders. Lead and contribute to department and business process improvements. Evaluate new business development opportunities or represent Global Regulatory Affairs CMC on due diligence teams. Ensure that project team colleagues, line management, and partners are informed of developments, risks and opportunities that may weigh on regulatory success. Elevate and clearly communicate actual or potential issues to stakeholders and management. Demonstrated track record for successful interactions with FDA and other global health authorities related to CMC submissions . Represent Takeda Global Regulatory Affairs CMC in Health Authority meetings and lead CMC preparation activities for meetings with Health Authorities on CMC-related matters. Significant staff management experience for staff professional development, as well as leading submission teams for marketing application, clinical trial applications, and life cycle management. What you bring to Takeda: BS/BA Degree in a Scientific Discipline, Advanced Degree preferred. 15+ years pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead, or equivalent industry experience, with international experience strongly preferred. proven experience liaising with Regulatory Agencies having served as lead in Agency Interactions and product development meetings, international experience preferred. Expert understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. Experience providing strategic regulatory guidance to drug development, registration, and post-market support teams. Provides regulatory advice and able to make/communicate difficult decisions. Demonstrated leadership, problem-solving ability, flexibility and teamwork. Excellent judgement in elevating and communicating actual or potential issues to line management. Excellent written and oral communication skills. Experience of active participation in Agency/Industry groups/forums expected. Travel Requirements: Willingness to travel to various meetings, including overnight trips. Requires approximately up to 10-30% travel. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. How you will contribute: Reporting to the Director of Organizational Change Management, this position will assist in leading and coordinating change management efforts based on established OCM practices (project management, Stakeholder management, communication strategies, and implementation). They will assist and lead the planning and execution of day-to-day change management for GRA This role will assist in further developing our change management strategy to create and execute the change management plans and related deliverables throughout the program's deployment journey, from Design to Stabilize This role will partner closely with colleagues throughout the entire R&D organization starting withGlobal Regulatory Operations, under Global Regulatory Affairs. This will include (but not limited to) Regulatory Information management (RIM), Clinical Operations, PMO, Compliance, Quality, Program/Project Teams Partners with the Director and other leaders to develop the change management plan for identified projects Executes & oversees OCM plans and related deliverables to drive the required change in process and cultural behavior shifts Active participant in the Process Optimization Change Management Workstream, working as an optimization advocate Supports operational excellence & project optimization success by balancing change management activities and communication planning with appropriate communication tools Assists in the development and oversees stakeholder relationships related to optimization initiatives Fosters a sense of teamwork in all parts of the organization to actively participate in process improvement and optimization ACCOUNTABLITIES Lead and oversee Change Management Workstream activities - planning, coordination and implementation of communications and engagement projects, campaigns and programs for a wide range of internal/external audiences Assist in the definition of workstream scope and objectives with regards change and communication, involving all relevant stakeholders and ensuring relevant and timely engagement Translate business needs into operational excellence communications, creates an optimized awareness of 'this mean that' to intended audience / community Develop and oversee the creation of detailed communication plans, with appropriate metrics for monitoring effectiveness Lead and participate in curating and implementing innovative ways to communicate to stakeholders to improve visibility of team and associated initiatives Develop in collaboration with the Process Optimization Leads, compelling and meaningful Best Practice Optimization Packages to support awareness and engagement in relevant initiatives and related communities Coordinate cross-functional teams, such as GRA Training, Quality and Compliance to align on learning objectives and the execution to stakeholders Develop and maintain influencing forums, work closely to build and enhance awareness of function and initiatives and scope. CORE ELEMENTS RELATED TO THIS ROLE Explicit knowledge and experience in executing change management on a global scale, while leading global teams. DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise Demonstrate excellent planning, time management and scheduling skills for self and others contributing to the communication elements of the optimization element of that roadmap Credible engagement with cross functional stakeholders with regards the various optimization initiatives Understanding and proven experience in Learning and Development Leadership Influence others at all levels & work collaboratively across different stakeholders Strong ability to recognize and consider interdependencies of change and communications planning in a fast paced and dynamically complex business, translate to engagement solutions, communicate same at all levels Work collaboratively in a cross-functional team environment, across multiple time zones Decision-making and Autonomy Take initiative and coordinate resources to drive tasks to deadlines Demonstrate innovative solutioning skills, working with the Optimization Team/s and other identified parties, to drive proposals to anticipate and meet demand, influence decision making to feasible solutions and appropriate communications Use collaboration skills and partnerships to work within agreed Governance Model Interaction Confidently engage with external vendors and manage internal stakeholders, representing the needs of the business and those of Optimization team/s and our internal partners Express self clearly and concisely at all levels, in both verbal and written communication Demonstrate maturity of critical thinking Embrace diversity, adapt to other personalities in a respectful manner that is conducive to goal achievement Create and deliver clear and professional presentations with appropriate messaging and focused recommendations. Innovation Establish appropriate tools with which to emphasize our overall vision with the relevant stakeholders, working with Vendors and developers to ensure optimization initiatives are fully aligned to GRA transformation roadmap Identify and gain agreement for innovative analysis, reporting, and monitoring tools to assist LT/steer co's in their strive to understand hot topics within the business, providing insights from the results where appropriate. Ability to develop SharePoint sites and related tools to promote engagement with initiatives Complexity Understand the changing needs and priorities of the business, specifically in relation to GRA Understand complex issues with Transformation and to propose timely, cost-effective and achievable solutions in relation to communication and change, mindful of flexibility rather than a 'one size fits all' approach Work in a fast paced environment with demonstrated ability to delegate & juggle multiple competing tasks and demands, often with a degree of ambiguity EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: Required: Bachelor Degree or above 4+ years project experience in Healthcare/Pharmaceutical or related industry, including 3+ years client-facing and internal and/or external communication experience and 2+ years working with communication effectiveness analysis tools Working knowledge of turning business needs into 'this means that' compelling communications Excellent client-facing, internal written and verbal communication skills Solid organizational skills including attention to detail and multitasking skills Strong working knowledge of Microsoft Office including SharePoint and Teams Desired: Considerable knowledge of change management & dealing with complex and dynamic business environments, including integration projects Good working knowledge of Global Regulatory Affairs and overall R&D functions Awareness/understanding of regulatory processes, operations and standards in pharmaceutical development Excellent English verbal and written communication skills, fluency in another language beneficial Experience of working within an AGILE Framework is a plus ADDITIONAL INFORMATION International travel may be required (Up to 20%) Ability to attend offsite meetings that may involve an overnight stay This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy. In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
02/08/2023
Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. How you will contribute: Reporting to the Director of Organizational Change Management, this position will assist in leading and coordinating change management efforts based on established OCM practices (project management, Stakeholder management, communication strategies, and implementation). They will assist and lead the planning and execution of day-to-day change management for GRA This role will assist in further developing our change management strategy to create and execute the change management plans and related deliverables throughout the program's deployment journey, from Design to Stabilize This role will partner closely with colleagues throughout the entire R&D organization starting withGlobal Regulatory Operations, under Global Regulatory Affairs. This will include (but not limited to) Regulatory Information management (RIM), Clinical Operations, PMO, Compliance, Quality, Program/Project Teams Partners with the Director and other leaders to develop the change management plan for identified projects Executes & oversees OCM plans and related deliverables to drive the required change in process and cultural behavior shifts Active participant in the Process Optimization Change Management Workstream, working as an optimization advocate Supports operational excellence & project optimization success by balancing change management activities and communication planning with appropriate communication tools Assists in the development and oversees stakeholder relationships related to optimization initiatives Fosters a sense of teamwork in all parts of the organization to actively participate in process improvement and optimization ACCOUNTABLITIES Lead and oversee Change Management Workstream activities - planning, coordination and implementation of communications and engagement projects, campaigns and programs for a wide range of internal/external audiences Assist in the definition of workstream scope and objectives with regards change and communication, involving all relevant stakeholders and ensuring relevant and timely engagement Translate business needs into operational excellence communications, creates an optimized awareness of 'this mean that' to intended audience / community Develop and oversee the creation of detailed communication plans, with appropriate metrics for monitoring effectiveness Lead and participate in curating and implementing innovative ways to communicate to stakeholders to improve visibility of team and associated initiatives Develop in collaboration with the Process Optimization Leads, compelling and meaningful Best Practice Optimization Packages to support awareness and engagement in relevant initiatives and related communities Coordinate cross-functional teams, such as GRA Training, Quality and Compliance to align on learning objectives and the execution to stakeholders Develop and maintain influencing forums, work closely to build and enhance awareness of function and initiatives and scope. CORE ELEMENTS RELATED TO THIS ROLE Explicit knowledge and experience in executing change management on a global scale, while leading global teams. DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise Demonstrate excellent planning, time management and scheduling skills for self and others contributing to the communication elements of the optimization element of that roadmap Credible engagement with cross functional stakeholders with regards the various optimization initiatives Understanding and proven experience in Learning and Development Leadership Influence others at all levels & work collaboratively across different stakeholders Strong ability to recognize and consider interdependencies of change and communications planning in a fast paced and dynamically complex business, translate to engagement solutions, communicate same at all levels Work collaboratively in a cross-functional team environment, across multiple time zones Decision-making and Autonomy Take initiative and coordinate resources to drive tasks to deadlines Demonstrate innovative solutioning skills, working with the Optimization Team/s and other identified parties, to drive proposals to anticipate and meet demand, influence decision making to feasible solutions and appropriate communications Use collaboration skills and partnerships to work within agreed Governance Model Interaction Confidently engage with external vendors and manage internal stakeholders, representing the needs of the business and those of Optimization team/s and our internal partners Express self clearly and concisely at all levels, in both verbal and written communication Demonstrate maturity of critical thinking Embrace diversity, adapt to other personalities in a respectful manner that is conducive to goal achievement Create and deliver clear and professional presentations with appropriate messaging and focused recommendations. Innovation Establish appropriate tools with which to emphasize our overall vision with the relevant stakeholders, working with Vendors and developers to ensure optimization initiatives are fully aligned to GRA transformation roadmap Identify and gain agreement for innovative analysis, reporting, and monitoring tools to assist LT/steer co's in their strive to understand hot topics within the business, providing insights from the results where appropriate. Ability to develop SharePoint sites and related tools to promote engagement with initiatives Complexity Understand the changing needs and priorities of the business, specifically in relation to GRA Understand complex issues with Transformation and to propose timely, cost-effective and achievable solutions in relation to communication and change, mindful of flexibility rather than a 'one size fits all' approach Work in a fast paced environment with demonstrated ability to delegate & juggle multiple competing tasks and demands, often with a degree of ambiguity EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: Required: Bachelor Degree or above 4+ years project experience in Healthcare/Pharmaceutical or related industry, including 3+ years client-facing and internal and/or external communication experience and 2+ years working with communication effectiveness analysis tools Working knowledge of turning business needs into 'this means that' compelling communications Excellent client-facing, internal written and verbal communication skills Solid organizational skills including attention to detail and multitasking skills Strong working knowledge of Microsoft Office including SharePoint and Teams Desired: Considerable knowledge of change management & dealing with complex and dynamic business environments, including integration projects Good working knowledge of Global Regulatory Affairs and overall R&D functions Awareness/understanding of regulatory processes, operations and standards in pharmaceutical development Excellent English verbal and written communication skills, fluency in another language beneficial Experience of working within an AGILE Framework is a plus ADDITIONAL INFORMATION International travel may be required (Up to 20%) Ability to attend offsite meetings that may involve an overnight stay This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy. In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as a Scientist/ Senior Scientist where you will will accelerate drug discovery programs using binding kinetics. You will have will have strong bench scientist skills, critical thinking and analytical skills. As part of the Biologic Analytics and Automation Sciences team, you will report to the Associate Director Biologic Analytics and Automation Sciences and work with the Global Biologics team. How you will contribute: Design and execute diverse set of binding interaction studies (SPR, BLIand others) to understand antibody-antigen interactions, ligand-receptor, and enzyme-substrate binding kinetics. Develop assays for binding characterization of novel protein targets. Process and critically analyze large dataset and interpret results to drive therapeutic antibody selection. Identify and prioritize critical experiments to accelerate biologics drug discovery programs with diversifying modalities. Constantly assess and implement new technology to the existing workflow to inspire creativity. Active engagement with project team members from various cross-functional teams (Global Biologics, Drug Discovery Unit, and Pharmaceutical Sciences). Devise and implement both protein analytics and biologics discovery strategies as co-lead for discovery stage programs spanning multiple therapeutic areas including I/O-Oncology, GI/Immunology, CNS and Rare Disease. Lead developability assessment studies and coordinate Research to Development transition (R2D) of candidates. Enable intricate kinetics analysis to support MOA studies, IND filings, external assets evaluations and therapeutic candidate selection. Minimum Requirements/Qualifications: PhD degree in a scientific discipline with 8+ years experience , or MS with 12+ years experience, or BS with 14+ years experience. Minimum 5 years of industry experience in hands-on analytical characterization of biologics is required. Project and people management experience is desired. Functional area leader with strong expertise in biologics characterization including deep understanding of binding kinetics using SPR and other orthogonal methods. Effective project and resource management skills in matrix organization. Building new capabilities to broaden scope and capacity of Protein analytics workflow. Experience in presenting data and strategy to be presented across Takeda network involving multiple sites and disease areas. Experience in assay development and data analysis. Strong publication record are required. What Takeda can offer you: Comprehensive Healthcare: Medical, Dental, and Vision Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs and company match of charitable contributions Family Planning Support Flexible Work Paths Tuition reimbursement More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
02/08/2023
Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as a Scientist/ Senior Scientist where you will will accelerate drug discovery programs using binding kinetics. You will have will have strong bench scientist skills, critical thinking and analytical skills. As part of the Biologic Analytics and Automation Sciences team, you will report to the Associate Director Biologic Analytics and Automation Sciences and work with the Global Biologics team. How you will contribute: Design and execute diverse set of binding interaction studies (SPR, BLIand others) to understand antibody-antigen interactions, ligand-receptor, and enzyme-substrate binding kinetics. Develop assays for binding characterization of novel protein targets. Process and critically analyze large dataset and interpret results to drive therapeutic antibody selection. Identify and prioritize critical experiments to accelerate biologics drug discovery programs with diversifying modalities. Constantly assess and implement new technology to the existing workflow to inspire creativity. Active engagement with project team members from various cross-functional teams (Global Biologics, Drug Discovery Unit, and Pharmaceutical Sciences). Devise and implement both protein analytics and biologics discovery strategies as co-lead for discovery stage programs spanning multiple therapeutic areas including I/O-Oncology, GI/Immunology, CNS and Rare Disease. Lead developability assessment studies and coordinate Research to Development transition (R2D) of candidates. Enable intricate kinetics analysis to support MOA studies, IND filings, external assets evaluations and therapeutic candidate selection. Minimum Requirements/Qualifications: PhD degree in a scientific discipline with 8+ years experience , or MS with 12+ years experience, or BS with 14+ years experience. Minimum 5 years of industry experience in hands-on analytical characterization of biologics is required. Project and people management experience is desired. Functional area leader with strong expertise in biologics characterization including deep understanding of binding kinetics using SPR and other orthogonal methods. Effective project and resource management skills in matrix organization. Building new capabilities to broaden scope and capacity of Protein analytics workflow. Experience in presenting data and strategy to be presented across Takeda network involving multiple sites and disease areas. Experience in assay development and data analysis. Strong publication record are required. What Takeda can offer you: Comprehensive Healthcare: Medical, Dental, and Vision Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs and company match of charitable contributions Family Planning Support Flexible Work Paths Tuition reimbursement More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as Project Lead DMPK in our Cambridge, Massachusetts office. With teams based in Cambridge, MA. As a member of Global DMPK organization, you will also have cross-site interactions. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. As a Lead DMPK Project Representative for a diverse range of therapeutic modalities including: cell & gene therapies, oligonucleotides, biologics and, small molecules, you will be empowered to create and communicate a clear DMPK strategy and champion novel scientific approaches in support of Drug Discovery and Development for programs in the Takeda Portfolio. Acts as a DMPK functional leader on project teams responsible for overseeing and managing research activities within the DMPK department including assigned projects; developing and integrating the DMPK strategy to progress drug discovery programs. Ensures selection and utilization of appropriate in vitro, in vivo and/or in silico methods and models to address absorption, distribution, metabolism, excretion (ADME) and pharmacokinetic (PK)-related issues across several therapeutic areas, including: Rare Disease and Oncology and all therapeutic modalities, but most specifically related to gene therapies, oligonucleotide, biologic and cell therapies. Independently designs studies, collaborates across functions, implements extensive scientific research projects and plans within DMPK, and provides leadership to the project teams. Contributes to multiple projects, acting as senior scientific subject matter expert, and may be a project team leader and/or provide key technical knowledge to a project team. Join Takeda as a Principal Scientist, DMPK , based in Cambridge, MA. How you will contribute: ACCOUNTABILITIES Establishes project direction through integrating science, key technical knowledge, and program objectives Provides leadership to enable project teams to make informative decisions regarding selection and stage up of discovery compounds for pre-clinical development in Rare Diseases and Oncology areas Actively contributes to the evaluation of potential drug candidates for in-licensing Contributes to the preparation/editing/review of documents for regulatory submission (i.e., study reports, IB's, IND's) Independently and/or collaboratively conducts PK and PK/PD analyses during late stage lead optimization through early pre-clinical development and collaborates in PK/PD and efficacy study design to support clinical dose setting Provides strategic and hands-on leadership relating to PK and ADME issues for diverse modalities including but not limited to gene therapies, oligonucleotides, and cell therapies Develops and mentors junior DMPK team members Minimum Requirements/Qualifications: PhD degree in a scientific discipline with 6+ years experience , or MS with 10+ years experience, or BS with 12+ years experience Deep expertise in DMPK of cell & gene therapies, small molecules, oligonucleotides, or biologics, knowledge in PK/PD/E modeling and application to clinical dose setting and predicting human efficacious dose. Experience in serving on project teams in early discovery through marketing is critical. Managing the ADME and PK screening paradigm in early lead optimization, as well as early phase 1 design and human PK predictions are minimum requirements. Clear track record of accomplishments (e.g. publications, patents, presentations), including evidence of leadership in managing DMPK core activities and taking one or more internally discovered compounds into preclinical and/or clinical development. Recognized in the field of DMPK by both the pharmaceutical industry and the academic community. Excellent oral and written communication skills and an ability to interact and conduct strategic planning with colleagues in other scientific disciplines. In-depth knowledge of the overall drug discovery process and demonstrated ability to successfully direct efforts on multiple projects simultaneously. Experience in PBPK modeling is highly desired Software proficiency in Phoenix and/or Watson, GastroPlus and Simcyp is highly desired Experience in compiling and writing IND modules is desired What Takeda can offer you: Comprehensive Healthcare: Medical, Dental, and Vision Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs and company match of charitable contributions Family Planning Support Flexible Work Paths Tuition reimbursement More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
02/08/2023
Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as Project Lead DMPK in our Cambridge, Massachusetts office. With teams based in Cambridge, MA. As a member of Global DMPK organization, you will also have cross-site interactions. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. As a Lead DMPK Project Representative for a diverse range of therapeutic modalities including: cell & gene therapies, oligonucleotides, biologics and, small molecules, you will be empowered to create and communicate a clear DMPK strategy and champion novel scientific approaches in support of Drug Discovery and Development for programs in the Takeda Portfolio. Acts as a DMPK functional leader on project teams responsible for overseeing and managing research activities within the DMPK department including assigned projects; developing and integrating the DMPK strategy to progress drug discovery programs. Ensures selection and utilization of appropriate in vitro, in vivo and/or in silico methods and models to address absorption, distribution, metabolism, excretion (ADME) and pharmacokinetic (PK)-related issues across several therapeutic areas, including: Rare Disease and Oncology and all therapeutic modalities, but most specifically related to gene therapies, oligonucleotide, biologic and cell therapies. Independently designs studies, collaborates across functions, implements extensive scientific research projects and plans within DMPK, and provides leadership to the project teams. Contributes to multiple projects, acting as senior scientific subject matter expert, and may be a project team leader and/or provide key technical knowledge to a project team. Join Takeda as a Principal Scientist, DMPK , based in Cambridge, MA. How you will contribute: ACCOUNTABILITIES Establishes project direction through integrating science, key technical knowledge, and program objectives Provides leadership to enable project teams to make informative decisions regarding selection and stage up of discovery compounds for pre-clinical development in Rare Diseases and Oncology areas Actively contributes to the evaluation of potential drug candidates for in-licensing Contributes to the preparation/editing/review of documents for regulatory submission (i.e., study reports, IB's, IND's) Independently and/or collaboratively conducts PK and PK/PD analyses during late stage lead optimization through early pre-clinical development and collaborates in PK/PD and efficacy study design to support clinical dose setting Provides strategic and hands-on leadership relating to PK and ADME issues for diverse modalities including but not limited to gene therapies, oligonucleotides, and cell therapies Develops and mentors junior DMPK team members Minimum Requirements/Qualifications: PhD degree in a scientific discipline with 6+ years experience , or MS with 10+ years experience, or BS with 12+ years experience Deep expertise in DMPK of cell & gene therapies, small molecules, oligonucleotides, or biologics, knowledge in PK/PD/E modeling and application to clinical dose setting and predicting human efficacious dose. Experience in serving on project teams in early discovery through marketing is critical. Managing the ADME and PK screening paradigm in early lead optimization, as well as early phase 1 design and human PK predictions are minimum requirements. Clear track record of accomplishments (e.g. publications, patents, presentations), including evidence of leadership in managing DMPK core activities and taking one or more internally discovered compounds into preclinical and/or clinical development. Recognized in the field of DMPK by both the pharmaceutical industry and the academic community. Excellent oral and written communication skills and an ability to interact and conduct strategic planning with colleagues in other scientific disciplines. In-depth knowledge of the overall drug discovery process and demonstrated ability to successfully direct efforts on multiple projects simultaneously. Experience in PBPK modeling is highly desired Software proficiency in Phoenix and/or Watson, GastroPlus and Simcyp is highly desired Experience in compiling and writing IND modules is desired What Takeda can offer you: Comprehensive Healthcare: Medical, Dental, and Vision Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs and company match of charitable contributions Family Planning Support Flexible Work Paths Tuition reimbursement More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Manager/Manager, Global Regulatory Affairs - GI - where you will lead the global regulatory team to develop strategies to maximize regulatory success towards achievement of program objectives with supervision as appropriate. As part of the Global Regulatory Affairs team, you will report to the Director and provide regulatory strategic and tactical advice to teams with focus on non-clinical and clinical aspects of drug development to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. How you will contribute: Manage one or more projects with less complexity. May support GRL on more complex programs. May lead the Global Regulatory Team (GRT), and applicable sub-working groups and represents GRT at project team meetings. Achieve submission of INDs, CTAs, briefing packages, responses, and other submissions. Major submissions (NDA/BLA/MAA) under oversight of manager. Provide strategic and tactical guidance to teams, including regulatory review of clinical trial documents and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance. Work with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products. Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. May develop/author or assist Global Regulatory Lead with development of global regulatory strategy. Assist and attend FDA and other agency meetings. Oversee vendor responsibility for regulatory activities and submissions related to projects within scope. May participate on departmental task-forces or initiatives. What you bring to Takeda: BSc Degree preferred. BA accepted. 4 years of pharmaceutical industry experience. This is inclusive of 3 years of regulatory experience or combination of 2 years regulatory and/or related experience. Experience in reviewing, authoring, or managing components of regulatory submissions. Working knowledge of drug development process and regulatory requirements. Understand and interpret scientific data as it relates to regulatory requirements and strategy for assigned projects. Demonstrate acceptable skills in oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrate acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Must work well with others and within global teams. Able to bring working teams together for common objectives. Travel requirements: Willingness to travel to various meetings or client sites including overnight trips. Some international travel may be required. Requires approximately 10 % travel. What Takeda can offer you: Comprehensive Healthcare: Medical, Dental, and Vision Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs and company match of charitable contributions Family Planning Support Flexible Work Paths Tuition reimbursement At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
02/08/2023
Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Manager/Manager, Global Regulatory Affairs - GI - where you will lead the global regulatory team to develop strategies to maximize regulatory success towards achievement of program objectives with supervision as appropriate. As part of the Global Regulatory Affairs team, you will report to the Director and provide regulatory strategic and tactical advice to teams with focus on non-clinical and clinical aspects of drug development to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. How you will contribute: Manage one or more projects with less complexity. May support GRL on more complex programs. May lead the Global Regulatory Team (GRT), and applicable sub-working groups and represents GRT at project team meetings. Achieve submission of INDs, CTAs, briefing packages, responses, and other submissions. Major submissions (NDA/BLA/MAA) under oversight of manager. Provide strategic and tactical guidance to teams, including regulatory review of clinical trial documents and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance. Work with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products. Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. May develop/author or assist Global Regulatory Lead with development of global regulatory strategy. Assist and attend FDA and other agency meetings. Oversee vendor responsibility for regulatory activities and submissions related to projects within scope. May participate on departmental task-forces or initiatives. What you bring to Takeda: BSc Degree preferred. BA accepted. 4 years of pharmaceutical industry experience. This is inclusive of 3 years of regulatory experience or combination of 2 years regulatory and/or related experience. Experience in reviewing, authoring, or managing components of regulatory submissions. Working knowledge of drug development process and regulatory requirements. Understand and interpret scientific data as it relates to regulatory requirements and strategy for assigned projects. Demonstrate acceptable skills in oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrate acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Must work well with others and within global teams. Able to bring working teams together for common objectives. Travel requirements: Willingness to travel to various meetings or client sites including overnight trips. Some international travel may be required. Requires approximately 10 % travel. What Takeda can offer you: Comprehensive Healthcare: Medical, Dental, and Vision Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs and company match of charitable contributions Family Planning Support Flexible Work Paths Tuition reimbursement At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
Matrix Medical Network is seeking a Nurse Practitioner Family Practice for a per diem / prn job in Boston, Massachusetts. Job Description & Requirements Specialty: Family Practice Discipline: Nurse Practitioner Start Date: ASAP Duration: Ongoing Shift: flexible Employment Type: Per Diem / PRN Overview Nurse Practitioner - PRN Home Risk Assessments About Us: Matrix Medical Network offers a broad range of clinical services and proven expertise that give primary care providers and the at-risk health plan members we visit with every day the tools and knowledge to better manage their health at home. With deep roots in clinical assessment and care management services, our national network of clinicians break through traditional barriers to care by meeting those members where they are. We help older adults and other at-risk individuals enjoy a better quality of care, experience improved health outcomes, and identify chronic conditions that may otherwise go undiagnosed. Our job opportunities allow you to leverage your expertise and compassion and make a direct impact to the health and well-being of others. Join our team and be rewarded by competitive compensation while making a difference in your community! Matrix Medical Network is proud to be a Diversity, Equity, Inclusion and Accountability Employer Responsibilities About the Position: During a visit that can last up to one hour, Matrix providers review and observe a member's current health, medical history, medication adherence, social environment and other risks. This provides unmatched insight into a member's overall health and well-being that can be difficult to capture during routine office visits. The Matrix Comprehensive Health Assessment helps to improve quality of care and allows us to potentially close multiple care gaps with a single visit. Nurse Practitioner - PRN - Home Risk Assessments Type: PRN-Flexible-Nurse Practitioner Location: Home, SNF, Telehealth and other community environments in Boston, Massachusetts Hours: Days, Evening, Nights, weekend, Flexible Scheduling PAY: $105.00 per completed Assessment, 25 hours or more/month-Flexible Scheduling Mileage Reimbursement paid for all miles when 20 or more completed assessments/month, No show payment for 10 or more booked assessments/month Matrix Provider - What to Expect : Make a difference in people's lives by conducting Adult/Geriatric Assessments, medical history, diagnosis and treatment, health education, physician referrals, case management referrals, follow-up and clear documentation according to Matrix guidelines and protocols Work collaboratively with physicians, case managers, social workers, family members, key caregivers and any appropriate ancillary medical personnel as appropriate Collaborate with Primary Care Physician (PCP) on patient education, provide follow-up A nationwide network of advanced practice providers to build and maintain relationships Services may be provided in a variety of venues to include; Home Visits, Skilled Facility Visits, and Telehealth Visits THIS IS NOT A FULL TIME JOB - It is PRN/COVERAGE with no guarantee hours Qualifications Must Haves: Master's Degree required OR commensurate experience and satisfactory completion of NP licensure Current RN and NP licensure in state of practice to include prescription authority or the ability to obtain prescriptive authority Board certified by the AANP, ANCC or the AACCN in a Matrix approved specialty Have a current BLS, ACLS or CPR certification Have a Minimum of 1 year experience as a Nurse Practitioner Have strong computer skills and familiarity with Employee health/medical record software Possess excellent verbal and written communication skills with patient, clients and colleagues Be comfortable and flexible with frequent change As a clinical organization, we support vaccinations because we care about the health and safety of our colleagues and those we serve. Moreover, our clients are increasingly expecting us to be vaccinated due to the vulnerability of those we serve. As such, Matrix Medical Network requires that all team members are fully vaccinated against Influenza and COVID-19 Travel Requirements: Have the ability to travel, a valid state driver license and able to drive a car, proof of adequate automobile insurance coverage for the state of residence Travel may be required Our Culture : We have a clear vision of where we are going, and we are guided by core values that embody our organization and our culture We emphasizes innovation and growth, and you will be given the opportunities and tools to develop personally and professionally We encourage and celebrate collaboration We have a deep commitment to positively impact the communities in which we work and to make a difference in the lives of who we serve Matrix Medical Network is an Equal Employment Opportunity Employer. It is the policy of Matrix to provide equal employment opportunities without regard to race, color, religion, sex, gender identity or expression, pregnancy, age, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information or any other protected characteristic under applicable law. It is also the policy of Matrix that qualified individuals with disabilities receive equal opportunity in regard to job application procedures, hiring, and all aspects of the employment process. Matrix is committed to the full inclusion of all qualified individuals. Consistent with the Americans with Disabilities Act (ADA) and applicable state and local laws, it is the policy of Matrix to provide reasonable accommodation when requested by a qualified applicant or employee with a disability, unless such accommodation would cause an undue hardship. If reasonable accommodation is needed to participate in the job application or interview process, pre-employment testing, to otherwise participate in the selection process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact . Boston, MA 02119 Primary Location: Boston, MA 02119 Job: Clinical-Nurse Practitioner or NP. Regular Shift. Full or Part Time Job Level: Day Job, 8am, 5pm, Travel, Monday, Friday. No on-call, no evening, no weekend hours unless desired. Job, Clinical, Nursing, Work from Home Opportunity, Regular, Job Type, Standard, Travel, Flexible, Pay, No Call, Hours. Matrix Medical Network Job ID . Posted job title: Nurse Practitioner- PRN About Matrix Medical Network Matrix Clinical Care offers a broad range of clinical services and proven expertise that gives health plans, primary care providers, and employers the tools and knowledge they need to better manage the health of at-risk populations at home. With its deep roots in clinical assessment and care management services, Matrix's network of clinicians break through traditional barriers to care access by meeting members where they are. Matrix, in partnership with its expert clinical advisory panel, offers customizable solutions across four distinct lines of business via in-home visits, telehealth, on-site support at medical facilities and businesses, and Mobile Health Clinics: Matrix Clinical Care helps seniors and other at-risk individuals enjoy a better quality of care, experience better health outcomes, and identify chronic conditions that may otherwise go undiagnosed. Matrix Clinical Solutions helps keep workers healthy and businesses run productively by designing custom workplace health solutions and providing testing, tracing, and clinical care solutions. Matrix also offers a safety verified certification program developed in collaboration with the Cleveland Clinic. Matrix Clinical Labs is a CLIA-certified and CAP-accredited laboratory that provides state-of-the-art diagnostic services and clinical testing support. Benefits Medical benefits Vision benefits 401k retirement plan Continuing Education Holiday Pay Dental benefits
02/08/2023
Full time
Matrix Medical Network is seeking a Nurse Practitioner Family Practice for a per diem / prn job in Boston, Massachusetts. Job Description & Requirements Specialty: Family Practice Discipline: Nurse Practitioner Start Date: ASAP Duration: Ongoing Shift: flexible Employment Type: Per Diem / PRN Overview Nurse Practitioner - PRN Home Risk Assessments About Us: Matrix Medical Network offers a broad range of clinical services and proven expertise that give primary care providers and the at-risk health plan members we visit with every day the tools and knowledge to better manage their health at home. With deep roots in clinical assessment and care management services, our national network of clinicians break through traditional barriers to care by meeting those members where they are. We help older adults and other at-risk individuals enjoy a better quality of care, experience improved health outcomes, and identify chronic conditions that may otherwise go undiagnosed. Our job opportunities allow you to leverage your expertise and compassion and make a direct impact to the health and well-being of others. Join our team and be rewarded by competitive compensation while making a difference in your community! Matrix Medical Network is proud to be a Diversity, Equity, Inclusion and Accountability Employer Responsibilities About the Position: During a visit that can last up to one hour, Matrix providers review and observe a member's current health, medical history, medication adherence, social environment and other risks. This provides unmatched insight into a member's overall health and well-being that can be difficult to capture during routine office visits. The Matrix Comprehensive Health Assessment helps to improve quality of care and allows us to potentially close multiple care gaps with a single visit. Nurse Practitioner - PRN - Home Risk Assessments Type: PRN-Flexible-Nurse Practitioner Location: Home, SNF, Telehealth and other community environments in Boston, Massachusetts Hours: Days, Evening, Nights, weekend, Flexible Scheduling PAY: $105.00 per completed Assessment, 25 hours or more/month-Flexible Scheduling Mileage Reimbursement paid for all miles when 20 or more completed assessments/month, No show payment for 10 or more booked assessments/month Matrix Provider - What to Expect : Make a difference in people's lives by conducting Adult/Geriatric Assessments, medical history, diagnosis and treatment, health education, physician referrals, case management referrals, follow-up and clear documentation according to Matrix guidelines and protocols Work collaboratively with physicians, case managers, social workers, family members, key caregivers and any appropriate ancillary medical personnel as appropriate Collaborate with Primary Care Physician (PCP) on patient education, provide follow-up A nationwide network of advanced practice providers to build and maintain relationships Services may be provided in a variety of venues to include; Home Visits, Skilled Facility Visits, and Telehealth Visits THIS IS NOT A FULL TIME JOB - It is PRN/COVERAGE with no guarantee hours Qualifications Must Haves: Master's Degree required OR commensurate experience and satisfactory completion of NP licensure Current RN and NP licensure in state of practice to include prescription authority or the ability to obtain prescriptive authority Board certified by the AANP, ANCC or the AACCN in a Matrix approved specialty Have a current BLS, ACLS or CPR certification Have a Minimum of 1 year experience as a Nurse Practitioner Have strong computer skills and familiarity with Employee health/medical record software Possess excellent verbal and written communication skills with patient, clients and colleagues Be comfortable and flexible with frequent change As a clinical organization, we support vaccinations because we care about the health and safety of our colleagues and those we serve. Moreover, our clients are increasingly expecting us to be vaccinated due to the vulnerability of those we serve. As such, Matrix Medical Network requires that all team members are fully vaccinated against Influenza and COVID-19 Travel Requirements: Have the ability to travel, a valid state driver license and able to drive a car, proof of adequate automobile insurance coverage for the state of residence Travel may be required Our Culture : We have a clear vision of where we are going, and we are guided by core values that embody our organization and our culture We emphasizes innovation and growth, and you will be given the opportunities and tools to develop personally and professionally We encourage and celebrate collaboration We have a deep commitment to positively impact the communities in which we work and to make a difference in the lives of who we serve Matrix Medical Network is an Equal Employment Opportunity Employer. It is the policy of Matrix to provide equal employment opportunities without regard to race, color, religion, sex, gender identity or expression, pregnancy, age, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information or any other protected characteristic under applicable law. It is also the policy of Matrix that qualified individuals with disabilities receive equal opportunity in regard to job application procedures, hiring, and all aspects of the employment process. Matrix is committed to the full inclusion of all qualified individuals. Consistent with the Americans with Disabilities Act (ADA) and applicable state and local laws, it is the policy of Matrix to provide reasonable accommodation when requested by a qualified applicant or employee with a disability, unless such accommodation would cause an undue hardship. If reasonable accommodation is needed to participate in the job application or interview process, pre-employment testing, to otherwise participate in the selection process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact . Boston, MA 02119 Primary Location: Boston, MA 02119 Job: Clinical-Nurse Practitioner or NP. Regular Shift. Full or Part Time Job Level: Day Job, 8am, 5pm, Travel, Monday, Friday. No on-call, no evening, no weekend hours unless desired. Job, Clinical, Nursing, Work from Home Opportunity, Regular, Job Type, Standard, Travel, Flexible, Pay, No Call, Hours. Matrix Medical Network Job ID . Posted job title: Nurse Practitioner- PRN About Matrix Medical Network Matrix Clinical Care offers a broad range of clinical services and proven expertise that gives health plans, primary care providers, and employers the tools and knowledge they need to better manage the health of at-risk populations at home. With its deep roots in clinical assessment and care management services, Matrix's network of clinicians break through traditional barriers to care access by meeting members where they are. Matrix, in partnership with its expert clinical advisory panel, offers customizable solutions across four distinct lines of business via in-home visits, telehealth, on-site support at medical facilities and businesses, and Mobile Health Clinics: Matrix Clinical Care helps seniors and other at-risk individuals enjoy a better quality of care, experience better health outcomes, and identify chronic conditions that may otherwise go undiagnosed. Matrix Clinical Solutions helps keep workers healthy and businesses run productively by designing custom workplace health solutions and providing testing, tracing, and clinical care solutions. Matrix also offers a safety verified certification program developed in collaboration with the Cleveland Clinic. Matrix Clinical Labs is a CLIA-certified and CAP-accredited laboratory that provides state-of-the-art diagnostic services and clinical testing support. Benefits Medical benefits Vision benefits 401k retirement plan Continuing Education Holiday Pay Dental benefits
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Manager/Senior Manager, Global Regulatory Affairs - Oncology in our Cambridge, MA office. OBJECTIVES: Oversees as well as executes all regulatory activities of multiple projects including one highly complex project in development and/or supports regulatory activities for assigned marketed product(s) of responsibility. Provides a regulatory strategic focus on non-clinical and clinical aspects of drug development and associated regulations. May serve as global regulatory lead (GRL) on the global project team (GPT) for individual project(s) of responsibility Collaborates with all Takeda regions to ensure a global regulatory strategy is created and executed upon for all projects within area of responsibility. May be primary FDA contact for projects of responsibility. ACCOUNTABILITIES: Responsible for achieving submission of INDs, CTAs, briefing packages, responses, and other submissions. Major submissions (NDA/BLA/MAA) under oversight of manager. Accountable for ensuring all other regulatory submissions within the non-US "Americas" territories are submitted on schedule by local Takeda affiliates or development partners (eg, PRA or co-development partners) within project(s) of responsibility by ensuring the regulatory deliverables are provided as outlined in the global regulatory strategy. May develop/author or assist Global Regulatory Lead with development of global regulatory strategy. For the project(s) of responsibility, collaborates with EU and/or other regional counterparts in the authoring of global regulatory strategies and ensures critical deliverables to territories outside the US to ensure regional execution of the strategy as agreed within the global regulatory strategy Executes day-to-day activities for projects or delegates to staff with oversight. Identifies regulatory requirements and provides regulatory guidance, and expertise to global development team on the assigned project(s) of responsibility. Assists and attends FDA and other agency meetings. Identifies and notifies management of any resource gaps for project responsibility. Provides oversight to ensure regulatory compliance of marketed products. Present to senior management as requested. EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: BSc Degree preferred. BA accepted. A minimum of 4 years of pharmaceutical industry experience. This is inclusive of 3 years of regulatory experience or combination of 4 years regulatory and/or related experience. Preferred experience in reviewing, authoring, or managing components of regulatory submissions. Working knowledge of drug development process and regulatory requirements. Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects. Demonstrates acceptable skills in oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Must work well with others and within global teams. Able to bring working teams together for common objectives. TRAVEL REQUIREMENTS: Willingness to travel to various meetings or client sites including overnight trips. Some international travel may be required. Requires approximately 10 % travel. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
02/08/2023
Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Manager/Senior Manager, Global Regulatory Affairs - Oncology in our Cambridge, MA office. OBJECTIVES: Oversees as well as executes all regulatory activities of multiple projects including one highly complex project in development and/or supports regulatory activities for assigned marketed product(s) of responsibility. Provides a regulatory strategic focus on non-clinical and clinical aspects of drug development and associated regulations. May serve as global regulatory lead (GRL) on the global project team (GPT) for individual project(s) of responsibility Collaborates with all Takeda regions to ensure a global regulatory strategy is created and executed upon for all projects within area of responsibility. May be primary FDA contact for projects of responsibility. ACCOUNTABILITIES: Responsible for achieving submission of INDs, CTAs, briefing packages, responses, and other submissions. Major submissions (NDA/BLA/MAA) under oversight of manager. Accountable for ensuring all other regulatory submissions within the non-US "Americas" territories are submitted on schedule by local Takeda affiliates or development partners (eg, PRA or co-development partners) within project(s) of responsibility by ensuring the regulatory deliverables are provided as outlined in the global regulatory strategy. May develop/author or assist Global Regulatory Lead with development of global regulatory strategy. For the project(s) of responsibility, collaborates with EU and/or other regional counterparts in the authoring of global regulatory strategies and ensures critical deliverables to territories outside the US to ensure regional execution of the strategy as agreed within the global regulatory strategy Executes day-to-day activities for projects or delegates to staff with oversight. Identifies regulatory requirements and provides regulatory guidance, and expertise to global development team on the assigned project(s) of responsibility. Assists and attends FDA and other agency meetings. Identifies and notifies management of any resource gaps for project responsibility. Provides oversight to ensure regulatory compliance of marketed products. Present to senior management as requested. EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: BSc Degree preferred. BA accepted. A minimum of 4 years of pharmaceutical industry experience. This is inclusive of 3 years of regulatory experience or combination of 4 years regulatory and/or related experience. Preferred experience in reviewing, authoring, or managing components of regulatory submissions. Working knowledge of drug development process and regulatory requirements. Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects. Demonstrates acceptable skills in oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Must work well with others and within global teams. Able to bring working teams together for common objectives. TRAVEL REQUIREMENTS: Willingness to travel to various meetings or client sites including overnight trips. Some international travel may be required. Requires approximately 10 % travel. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
Perks & Benefits of Senior Accountant Include: Competitive Compensation Hybrid Position in Greater Boston: Challenging, exciting consulting work without the overnight or long-distance travel Health, Dental, Life, Short Term, and Long Term Disability insurance Generous paid time off (Unlimited after two years of service) Company Holidays Tuition Reimbursement 401K with company matching About Insource: Insource provides expertise to our clients in the areas of HR, Finance, and IT. Our clients include a diverse mix of businesses ranging from small venture-backed startups to well-established nonprofit organizations. We work closely with our client's staff, providing them access to the specialized knowledge they need to successfully operate and grow their businesses. We love solving problems and identifying opportunities for efficiency improvements for our clients. In fact, everything we do at Insource is focused on helping our clients achieve their mission and business goals. We invest in our client relationships and passionately care about the service we deliver. Everything we do is centered on our core beliefs and we believe: Understanding our client's culture and vision make us a better partner Our cross-content perspective adds unique value to our clients HR, Finance and IT start with people There is always more than one way to solve a problem In doing the right things for the right reason Being easy to work with is core to who we are Communication needs to be direct and candid Happy staff leads to happy clients What You'll Do as a Senior Accountant: Working as part of a service delivery team, you will provide routine accounting services to our clients. Responsibilities include processing accounts payable, accounts receivable, cash disbursements, and cash receipts using QuickBooks or other accounting software packages, processing and reviewing payroll, maintaining GL, processing journal entries, reconciling and maintaining balance sheet, and accepting additional leadership responsibilities as needed to support Accounting and Bookkeeping Manager On a monthly basis you will maintain chart of accounts, jobs, and classes under the direction of the manager and/or client consultant, update schedules of temporarily restricted revenue and net assets for nonprofit clients; post relevant updates to the general ledger and run reports used for financial analysis to support of management decision-making On an annual basis, you will play a key role in the closing process at month-end and year-end, updating relevant schedules and posting in the GL, document standard operating procedures for clients, prepare 1099s and other tax filings, assist with year-end tasks, including gathering data for budget processes, audit preparation, and client-specific regulatory filings On an ongoing basis, you will take ownership of some tasks related to audit cycle, including project management of PBC listings and preparation of schedules, prepare & analyze management reports for client team review, actively participate in staff meetings on processes or items of interest in our work and set up and maintain electronic and paper files. You will also train staff accountants as needed and oversee the work of other accountants Travel to client sites for meetings and onsite processing as needed/requested What We're Looking For in a Senior Accountant: Proven accounting experience, with at least 3 years of experience in a small to mid-sized company or nonprofit Experience organizing, preparing, and analyzing financial data working individually or as part of a team Participation during audit preparation and playing a role in an audit from planning to closing Ability to adhere to time allocations for client work and/or work proactively with supervisor on efficiencies or modifications in order to do so Demonstrated understanding of P&L and balance sheet, ability to consistently and accurately reconcile balance sheet accounts, knowledge of the accounting cycle for client organizations, efficient and accurate entry of accounting transactions into the general ledger Ability to proficiently work within Excel, interpret complex worksheets and charts, and utilize formulas and pivot tables Proactive support of the Accounting and Bookkeeping Manager and serving as a mentor to staff accountants Standard Company Competencies: Adherence to the professional and ethical standards set forth by Insource Services while understanding and projecting Insource's ethos Initiative to self-educate on client business, products, and/or services Commitment to Insource's sustainable business practices and initiatives Functional Competencies: Work may be subject to frequent interruptions Exposure to computer screens, extensive use of computer and keyboard Find Us On: Facebook: Linkedin: Twitter: We provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, veteran status, or any other characteristic protected by federal, state or local law. In addition, Insource Services will provide reasonable accommodations for qualified individuals with disabilities Job Type: Full-time Benefits: 401(k) 401(k) matching Dental insurance Disability insurance Employee assistance program Flexible spending account Health insurance Life insurance Paid time off Tuition reimbursement Vision insurance Schedule: 8 hour shift Monday to Friday Ability to commute/relocate: Boston, MA 02108: Reliably commute or planning to relocate before starting work (Preferred) Application Question(s): Please indicate your target salary range. Experience: Accounting: 3 years (Preferred) NetSuite: 2 years (Preferred) Work Location: Hybrid remote in Boston, MA 02108
02/08/2023
Full time
Perks & Benefits of Senior Accountant Include: Competitive Compensation Hybrid Position in Greater Boston: Challenging, exciting consulting work without the overnight or long-distance travel Health, Dental, Life, Short Term, and Long Term Disability insurance Generous paid time off (Unlimited after two years of service) Company Holidays Tuition Reimbursement 401K with company matching About Insource: Insource provides expertise to our clients in the areas of HR, Finance, and IT. Our clients include a diverse mix of businesses ranging from small venture-backed startups to well-established nonprofit organizations. We work closely with our client's staff, providing them access to the specialized knowledge they need to successfully operate and grow their businesses. We love solving problems and identifying opportunities for efficiency improvements for our clients. In fact, everything we do at Insource is focused on helping our clients achieve their mission and business goals. We invest in our client relationships and passionately care about the service we deliver. Everything we do is centered on our core beliefs and we believe: Understanding our client's culture and vision make us a better partner Our cross-content perspective adds unique value to our clients HR, Finance and IT start with people There is always more than one way to solve a problem In doing the right things for the right reason Being easy to work with is core to who we are Communication needs to be direct and candid Happy staff leads to happy clients What You'll Do as a Senior Accountant: Working as part of a service delivery team, you will provide routine accounting services to our clients. Responsibilities include processing accounts payable, accounts receivable, cash disbursements, and cash receipts using QuickBooks or other accounting software packages, processing and reviewing payroll, maintaining GL, processing journal entries, reconciling and maintaining balance sheet, and accepting additional leadership responsibilities as needed to support Accounting and Bookkeeping Manager On a monthly basis you will maintain chart of accounts, jobs, and classes under the direction of the manager and/or client consultant, update schedules of temporarily restricted revenue and net assets for nonprofit clients; post relevant updates to the general ledger and run reports used for financial analysis to support of management decision-making On an annual basis, you will play a key role in the closing process at month-end and year-end, updating relevant schedules and posting in the GL, document standard operating procedures for clients, prepare 1099s and other tax filings, assist with year-end tasks, including gathering data for budget processes, audit preparation, and client-specific regulatory filings On an ongoing basis, you will take ownership of some tasks related to audit cycle, including project management of PBC listings and preparation of schedules, prepare & analyze management reports for client team review, actively participate in staff meetings on processes or items of interest in our work and set up and maintain electronic and paper files. You will also train staff accountants as needed and oversee the work of other accountants Travel to client sites for meetings and onsite processing as needed/requested What We're Looking For in a Senior Accountant: Proven accounting experience, with at least 3 years of experience in a small to mid-sized company or nonprofit Experience organizing, preparing, and analyzing financial data working individually or as part of a team Participation during audit preparation and playing a role in an audit from planning to closing Ability to adhere to time allocations for client work and/or work proactively with supervisor on efficiencies or modifications in order to do so Demonstrated understanding of P&L and balance sheet, ability to consistently and accurately reconcile balance sheet accounts, knowledge of the accounting cycle for client organizations, efficient and accurate entry of accounting transactions into the general ledger Ability to proficiently work within Excel, interpret complex worksheets and charts, and utilize formulas and pivot tables Proactive support of the Accounting and Bookkeeping Manager and serving as a mentor to staff accountants Standard Company Competencies: Adherence to the professional and ethical standards set forth by Insource Services while understanding and projecting Insource's ethos Initiative to self-educate on client business, products, and/or services Commitment to Insource's sustainable business practices and initiatives Functional Competencies: Work may be subject to frequent interruptions Exposure to computer screens, extensive use of computer and keyboard Find Us On: Facebook: Linkedin: Twitter: We provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, veteran status, or any other characteristic protected by federal, state or local law. In addition, Insource Services will provide reasonable accommodations for qualified individuals with disabilities Job Type: Full-time Benefits: 401(k) 401(k) matching Dental insurance Disability insurance Employee assistance program Flexible spending account Health insurance Life insurance Paid time off Tuition reimbursement Vision insurance Schedule: 8 hour shift Monday to Friday Ability to commute/relocate: Boston, MA 02108: Reliably commute or planning to relocate before starting work (Preferred) Application Question(s): Please indicate your target salary range. Experience: Accounting: 3 years (Preferred) NetSuite: 2 years (Preferred) Work Location: Hybrid remote in Boston, MA 02108
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as an Associate Director (AD)/Director, Global Regulatory Affairs-Oncology in our Cambridge office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an AD/Director, Global Regulatory Affairs-Oncology working on the Global Regulatory Affairs team, you will be responsible for complex or highly complex or multiple projects and lead the Global Regulatory Teams (GRTs), and a typical day will include: Objectives: Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. Is a leader both in the department and within R&D, contributing to cross-functional initiatives and influencing the field as applicable. Provides leadership and development for direct reports if applicable, including those that serve as global regulatory leads responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts. Accountabilities: The AD/Director will be responsible for complex or highly complex or multiple projects. Leads the Global Regulatory Teams (GRTs) and applicable sub-working groups, such as the Label Working Group, and represents GRTs at project team meetings. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible. Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Proactively anticipates risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions. Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports responsible. The AD/Director will lead all submission types. Direct point of contact with health authorities, leads and manages FDA meetings. Manages direct reports or junior staff as needed. Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products. Oversee vendor responsibility for regulatory activities and submissions related to projects within scope. Participates with influence in or leads departmental and cross-functional task-forces and initiatives. Lead regulatory reviewer in due diligence for licensing opportunities. Partner with global market access colleagues to Lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable. Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner. Responsible for demonstrating Takeda leadership behaviors Requirements: BSc/BA Degree, scientific discipline strongly preferred. Advanced degree in a scientific discipline (PharmD/PhD/MD) strongly preferred 8+ years of relevant scientific/pharmaceutical industry experience. Preferred experience in reviewing, authoring, or managing components of regulatory submissions. Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus. Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy. Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy. Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Must work well with others and within global teams. Able to bring working teams together for common objectives. Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Location and Salary Information: This job posting excludes CO applicants. WHAT TAKEDA CAN OFFER YOU: 401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
02/08/2023
Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as an Associate Director (AD)/Director, Global Regulatory Affairs-Oncology in our Cambridge office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an AD/Director, Global Regulatory Affairs-Oncology working on the Global Regulatory Affairs team, you will be responsible for complex or highly complex or multiple projects and lead the Global Regulatory Teams (GRTs), and a typical day will include: Objectives: Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. Is a leader both in the department and within R&D, contributing to cross-functional initiatives and influencing the field as applicable. Provides leadership and development for direct reports if applicable, including those that serve as global regulatory leads responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts. Accountabilities: The AD/Director will be responsible for complex or highly complex or multiple projects. Leads the Global Regulatory Teams (GRTs) and applicable sub-working groups, such as the Label Working Group, and represents GRTs at project team meetings. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible. Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Proactively anticipates risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions. Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports responsible. The AD/Director will lead all submission types. Direct point of contact with health authorities, leads and manages FDA meetings. Manages direct reports or junior staff as needed. Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products. Oversee vendor responsibility for regulatory activities and submissions related to projects within scope. Participates with influence in or leads departmental and cross-functional task-forces and initiatives. Lead regulatory reviewer in due diligence for licensing opportunities. Partner with global market access colleagues to Lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable. Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner. Responsible for demonstrating Takeda leadership behaviors Requirements: BSc/BA Degree, scientific discipline strongly preferred. Advanced degree in a scientific discipline (PharmD/PhD/MD) strongly preferred 8+ years of relevant scientific/pharmaceutical industry experience. Preferred experience in reviewing, authoring, or managing components of regulatory submissions. Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus. Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy. Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy. Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Must work well with others and within global teams. Able to bring working teams together for common objectives. Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Location and Salary Information: This job posting excludes CO applicants. WHAT TAKEDA CAN OFFER YOU: 401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Manager, Programming where you will be team-oriented and collaborative, with a strong understanding of the statistical programming function. Takeda is a global, values-based, R&D-driven, top 10 biopharmaceutical leader committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. As part of the Statistical Programming team, you will report to the Executive Director, Programming and work with the Statistical Quantitative Sciences (SQS) organization. How you will contribute: Lead study level programming and oversight activities ensuring quality and timeliness Manage assigned tasks, identify the need for and seek input from others Engage cross functionally to progress tasks with influencing skills Contribute to process improvement initiatives Establish internal and external presence on topics of interest Apply strong general knowledge of technical and programming methods with applied experience Drive programming activities within study team to ensure quality and timeliness Have a strong knowledge of CDISC standards, medical terminology, clinical trial methodologies, and FDA/ICH regulations Participate in initiatives that seek diverse input from multiple members and stakeholders to drive innovative solutions Implement R&D's partnership strategy as it applies to statistical programming Collaborate with other interfacing Takeda functions, including statistics, data management, clinical operations Recommend technical solutions using a wide variety of software (e.g. SAS, R, Python) Communicate ideas around possible innovative solutions, and ways to accelerate existing milestones Have awareness of best practices with data sharing and programming input and standardization for novel data such as real world data, digital data, wearable device data Minimum Requirements/Qualifications: MS with 4+ years of industry related experience BS with 6+ years of industry related experience Experience contributing to business process transformation and organizational culture change and providing programming expertise on programs with complex business deliverables Operational experience in pharmaceutical drug development with direct exposure to clinical development Health care business acumen with a comprehensive understanding of the pharmaceutical industry What Takeda can offer you: Comprehensive Healthcare: Medical, Dental, and Vision Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs and company match of charitable contributions Family Planning Support Flexible Work Paths Tuition reimbursement More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy. Base Salary Range: $102,200.00 to $146,000.00 based on candidate professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off. The final salary offered for this position may take into account a number of factors including , but not limited to, location, skills, education, and experience. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Massachusetts - Virtual Worker Type Employee Worker Sub-Type Regular Time Type Full time
02/08/2023
Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Manager, Programming where you will be team-oriented and collaborative, with a strong understanding of the statistical programming function. Takeda is a global, values-based, R&D-driven, top 10 biopharmaceutical leader committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. As part of the Statistical Programming team, you will report to the Executive Director, Programming and work with the Statistical Quantitative Sciences (SQS) organization. How you will contribute: Lead study level programming and oversight activities ensuring quality and timeliness Manage assigned tasks, identify the need for and seek input from others Engage cross functionally to progress tasks with influencing skills Contribute to process improvement initiatives Establish internal and external presence on topics of interest Apply strong general knowledge of technical and programming methods with applied experience Drive programming activities within study team to ensure quality and timeliness Have a strong knowledge of CDISC standards, medical terminology, clinical trial methodologies, and FDA/ICH regulations Participate in initiatives that seek diverse input from multiple members and stakeholders to drive innovative solutions Implement R&D's partnership strategy as it applies to statistical programming Collaborate with other interfacing Takeda functions, including statistics, data management, clinical operations Recommend technical solutions using a wide variety of software (e.g. SAS, R, Python) Communicate ideas around possible innovative solutions, and ways to accelerate existing milestones Have awareness of best practices with data sharing and programming input and standardization for novel data such as real world data, digital data, wearable device data Minimum Requirements/Qualifications: MS with 4+ years of industry related experience BS with 6+ years of industry related experience Experience contributing to business process transformation and organizational culture change and providing programming expertise on programs with complex business deliverables Operational experience in pharmaceutical drug development with direct exposure to clinical development Health care business acumen with a comprehensive understanding of the pharmaceutical industry What Takeda can offer you: Comprehensive Healthcare: Medical, Dental, and Vision Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs and company match of charitable contributions Family Planning Support Flexible Work Paths Tuition reimbursement More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy. Base Salary Range: $102,200.00 to $146,000.00 based on candidate professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off. The final salary offered for this position may take into account a number of factors including , but not limited to, location, skills, education, and experience. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Massachusetts - Virtual Worker Type Employee Worker Sub-Type Regular Time Type Full time
Our client, a nonprofit located in Boston, is seeking a temporary Events Assistant to join their team through August 2023. This fulltime contract position (April 1 - August, 2023) will execute events strategy and lead special initiatives to support the mission, build awareness and interest in the organization's events, engage volunteers, donors and other stakeholders and meet annual fundraising goals. Interested candidates are encouraged to apply today for immediate consideration! hours: 9 to 5, hybrid Boston pay 22-23/hr Various Event Responsibilities: Assist in managing the planning committee, including staff, board members and volunteers (as needed) Solicit auction donations from new and existing donors to reach goals and oversee collection of item forms/information Assist in creating online auction catalog Train, supervise, and support event vendors, volunteers and staff Serve as point person for event, moving event logistics tasks forward as necessary Develop fundraising toolkit; and train and support riders in their own fundraising Work with the Marketing & Communications Manager to craft engaging emails and social media posts to support recruitment, engagement, and fundraising Serve as primary point person for event coordination for other smaller events throughout the year Experience: Experience in events planning, fundraising, or other relevant experience Ability to engage and excite volunteers Proficiency with DonorPerfect / Ready Set Auction or similar donor management and event / auction software, and Google Suite Flexible, ability to prioritize, adapt to change and shifting priorities and to work simultaneously on a variety of complex projects Strong analytical and critical thinking skills Must be able to work independently and collaboratively Experience handling confidential materials and information with discretion Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply. If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser: Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records. Company Profile: Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement. Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs. Learn more about Beacon Hill Staffing Group and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Life Sciences and Beacon Hill Technologies by visiting . We look forward to working with you. Beacon Hill. Employing the Future (TM)
02/08/2023
Full time
Our client, a nonprofit located in Boston, is seeking a temporary Events Assistant to join their team through August 2023. This fulltime contract position (April 1 - August, 2023) will execute events strategy and lead special initiatives to support the mission, build awareness and interest in the organization's events, engage volunteers, donors and other stakeholders and meet annual fundraising goals. Interested candidates are encouraged to apply today for immediate consideration! hours: 9 to 5, hybrid Boston pay 22-23/hr Various Event Responsibilities: Assist in managing the planning committee, including staff, board members and volunteers (as needed) Solicit auction donations from new and existing donors to reach goals and oversee collection of item forms/information Assist in creating online auction catalog Train, supervise, and support event vendors, volunteers and staff Serve as point person for event, moving event logistics tasks forward as necessary Develop fundraising toolkit; and train and support riders in their own fundraising Work with the Marketing & Communications Manager to craft engaging emails and social media posts to support recruitment, engagement, and fundraising Serve as primary point person for event coordination for other smaller events throughout the year Experience: Experience in events planning, fundraising, or other relevant experience Ability to engage and excite volunteers Proficiency with DonorPerfect / Ready Set Auction or similar donor management and event / auction software, and Google Suite Flexible, ability to prioritize, adapt to change and shifting priorities and to work simultaneously on a variety of complex projects Strong analytical and critical thinking skills Must be able to work independently and collaboratively Experience handling confidential materials and information with discretion Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply. If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser: Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records. Company Profile: Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement. Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs. Learn more about Beacon Hill Staffing Group and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Life Sciences and Beacon Hill Technologies by visiting . We look forward to working with you. Beacon Hill. Employing the Future (TM)
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. OBJECTIVE: The Lead International Advertising and Promotion (A&P) serves as an internal expert on International, EFPIA, and regulations, guidance governing the promotion of prescription drug and biologic products and disease awareness activities. The Lead International Advertising and Promotion (A&P) serves as the reviewer for pipeline compounds and as such must have an understanding of the EphMRA Code governing market research activities. Capable of providing regulatory strategic oversight for at least one (1) complex product or therapeutic area/multiple products to help ensure regulatory compliance of promotional and non-promotional materials generated for assigned products and/or compounds. Assists in the development, integration, and implementation of internal policies, work instructions, guidances and regional and LOC specific requirements, in collaboration with the A&P Group Lead. The role serves as the process expert and is the lead for applicable A&P projects to ensure collaboration with key stakeholders and completion as planned. Works collaboratively with colleagues in Regulatory Affairs, Medical, Legal, Commercial and Ethics & Compliance organizations and applies expertise to ensure that the development of promotional and disease state materials is accomplished through compliance with internal processes and standards. Responsible for selected LOC's in a designated region to support the strategy and integration and implementation of the Local review process variations, working instructions and assist in local complaint management in order to ensure consistency with the International processes. Supports the development, integration and implementation of directed and agreed future development and improvement of the global review process, standards . ACCOUNTABILITIES: Evaluates materials to ensure compliance with International regulations, guidance, corporate standards and policies and business objectives. In collaboration with Commercial, Medical and Legal colleagues, conducts a detailed review and evaluation of the adequacy of clinical evidence provided to support proposed claims that are consistent with product labeling. Provides consistent, well-supported, and clear guidance to key stakeholders. Serves as the chair of CMLR review meetings and assists Commercial with the planning and prioritization of proposed promotional and disease state materials. Provides expert guidance related to Regulatory strategy to commerical and key stakeholders during early development of projects to ensure promotional goals can be achieved (e.g., target product profile; clinical trial recruitment materials). Participates in CMLR meetings to resolve potential issues and participates in escalation meetings, as needed. Supports metrics to measure and track effectiveness and efficiency of the CMLR review process; provides recommendations for process improvements to address issues, gains agreement of process improvements from key stakeholders, and helps implement agreed-upon process improvements. Understands broad concepts within regulatory affairs and potential implications across organization. Proactively identifies regulatory issues. Offers creative solutions and strategies, including risk mitigation strategies. Leads internal A&P project workstreams (e.g., guidance documents) and active participant at team staff meetings Being the contact point and expert matter for the promotional review process and International review standards for selected LOC's within the designated region Supports the development, integration and update of the LOC processes and standards for promotional & non-promotional review and ensure full training implementation for selected LOC's within the designated region. Address unmet LOC needs for selected LOC's within the designated region through LOC discussions and the development of online collaboration tools. Being key contact person for selected LOC's within the designated region for complaints regarding promotional or disease awareness materials/activities in the designated region to drive centralisation and global coordination and identify potential competitor trends or risks that require further legal action. Collaborates with the US CMLR review teams for materials that are intended for global audiences (e.g., global press releases, new global campaigns). EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: Required: Bachelor's Degree in a science-related field Ability to understand EFPIA and International (ex-US) regulations basics on advertising and promotion for prescription products Ability to understand the basics in pharmaceutical promotion development and reviewprocess Strong interpersonal skills with ability to demonstrate strategic and analytic thinking Demonstrated ability to clearly and concisely communicate. Effective written and verbal communication skills in order to manage, motivate and drive decisions within teams. Proven skills in negotiation, influencing without authority and working diplomatically through conflict. Ability to work independently, take initiative and complete tasks to deadlines Previous experience in advertising and promotion; experience in managing regulatory filing(s) or competitor complaints or medical communication/information. Desired: Minimum of 2 year experience in International review and approval process of pharmaceutical/biologics promotion Skills: Leadership Skills - ability to effectively manage and bring working teams together for common objectives Strategic Approach - u nderstands the phases, processes and techniques used within a clinical development environment, can contribute to clinical study design discussions as needed. Analytical and Problem-Solving Skills - ability to understand complex issues and propose achievable solutions. Communication Skills - ability to express one's self clearly and concisely Interpersonal Flexibility - ability to adapt to other personalities in a respectful manner that is conducive to goal achievement Teamwork - the ability to work well in a highly cross-functional team environment Presentation skills - create and deliver presentations with appropriate messaging and focused recommendations. TRAVEL REQUIREMENTS: International travel may be required Ability to attend offsite meetings that may involve overnight stay This position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy. $137,200 to 196,000 based on candidate professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off. This posting is made in compliance with Colorado's Equal Pay for Equal Work Act, C.R.S. 8-5-101 et seq In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
02/08/2023
Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. OBJECTIVE: The Lead International Advertising and Promotion (A&P) serves as an internal expert on International, EFPIA, and regulations, guidance governing the promotion of prescription drug and biologic products and disease awareness activities. The Lead International Advertising and Promotion (A&P) serves as the reviewer for pipeline compounds and as such must have an understanding of the EphMRA Code governing market research activities. Capable of providing regulatory strategic oversight for at least one (1) complex product or therapeutic area/multiple products to help ensure regulatory compliance of promotional and non-promotional materials generated for assigned products and/or compounds. Assists in the development, integration, and implementation of internal policies, work instructions, guidances and regional and LOC specific requirements, in collaboration with the A&P Group Lead. The role serves as the process expert and is the lead for applicable A&P projects to ensure collaboration with key stakeholders and completion as planned. Works collaboratively with colleagues in Regulatory Affairs, Medical, Legal, Commercial and Ethics & Compliance organizations and applies expertise to ensure that the development of promotional and disease state materials is accomplished through compliance with internal processes and standards. Responsible for selected LOC's in a designated region to support the strategy and integration and implementation of the Local review process variations, working instructions and assist in local complaint management in order to ensure consistency with the International processes. Supports the development, integration and implementation of directed and agreed future development and improvement of the global review process, standards . ACCOUNTABILITIES: Evaluates materials to ensure compliance with International regulations, guidance, corporate standards and policies and business objectives. In collaboration with Commercial, Medical and Legal colleagues, conducts a detailed review and evaluation of the adequacy of clinical evidence provided to support proposed claims that are consistent with product labeling. Provides consistent, well-supported, and clear guidance to key stakeholders. Serves as the chair of CMLR review meetings and assists Commercial with the planning and prioritization of proposed promotional and disease state materials. Provides expert guidance related to Regulatory strategy to commerical and key stakeholders during early development of projects to ensure promotional goals can be achieved (e.g., target product profile; clinical trial recruitment materials). Participates in CMLR meetings to resolve potential issues and participates in escalation meetings, as needed. Supports metrics to measure and track effectiveness and efficiency of the CMLR review process; provides recommendations for process improvements to address issues, gains agreement of process improvements from key stakeholders, and helps implement agreed-upon process improvements. Understands broad concepts within regulatory affairs and potential implications across organization. Proactively identifies regulatory issues. Offers creative solutions and strategies, including risk mitigation strategies. Leads internal A&P project workstreams (e.g., guidance documents) and active participant at team staff meetings Being the contact point and expert matter for the promotional review process and International review standards for selected LOC's within the designated region Supports the development, integration and update of the LOC processes and standards for promotional & non-promotional review and ensure full training implementation for selected LOC's within the designated region. Address unmet LOC needs for selected LOC's within the designated region through LOC discussions and the development of online collaboration tools. Being key contact person for selected LOC's within the designated region for complaints regarding promotional or disease awareness materials/activities in the designated region to drive centralisation and global coordination and identify potential competitor trends or risks that require further legal action. Collaborates with the US CMLR review teams for materials that are intended for global audiences (e.g., global press releases, new global campaigns). EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: Required: Bachelor's Degree in a science-related field Ability to understand EFPIA and International (ex-US) regulations basics on advertising and promotion for prescription products Ability to understand the basics in pharmaceutical promotion development and reviewprocess Strong interpersonal skills with ability to demonstrate strategic and analytic thinking Demonstrated ability to clearly and concisely communicate. Effective written and verbal communication skills in order to manage, motivate and drive decisions within teams. Proven skills in negotiation, influencing without authority and working diplomatically through conflict. Ability to work independently, take initiative and complete tasks to deadlines Previous experience in advertising and promotion; experience in managing regulatory filing(s) or competitor complaints or medical communication/information. Desired: Minimum of 2 year experience in International review and approval process of pharmaceutical/biologics promotion Skills: Leadership Skills - ability to effectively manage and bring working teams together for common objectives Strategic Approach - u nderstands the phases, processes and techniques used within a clinical development environment, can contribute to clinical study design discussions as needed. Analytical and Problem-Solving Skills - ability to understand complex issues and propose achievable solutions. Communication Skills - ability to express one's self clearly and concisely Interpersonal Flexibility - ability to adapt to other personalities in a respectful manner that is conducive to goal achievement Teamwork - the ability to work well in a highly cross-functional team environment Presentation skills - create and deliver presentations with appropriate messaging and focused recommendations. TRAVEL REQUIREMENTS: International travel may be required Ability to attend offsite meetings that may involve overnight stay This position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy. $137,200 to 196,000 based on candidate professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off. This posting is made in compliance with Colorado's Equal Pay for Equal Work Act, C.R.S. 8-5-101 et seq In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
The A+ Program is looking for upper level/advance degree students to teach in it's Saturday academic enrichment programs. ASC offers traditional classroom-based teacher-led programs for children in new immigrant communities in the greater Boston area. We teach English and math from grade 2 to high school. We also have AP, ISEE and SAT classes. Finally, we hold writing classes for Elementary, Middle School and High School students. Quailifed candidates will have subject knowledge background with classroom/tutoring experience. Hourly wages: ELA $22 to $27 per hour. Math $25 to $30 per hour. Test prep $27 to $30 per hour
02/08/2023
Full time
The A+ Program is looking for upper level/advance degree students to teach in it's Saturday academic enrichment programs. ASC offers traditional classroom-based teacher-led programs for children in new immigrant communities in the greater Boston area. We teach English and math from grade 2 to high school. We also have AP, ISEE and SAT classes. Finally, we hold writing classes for Elementary, Middle School and High School students. Quailifed candidates will have subject knowledge background with classroom/tutoring experience. Hourly wages: ELA $22 to $27 per hour. Math $25 to $30 per hour. Test prep $27 to $30 per hour
POSITION SUMMARY: Launched in 2010, Northeast Bank's national lending team has grown a $1.3B loan portfolio and continues to expand the platform by providing dynamic commercial real estate lending solutions. As a national lender with deep industry knowledge, the Bank originates traditional and transitional loans and other facilities for borrowers and non-bank lenders, as well as purchases loans originated by third parties. Northeast Bank has earned a reputation for providing creative and responsive lending solutions secured by commercial real estate and is powered by an experienced underwriting team with a successful track record. The successful candidate would be part of the Real Estate Group and will play an active role on the origination and underwriting team, providing valuation expertise for new lending opportunities across real estate sectors nationwide. RESPONSIBILITIES: Commercial Real Estate Valuation - complete internal valuation analyses/reports across a variety of property types and geographies for loans under consideration for purchase and for loans being underwritten for origination. Involves fast paced, independent analysis including the review and synthesis of appraisal, property financials, and other due diligence items; discussions with local market participants; and a survey of market conditions. Present conclusions to Loan Approval Committee / Senior Management Prescreen New Opportunities - review CRE securing new lending opportunities to assess market position and liquidity and develop a view on collateral value and loan to value. Work closely with Relationship Management and Credit Underwriting groups to discuss risks associated with underlying real estate Collaborate & Consult - work closely with the Originators, Credit, Legal, Relationship Management and Asset Management throughout the life cycle of a loan, from due diligence-to closing-to asset management-to disposition. Act as a subject matter expert on all matters related to real estate Travel - when appropriate, complete site inspections for due diligence or asset management purposes Successfully pass technical and regulatory examinations required by the Company. KNOWLEDGE, SKILLS AND ABILITIES: Bachelor's degree with a strong track record of performance and leadership 5 plus years of experience in commercial real estate lending, real estate valuation and/or underwriting Intermediate to advanced Excel skills with knowledge of real estate financial modeling Outstanding interpersonal, verbal, and written communication skills Attention to detail, ability to multi-task and self-motivate in a fast-paced environment Formal bank credit training or continuing education in credit and/or real estate topics a plus PHYSICAL DEMANDS AND CONDITIONS: Must be able to remain in a stationary position for long periods of time. Some travel is required. Must be able to occasionally lift up to 20lbs. Consistently operates a computer and other office machinery such as calculator, copy machine and printers. Climate controlled general office setting with moderate noise level. Must express or exchange ideas and meaning with co-workers, supervisors, customers and vendors. Northeast Bank is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity and expression, national original, veteran status and any other classification protected by Law. We celebrate diversity and are committed to creating an inclusive environment for all employees.
02/08/2023
Full time
POSITION SUMMARY: Launched in 2010, Northeast Bank's national lending team has grown a $1.3B loan portfolio and continues to expand the platform by providing dynamic commercial real estate lending solutions. As a national lender with deep industry knowledge, the Bank originates traditional and transitional loans and other facilities for borrowers and non-bank lenders, as well as purchases loans originated by third parties. Northeast Bank has earned a reputation for providing creative and responsive lending solutions secured by commercial real estate and is powered by an experienced underwriting team with a successful track record. The successful candidate would be part of the Real Estate Group and will play an active role on the origination and underwriting team, providing valuation expertise for new lending opportunities across real estate sectors nationwide. RESPONSIBILITIES: Commercial Real Estate Valuation - complete internal valuation analyses/reports across a variety of property types and geographies for loans under consideration for purchase and for loans being underwritten for origination. Involves fast paced, independent analysis including the review and synthesis of appraisal, property financials, and other due diligence items; discussions with local market participants; and a survey of market conditions. Present conclusions to Loan Approval Committee / Senior Management Prescreen New Opportunities - review CRE securing new lending opportunities to assess market position and liquidity and develop a view on collateral value and loan to value. Work closely with Relationship Management and Credit Underwriting groups to discuss risks associated with underlying real estate Collaborate & Consult - work closely with the Originators, Credit, Legal, Relationship Management and Asset Management throughout the life cycle of a loan, from due diligence-to closing-to asset management-to disposition. Act as a subject matter expert on all matters related to real estate Travel - when appropriate, complete site inspections for due diligence or asset management purposes Successfully pass technical and regulatory examinations required by the Company. KNOWLEDGE, SKILLS AND ABILITIES: Bachelor's degree with a strong track record of performance and leadership 5 plus years of experience in commercial real estate lending, real estate valuation and/or underwriting Intermediate to advanced Excel skills with knowledge of real estate financial modeling Outstanding interpersonal, verbal, and written communication skills Attention to detail, ability to multi-task and self-motivate in a fast-paced environment Formal bank credit training or continuing education in credit and/or real estate topics a plus PHYSICAL DEMANDS AND CONDITIONS: Must be able to remain in a stationary position for long periods of time. Some travel is required. Must be able to occasionally lift up to 20lbs. Consistently operates a computer and other office machinery such as calculator, copy machine and printers. Climate controlled general office setting with moderate noise level. Must express or exchange ideas and meaning with co-workers, supervisors, customers and vendors. Northeast Bank is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity and expression, national original, veteran status and any other classification protected by Law. We celebrate diversity and are committed to creating an inclusive environment for all employees.
