At Genmab, we're committed to building extra not ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose. The Role Genmab is looking for a seasoned leader to head our Clinical Development Data Science team. In this vital role, you will guide the application of data science methodologies to clinical development, with a focus on transforming clinical trial data into actionable insights that enhance patient outcomes and help transform how Genmab develops and brings transformative medicines to patients. If you have a strong background in data science, a passion for helping patients, and experience in clinical development, consider Genmab as the next exciting part of your career journey. We have a hybrid model and require onsite presence 60% of the time in Princeton, NJ. Responsibilities Develop and execute a strategic vision for using data science methodologies to streamline and optimize our clinical development processes and outcomes. Lead a team of data scientists, fostering a culture of innovation, collaboration, and continuous learning. Collaborate closely with cross-functional teams, including Clinical Operations, Regulatory Affairs, Safety, Global Medical Affairs, and Manufacturing to align data science initiatives with broader clinical and business objectives. Oversee the design and implementation of advanced analytical models and algorithms to help analyze complex clinical trial data, ensuring high-quality, actionable outcomes. Keep up-to-date with industry trends and advancements in data science and clinical development, integrating state-of-the-art technologies and techniques into our processes. Communicate complex data science concepts and project outcomes to various stakeholders, both technical and non-technical. Requirements Advanced degree (PhD preferred) in Data Science, Bioinformatics, Biostatistics, or a related field. Minimum of 10 years' experience in data science, with at least 5 years in a leadership role within the biopharma or healthcare industry. Demonstrated experience with Python, R, and data science libraries such as Pandas, NumPy, Scikit-learn, etc. Deep understanding of clinical development processes, with a focus on oncology. Proven track record of applying data science methodologies to enhance clinical trial design, execution, and analysis. Strong leadership and communication skills, with the ability to inspire teams and effectively communicate complex concepts. Experience with Real World Evidence (RWE) and Real World Data (RWD). Familiarity with regulatory standards and practices in the biopharma industry, specifically clinical development. Publications in data science or clinical development conferences/journals is a plus. For US based candidates, the proposed salary band for this position is as follows: $206,250.00 $343,750.00 The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as bonuses. About You You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving You are a generous collaborator who can work in teams with diverse backgrounds You are determined to do and be your best and take pride in enabling the best work of others on the team You are not afraid to grapple with the unknown and be innovative You have experience working in a fast-growing, dynamic company (or a strong desire to) You work hard and are not afraid to have a little fun while you do so Locations Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you're in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate. About Genmab Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan. Our commitment to diversity, equity, and inclusion We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on our website. Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.
04/18/2024
Full time
At Genmab, we're committed to building extra not ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose. The Role Genmab is looking for a seasoned leader to head our Clinical Development Data Science team. In this vital role, you will guide the application of data science methodologies to clinical development, with a focus on transforming clinical trial data into actionable insights that enhance patient outcomes and help transform how Genmab develops and brings transformative medicines to patients. If you have a strong background in data science, a passion for helping patients, and experience in clinical development, consider Genmab as the next exciting part of your career journey. We have a hybrid model and require onsite presence 60% of the time in Princeton, NJ. Responsibilities Develop and execute a strategic vision for using data science methodologies to streamline and optimize our clinical development processes and outcomes. Lead a team of data scientists, fostering a culture of innovation, collaboration, and continuous learning. Collaborate closely with cross-functional teams, including Clinical Operations, Regulatory Affairs, Safety, Global Medical Affairs, and Manufacturing to align data science initiatives with broader clinical and business objectives. Oversee the design and implementation of advanced analytical models and algorithms to help analyze complex clinical trial data, ensuring high-quality, actionable outcomes. Keep up-to-date with industry trends and advancements in data science and clinical development, integrating state-of-the-art technologies and techniques into our processes. Communicate complex data science concepts and project outcomes to various stakeholders, both technical and non-technical. Requirements Advanced degree (PhD preferred) in Data Science, Bioinformatics, Biostatistics, or a related field. Minimum of 10 years' experience in data science, with at least 5 years in a leadership role within the biopharma or healthcare industry. Demonstrated experience with Python, R, and data science libraries such as Pandas, NumPy, Scikit-learn, etc. Deep understanding of clinical development processes, with a focus on oncology. Proven track record of applying data science methodologies to enhance clinical trial design, execution, and analysis. Strong leadership and communication skills, with the ability to inspire teams and effectively communicate complex concepts. Experience with Real World Evidence (RWE) and Real World Data (RWD). Familiarity with regulatory standards and practices in the biopharma industry, specifically clinical development. Publications in data science or clinical development conferences/journals is a plus. For US based candidates, the proposed salary band for this position is as follows: $206,250.00 $343,750.00 The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as bonuses. About You You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving You are a generous collaborator who can work in teams with diverse backgrounds You are determined to do and be your best and take pride in enabling the best work of others on the team You are not afraid to grapple with the unknown and be innovative You have experience working in a fast-growing, dynamic company (or a strong desire to) You work hard and are not afraid to have a little fun while you do so Locations Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you're in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate. About Genmab Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan. Our commitment to diversity, equity, and inclusion We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on our website. Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.
Baylor Scott & White Medical Center Frisco is searching to hire a Director of Quality Management - $10,000 sign-on bonus. The Department Director is responsible for all quality departmental functions in support of the hospital mission, vision, and facility goals. Identifies the cost-effective systems needed to support the business of the department taking into account business trends, resource availability and changes in customers. Establishes effective working relationships with all constituencies including patients, physicians, employees and vendors. Identifies and remedies through continuous clinical outcome data and employee involvement. The Director has the responsibility and authority of planning, organizing, controlling, coordinating and evaluating the activities and functions of the Quality Management Department. This position is responsible for assisting the Vice President, Medical Staff Affairs and the Manager of Peer Review to oversee the Medical Staff Peer Review process. This position also consults with administration on Risk Management issues. Required Skills: Position Qualifications: Current license as a Registered Nurse in Texas. BSN Preferred. One to three years' experience in Quality/Resource Management. Relevant clinical experience and previous management experience preferred. Knowledge of hospital organizations, committees, department functions, and Performance Improvement activities. Demonstrate competent administrative, communication and leadership skills. Knowledge of Joint Commission, Medicare, and TDSHS standards a must. Basic computer knowledge. Word Perfect, Word, and Excel required. Possess the ability to make independent decisions, and handle multiple projects simultaneously. Position Responsibilities: Develops and implements metrics and performance targets that assess compliance with CMS, TJC and ISDH regulations and best practices in medical management. Coordinates improvement activities for successful accrediting, licensing and certification surveys (e.g., Joint Commission, Department of Health, Centers for Medicare/Medicaid Services). Assists with audits of medical staff for compliance with policies and procedures and with regulatory and accreditation requirements. Utilizes quality assurance and quality improvement evaluation methodologies for measurement of protocol compliance and to sustain survey readiness, including ongoing preparedness reviews. Analyzes data to determine trends and resource utilization for use in optimizing compliance and to prepare reports describing individual performance. Identifies through the analysis process a summary of issues and/or policies that have the potential to negatively impact clinical outcomes and/or the delivery of quality healthcare. Assists in the education of providers in the importance of following the documentation guidelines that have been established in accordance with state, Federal regulatory and accreditation requirements. Collaborates in the implementation, monitoring and reassessment of quality improvement plans. Maintains working knowledge of CMS, TJC, ISDH and HIPAA regulation standards as pertinent to the organization. Maintains the goals and objectives of the Quality Improvement Program in line with the Hospital's Mission and goals. Monitors cases to identify trends and emerging issues and presents to quality improvement committee. Conducts focused examination of conditions requiring correction and develop a precise definition of the problem. Coordinates with providers to communicate and ensure adherence to healthcare quality management guidelines. Assists in the development of improvement plans with department/unit managers and supervisors in response to identified deficiencies. Maintains documentation related to oversight including schedules/calendars of audits and monitoring activities and electronic and/or paper copies of audits and follow-up activities. Establishes/maintains good relationships with CEO, CFO/COO, CNO and department leaders to promote a cooperative and constructive environment for improvement. Other duties as assigned. Employment practices will not be influenced or affected by an applicant's or employee's race, color, religion, sex (including pregnancy), national origin, age, disability, genetic information, sexual orientation, gender identity or expression, veteran status or any other legally protected status. Tenet will make reasonable accommodations for qualified individuals with disabilities unless doing so would result in an undue hardship.
04/18/2024
Full time
Baylor Scott & White Medical Center Frisco is searching to hire a Director of Quality Management - $10,000 sign-on bonus. The Department Director is responsible for all quality departmental functions in support of the hospital mission, vision, and facility goals. Identifies the cost-effective systems needed to support the business of the department taking into account business trends, resource availability and changes in customers. Establishes effective working relationships with all constituencies including patients, physicians, employees and vendors. Identifies and remedies through continuous clinical outcome data and employee involvement. The Director has the responsibility and authority of planning, organizing, controlling, coordinating and evaluating the activities and functions of the Quality Management Department. This position is responsible for assisting the Vice President, Medical Staff Affairs and the Manager of Peer Review to oversee the Medical Staff Peer Review process. This position also consults with administration on Risk Management issues. Required Skills: Position Qualifications: Current license as a Registered Nurse in Texas. BSN Preferred. One to three years' experience in Quality/Resource Management. Relevant clinical experience and previous management experience preferred. Knowledge of hospital organizations, committees, department functions, and Performance Improvement activities. Demonstrate competent administrative, communication and leadership skills. Knowledge of Joint Commission, Medicare, and TDSHS standards a must. Basic computer knowledge. Word Perfect, Word, and Excel required. Possess the ability to make independent decisions, and handle multiple projects simultaneously. Position Responsibilities: Develops and implements metrics and performance targets that assess compliance with CMS, TJC and ISDH regulations and best practices in medical management. Coordinates improvement activities for successful accrediting, licensing and certification surveys (e.g., Joint Commission, Department of Health, Centers for Medicare/Medicaid Services). Assists with audits of medical staff for compliance with policies and procedures and with regulatory and accreditation requirements. Utilizes quality assurance and quality improvement evaluation methodologies for measurement of protocol compliance and to sustain survey readiness, including ongoing preparedness reviews. Analyzes data to determine trends and resource utilization for use in optimizing compliance and to prepare reports describing individual performance. Identifies through the analysis process a summary of issues and/or policies that have the potential to negatively impact clinical outcomes and/or the delivery of quality healthcare. Assists in the education of providers in the importance of following the documentation guidelines that have been established in accordance with state, Federal regulatory and accreditation requirements. Collaborates in the implementation, monitoring and reassessment of quality improvement plans. Maintains working knowledge of CMS, TJC, ISDH and HIPAA regulation standards as pertinent to the organization. Maintains the goals and objectives of the Quality Improvement Program in line with the Hospital's Mission and goals. Monitors cases to identify trends and emerging issues and presents to quality improvement committee. Conducts focused examination of conditions requiring correction and develop a precise definition of the problem. Coordinates with providers to communicate and ensure adherence to healthcare quality management guidelines. Assists in the development of improvement plans with department/unit managers and supervisors in response to identified deficiencies. Maintains documentation related to oversight including schedules/calendars of audits and monitoring activities and electronic and/or paper copies of audits and follow-up activities. Establishes/maintains good relationships with CEO, CFO/COO, CNO and department leaders to promote a cooperative and constructive environment for improvement. Other duties as assigned. Employment practices will not be influenced or affected by an applicant's or employee's race, color, religion, sex (including pregnancy), national origin, age, disability, genetic information, sexual orientation, gender identity or expression, veteran status or any other legally protected status. Tenet will make reasonable accommodations for qualified individuals with disabilities unless doing so would result in an undue hardship.
Baylor Scott & White Medical Center Frisco is searching to hire a Director of Quality Management - $10,000 sign-on bonus. The Department Director is responsible for all quality departmental functions in support of the hospital mission, vision, and facility goals. Identifies the cost-effective systems needed to support the business of the department taking into account business trends, resource availability and changes in customers. Establishes effective working relationships with all constituencies including patients, physicians, employees and vendors. Identifies and remedies through continuous clinical outcome data and employee involvement. The Director has the responsibility and authority of planning, organizing, controlling, coordinating and evaluating the activities and functions of the Quality Management Department. This position is responsible for assisting the Vice President, Medical Staff Affairs and the Manager of Peer Review to oversee the Medical Staff Peer Review process. This position also consults with administration on Risk Management issues. Required Skills: Position Qualifications: Current license as a Registered Nurse in Texas. BSN Preferred. One to three years' experience in Quality/Resource Management. Relevant clinical experience and previous management experience preferred. Knowledge of hospital organizations, committees, department functions, and Performance Improvement activities. Demonstrate competent administrative, communication and leadership skills. Knowledge of Joint Commission, Medicare, and TDSHS standards a must. Basic computer knowledge. Word Perfect, Word, and Excel required. Possess the ability to make independent decisions, and handle multiple projects simultaneously. Position Responsibilities: Develops and implements metrics and performance targets that assess compliance with CMS, TJC and ISDH regulations and best practices in medical management. Coordinates improvement activities for successful accrediting, licensing and certification surveys (e.g., Joint Commission, Department of Health, Centers for Medicare/Medicaid Services). Assists with audits of medical staff for compliance with policies and procedures and with regulatory and accreditation requirements. Utilizes quality assurance and quality improvement evaluation methodologies for measurement of protocol compliance and to sustain survey readiness, including ongoing preparedness reviews. Analyzes data to determine trends and resource utilization for use in optimizing compliance and to prepare reports describing individual performance. Identifies through the analysis process a summary of issues and/or policies that have the potential to negatively impact clinical outcomes and/or the delivery of quality healthcare. Assists in the education of providers in the importance of following the documentation guidelines that have been established in accordance with state, Federal regulatory and accreditation requirements. Collaborates in the implementation, monitoring and reassessment of quality improvement plans. Maintains working knowledge of CMS, TJC, ISDH and HIPAA regulation standards as pertinent to the organization. Maintains the goals and objectives of the Quality Improvement Program in line with the Hospital's Mission and goals. Monitors cases to identify trends and emerging issues and presents to quality improvement committee. Conducts focused examination of conditions requiring correction and develop a precise definition of the problem. Coordinates with providers to communicate and ensure adherence to healthcare quality management guidelines. Assists in the development of improvement plans with department/unit managers and supervisors in response to identified deficiencies. Maintains documentation related to oversight including schedules/calendars of audits and monitoring activities and electronic and/or paper copies of audits and follow-up activities. Establishes/maintains good relationships with CEO, CFO/COO, CNO and department leaders to promote a cooperative and constructive environment for improvement. Other duties as assigned. Employment practices will not be influenced or affected by an applicant's or employee's race, color, religion, sex (including pregnancy), national origin, age, disability, genetic information, sexual orientation, gender identity or expression, veteran status or any other legally protected status. Tenet will make reasonable accommodations for qualified individuals with disabilities unless doing so would result in an undue hardship.
04/17/2024
Full time
Baylor Scott & White Medical Center Frisco is searching to hire a Director of Quality Management - $10,000 sign-on bonus. The Department Director is responsible for all quality departmental functions in support of the hospital mission, vision, and facility goals. Identifies the cost-effective systems needed to support the business of the department taking into account business trends, resource availability and changes in customers. Establishes effective working relationships with all constituencies including patients, physicians, employees and vendors. Identifies and remedies through continuous clinical outcome data and employee involvement. The Director has the responsibility and authority of planning, organizing, controlling, coordinating and evaluating the activities and functions of the Quality Management Department. This position is responsible for assisting the Vice President, Medical Staff Affairs and the Manager of Peer Review to oversee the Medical Staff Peer Review process. This position also consults with administration on Risk Management issues. Required Skills: Position Qualifications: Current license as a Registered Nurse in Texas. BSN Preferred. One to three years' experience in Quality/Resource Management. Relevant clinical experience and previous management experience preferred. Knowledge of hospital organizations, committees, department functions, and Performance Improvement activities. Demonstrate competent administrative, communication and leadership skills. Knowledge of Joint Commission, Medicare, and TDSHS standards a must. Basic computer knowledge. Word Perfect, Word, and Excel required. Possess the ability to make independent decisions, and handle multiple projects simultaneously. Position Responsibilities: Develops and implements metrics and performance targets that assess compliance with CMS, TJC and ISDH regulations and best practices in medical management. Coordinates improvement activities for successful accrediting, licensing and certification surveys (e.g., Joint Commission, Department of Health, Centers for Medicare/Medicaid Services). Assists with audits of medical staff for compliance with policies and procedures and with regulatory and accreditation requirements. Utilizes quality assurance and quality improvement evaluation methodologies for measurement of protocol compliance and to sustain survey readiness, including ongoing preparedness reviews. Analyzes data to determine trends and resource utilization for use in optimizing compliance and to prepare reports describing individual performance. Identifies through the analysis process a summary of issues and/or policies that have the potential to negatively impact clinical outcomes and/or the delivery of quality healthcare. Assists in the education of providers in the importance of following the documentation guidelines that have been established in accordance with state, Federal regulatory and accreditation requirements. Collaborates in the implementation, monitoring and reassessment of quality improvement plans. Maintains working knowledge of CMS, TJC, ISDH and HIPAA regulation standards as pertinent to the organization. Maintains the goals and objectives of the Quality Improvement Program in line with the Hospital's Mission and goals. Monitors cases to identify trends and emerging issues and presents to quality improvement committee. Conducts focused examination of conditions requiring correction and develop a precise definition of the problem. Coordinates with providers to communicate and ensure adherence to healthcare quality management guidelines. Assists in the development of improvement plans with department/unit managers and supervisors in response to identified deficiencies. Maintains documentation related to oversight including schedules/calendars of audits and monitoring activities and electronic and/or paper copies of audits and follow-up activities. Establishes/maintains good relationships with CEO, CFO/COO, CNO and department leaders to promote a cooperative and constructive environment for improvement. Other duties as assigned. Employment practices will not be influenced or affected by an applicant's or employee's race, color, religion, sex (including pregnancy), national origin, age, disability, genetic information, sexual orientation, gender identity or expression, veteran status or any other legally protected status. Tenet will make reasonable accommodations for qualified individuals with disabilities unless doing so would result in an undue hardship.
Department/Unit: Practice Administration Work Shift: Day (United States of America) Practice Administrator, Albany OBGYN Office This position serves as the business and operations leader of the Department. Ensures effective communication and implementation of institutional strategies and initiatives throughout all layers of department staff. Provide hands-on leadership to Practice Managers and other department managers to ensure all aspects of the operations including patient relations, staffing, marketing, insurance, and financial activities are successfully managed. Maintains pristine communication channels with the Chair and other Department leaders regarding impact of decisions, strategy and tactics of global financial picture, divisional financial picture, status of specific projects and advises Chair of potential Department problems. Responsible to ensure all department staff and activities are aligned to help the practice achieve the institutional mission of high quality provision of care for patients. REQUIREMENTS AND PREFERENCES: A Bachelor's degree is required; MBA or MHA strongly preferred. Proven ability to lead with a minimum of five years of experience in medical practice administration or health care operations; three years of experience if candidate has achieved the MBA/MHA degree. Must project a professional image and earn the confidence of a broad range of internal and external resources. Must have pristine verbal and written communication skills and have experience in and a desire to deal professionally with the public. Exceptional interpersonal and relationship-building skills are required. To be able to develop leaders and facilitate groups of individuals that emphasizes quality, continuous improvement, and high performance. Must possess a high level of critical and ethical thinking/behavior and be able to deal with difficult situations with a high level of emotional intelligence. Must not only be self-motivated, have swift learning ability and a "can-do," optimistic attitude, but also be able to draw out and develop these characteristics in others. An excellent working knowledge of personal computers, word-processing and spreadsheet software (such as the Microsoft Suite) is required as well as excellent keyboarding skills. Experience with medical recordkeeping and billing system is strongly preferred. Sharp accounting and financial skills and strong problem-solving skills are required. Must be HIPAA compliant at all times. Salary Range: $80,151.00/annually - $132,249.00/annually ACCOUNTABILITIES: Human Resources Works to achieve the ambitious practice goals for operational metrics and establishes priorities with clear responsibilities to ensure results; manages projects, activities and resources effectively. Serves as a mentor to clinic managers and staff offering development, coaching and assuring competency and accountability. Ensure timely completion of annual Competency Assessments and Performance Evaluations, providing effective coaching and mentoring of staff in the development of goals that are in alignment with the overall institutional goals. Act as central spokesperson and provide supervision of providers, staff and vendors. Provide appropriate level of guidance, coaching, and mentoring to Practice and Department managers and staff by giving appropriate feedback on job performance to all direct reports Develop new provider business plans and actively recruit, interview, select and onboard provider and management staff. Ensure that practice managers and supervisors provide timely and appropriate performance feedback to all Departmental employees. Utilize Practice performance measurement systems to help managers and staff ensure that their day-to-day decisions/activities reflect long-term strategic goals. Oversee the MD employment agreement process for the Department to ensure that all formal agreements are appropriate, and assist with the development of all other Departmental contractual agreements as requested. Oversee and manage the residency and student education programs and resources within the Department. Ensure compliance of all staff requirements including annual health assessments, annual competency assessments, and appropriate training and education. Financial and Metrics Budget Works with the Department Chair to develop and manage (in collaboration with the Director of Practice Finance) the Department's annual operating budget and assesses Department's annual capital needs. Administrator and Chair are to report monthly on variances to budget Practice President. Manage unit revenue through development of operational capacity and patient access to enhance service productivity and an improved payer mix. Develop and formulate business plans for the Department or Division. Responsible for budgetary control of the practice activities within the Department; responsibility includes oversight of projected revenues, expenses and salaries. Support the organization's financial position by helping managers and physicians understand the financial consequence of their tactics and decisions. Implement and monitor the strategic business plans once approved by the Dean and the Operating Committee of the practice. Utilize reports effectively to optimize operations within the department and drive quality and financial results. In collaboration with Faculty Practice Leadership, identify, develop and implement practice-wide reporting metrics, measurements, monitoring and auditing. With the Department Chair or Division Chief, propose, develop and operationalize strategic business plans for the Department in alignment with institutional goals and objectives. In coordination with the Department Chair, Division Chief, and Vice Dean of Clinical Affairs, develop and annually update a Department or Division three-year strategic plan. Enhance core processes for gathering, analyzing and sharing information ensuring timely preparation of operations forecasts and analyses as requested. Operations Management In collaboration with the physician leadership, benchmark to premier healthcare organizations nationally, identify and apply the best operational practices that reduce variability and improve the efficiency of the Department. Develops operational capacity and patient access to enhance service development and an improved patient mix. Identify efficiencies and deficiencies of programs to determine if they are essential plans, recommend and implement changes or solutions. Provides project management leadership for multiple strategic and operational initiatives (i.e. acquisitions, mergers, patient mix, facility analysis, TJC, Scope of Practice issues). Works to achieve practice goals for operational metrics and establishes priorities with clear responsibilities to ensure results; manages projects, activities and resources effectively. Implement and enforce the standards and requirements necessary to maintain state, local and accreditation standards. Demonstrate knowledge of key critical operational areas within each Department. Establish protocols including regular auditing to manage failures of those critical areas Promote and develop systems within the department, which improve the efficiencies in service scheduling, access and care delivery. Responsible for overseeing of the daily on-going operations of the department as well as coordination of activities with other Departments and managers. In conjunction with the Practice Administration Team, responsible for the development, implementation, monitoring and subsequent review of policies and procedures related to the clinical and operational support functions of the Department. Solicit and collect management's recommendations for job description changes, task allocation and compensation and deliver to Director of Operations quarterly. Report on Department activities to the Department Chief and Administrator Team on a weekly basis. Responsible for the Department sites meeting all regulatory requirements including but not limited to TJC and other regulatory authorities. Represent the site as an integrated program in all areas of the Institution. Develop, promote, and maintain open communications with all Faculty Practice Administrators, Department Chairs, provider and support staff, service vendors, and patients. Patient Satisfaction Manage elevated patient grievances and coordinate service recovery efforts when needed. Ensure fiscal and operational activities are performed in such a manner that they are aligned patient satisfaction. Working in an interdisciplinary fashion, champions the development of "the exceptional patient experience". This experience aims to improve the access to the operational efficiency of and the satisfaction with the patient's interaction with the Practice. Responsible for understanding consumer service issues within the Department and continually working on tactics to improve patient satisfaction. Resolve any patient grievances utilizing appropriate methods and using Albany Med Cares Service Recovery toolkit as necessary. Participate in Patient Grievance Meetings as required. Management Support and Other Tasks Actively participate in practice-wide and institution-wide initiatives and projects. . click apply for full job details
04/16/2024
Full time
Department/Unit: Practice Administration Work Shift: Day (United States of America) Practice Administrator, Albany OBGYN Office This position serves as the business and operations leader of the Department. Ensures effective communication and implementation of institutional strategies and initiatives throughout all layers of department staff. Provide hands-on leadership to Practice Managers and other department managers to ensure all aspects of the operations including patient relations, staffing, marketing, insurance, and financial activities are successfully managed. Maintains pristine communication channels with the Chair and other Department leaders regarding impact of decisions, strategy and tactics of global financial picture, divisional financial picture, status of specific projects and advises Chair of potential Department problems. Responsible to ensure all department staff and activities are aligned to help the practice achieve the institutional mission of high quality provision of care for patients. REQUIREMENTS AND PREFERENCES: A Bachelor's degree is required; MBA or MHA strongly preferred. Proven ability to lead with a minimum of five years of experience in medical practice administration or health care operations; three years of experience if candidate has achieved the MBA/MHA degree. Must project a professional image and earn the confidence of a broad range of internal and external resources. Must have pristine verbal and written communication skills and have experience in and a desire to deal professionally with the public. Exceptional interpersonal and relationship-building skills are required. To be able to develop leaders and facilitate groups of individuals that emphasizes quality, continuous improvement, and high performance. Must possess a high level of critical and ethical thinking/behavior and be able to deal with difficult situations with a high level of emotional intelligence. Must not only be self-motivated, have swift learning ability and a "can-do," optimistic attitude, but also be able to draw out and develop these characteristics in others. An excellent working knowledge of personal computers, word-processing and spreadsheet software (such as the Microsoft Suite) is required as well as excellent keyboarding skills. Experience with medical recordkeeping and billing system is strongly preferred. Sharp accounting and financial skills and strong problem-solving skills are required. Must be HIPAA compliant at all times. Salary Range: $80,151.00/annually - $132,249.00/annually ACCOUNTABILITIES: Human Resources Works to achieve the ambitious practice goals for operational metrics and establishes priorities with clear responsibilities to ensure results; manages projects, activities and resources effectively. Serves as a mentor to clinic managers and staff offering development, coaching and assuring competency and accountability. Ensure timely completion of annual Competency Assessments and Performance Evaluations, providing effective coaching and mentoring of staff in the development of goals that are in alignment with the overall institutional goals. Act as central spokesperson and provide supervision of providers, staff and vendors. Provide appropriate level of guidance, coaching, and mentoring to Practice and Department managers and staff by giving appropriate feedback on job performance to all direct reports Develop new provider business plans and actively recruit, interview, select and onboard provider and management staff. Ensure that practice managers and supervisors provide timely and appropriate performance feedback to all Departmental employees. Utilize Practice performance measurement systems to help managers and staff ensure that their day-to-day decisions/activities reflect long-term strategic goals. Oversee the MD employment agreement process for the Department to ensure that all formal agreements are appropriate, and assist with the development of all other Departmental contractual agreements as requested. Oversee and manage the residency and student education programs and resources within the Department. Ensure compliance of all staff requirements including annual health assessments, annual competency assessments, and appropriate training and education. Financial and Metrics Budget Works with the Department Chair to develop and manage (in collaboration with the Director of Practice Finance) the Department's annual operating budget and assesses Department's annual capital needs. Administrator and Chair are to report monthly on variances to budget Practice President. Manage unit revenue through development of operational capacity and patient access to enhance service productivity and an improved payer mix. Develop and formulate business plans for the Department or Division. Responsible for budgetary control of the practice activities within the Department; responsibility includes oversight of projected revenues, expenses and salaries. Support the organization's financial position by helping managers and physicians understand the financial consequence of their tactics and decisions. Implement and monitor the strategic business plans once approved by the Dean and the Operating Committee of the practice. Utilize reports effectively to optimize operations within the department and drive quality and financial results. In collaboration with Faculty Practice Leadership, identify, develop and implement practice-wide reporting metrics, measurements, monitoring and auditing. With the Department Chair or Division Chief, propose, develop and operationalize strategic business plans for the Department in alignment with institutional goals and objectives. In coordination with the Department Chair, Division Chief, and Vice Dean of Clinical Affairs, develop and annually update a Department or Division three-year strategic plan. Enhance core processes for gathering, analyzing and sharing information ensuring timely preparation of operations forecasts and analyses as requested. Operations Management In collaboration with the physician leadership, benchmark to premier healthcare organizations nationally, identify and apply the best operational practices that reduce variability and improve the efficiency of the Department. Develops operational capacity and patient access to enhance service development and an improved patient mix. Identify efficiencies and deficiencies of programs to determine if they are essential plans, recommend and implement changes or solutions. Provides project management leadership for multiple strategic and operational initiatives (i.e. acquisitions, mergers, patient mix, facility analysis, TJC, Scope of Practice issues). Works to achieve practice goals for operational metrics and establishes priorities with clear responsibilities to ensure results; manages projects, activities and resources effectively. Implement and enforce the standards and requirements necessary to maintain state, local and accreditation standards. Demonstrate knowledge of key critical operational areas within each Department. Establish protocols including regular auditing to manage failures of those critical areas Promote and develop systems within the department, which improve the efficiencies in service scheduling, access and care delivery. Responsible for overseeing of the daily on-going operations of the department as well as coordination of activities with other Departments and managers. In conjunction with the Practice Administration Team, responsible for the development, implementation, monitoring and subsequent review of policies and procedures related to the clinical and operational support functions of the Department. Solicit and collect management's recommendations for job description changes, task allocation and compensation and deliver to Director of Operations quarterly. Report on Department activities to the Department Chief and Administrator Team on a weekly basis. Responsible for the Department sites meeting all regulatory requirements including but not limited to TJC and other regulatory authorities. Represent the site as an integrated program in all areas of the Institution. Develop, promote, and maintain open communications with all Faculty Practice Administrators, Department Chairs, provider and support staff, service vendors, and patients. Patient Satisfaction Manage elevated patient grievances and coordinate service recovery efforts when needed. Ensure fiscal and operational activities are performed in such a manner that they are aligned patient satisfaction. Working in an interdisciplinary fashion, champions the development of "the exceptional patient experience". This experience aims to improve the access to the operational efficiency of and the satisfaction with the patient's interaction with the Practice. Responsible for understanding consumer service issues within the Department and continually working on tactics to improve patient satisfaction. Resolve any patient grievances utilizing appropriate methods and using Albany Med Cares Service Recovery toolkit as necessary. Participate in Patient Grievance Meetings as required. Management Support and Other Tasks Actively participate in practice-wide and institution-wide initiatives and projects. . click apply for full job details
Mid-Atlantic Region Commission on Higher Education
Philadelphia, Pennsylvania
Senior Vice President for Legal Affairs and General Counsel The Middle States Commission on Higher Education (MSCHE), an institutional accreditor, invites inquiries, nominations, and applications for the position of Senior Vice President for Legal Affairs and General Counsel. Middle States Commission on Higher Education: MSCHE, located in Philadelphia, PA, is a voluntary, non-governmental, membership association that defines, maintains, and promotes educational excellence across institutions with diverse missions, student populations, and resources. MSCHE is recognized as an institutional accreditor by the U.S. Secretary of Education and the Council on Higher Education Accreditation (CHEA). Senior Vice President for Legal Affairs and General Counsel: Under the supervision of the President, the incumbent of this position will support a broad range of legal activities within the organization. The incumbent in this position will manage and assess legal risks and ensure the appropriate management of complex legal and regulatory matters that arise from the organization and from the business of accrediting colleges and universities. The incumbent in this position will support personnel-related matters and serve as a resource for human resource staff. The management of subpoenas and other legal notices will be expected of the incumbent, and the review of documents and contracts will be necessary to best support the work of the organization. The Senior Vice President for Legal Affairs and General Counsel will oversee and manage the Commission's legal aspects of the complex substantive change process in accordance with federal regulation as well as Commission policy and procedures, which require legal review, more in-depth evaluation, and often reflect changes in legal status, form of control, or ownership. Working with other staff, proposing appropriate action language, and supporting the breadth of the review will be critical. The incumbent will also provide counsel to the President on any institutional matter that reflects other high-level risks for the organization. The Senior Vice President for Legal Affairs and General Counsel is expected to remain knowledgeable of applicable federal and state regulations, Commission policy and procedures, and legal trends that could impact the organization or its accreditation activities. Participation in policy discussions with staff, the Commission, and through other opportunities at regional or national events as requested by the President will be expected. The Senior Vice President for Legal Affairs and General Counsel will serve as an organizational leader and provide energetic and positive interactions with staff, Commissioners, member institutions, peer evaluators, and all constituents through exceptional customer service and communication skills. This is a Full time exempt, remote teleworking position, but does require onsite presence in Philadelphia, PA, and other locations when necessary to fulfill the work of the Commission. The incumbent is expected to travel to and represent the Commission at regional, national, and international events and conferences, funding permitting. This position offers a competitive salary with excellent benefits and work environment. Other Responsibilities include: Legal Support and Advice on Organizational Matters; Legal Advice on Institutional Matters; and Joining the Executive Leadership Team and Cabinet and actively support and participate within the Commission's activities. Minimum Qualifications: Juris doctor degree from an ABA-accredited law school; A minimum of three years of legal experience; Licensed and in good standing to practice law in the Commonwealth of Pennsylvania or eligible for immediate licensure; Broad legal experience across a range of areas, including labor law, contract law, corporate transactions, antitrust compliance, and general non-profit laws and principles; Broad-based legal experience and knowledge of higher education and/or with non-profit organizations; Demonstrated experience working with a governing board; Demonstrated general legal experience in the areas needed to support the position; Demonstrated knowledge and understanding of the legal issues confronting colleges and universities, including those from a regulatory perspective; Knowledge or experience in international law and/or antitrust law would be beneficial to the position; Exceptional verbal, written, and customer service skills, with demonstrated ability to work independently as well as collaboratively in a team environment; Demonstrated technology skills needed for the position, with the flexibility to adapt to changing technology as necessary; and Exceptional analytical, interpersonal, research, and organizational skills. For more information on MSCHE and the position, including additional responsibilities and a full list of qualifications, please email (see below) How to Apply: Inquiries, nominations, and applications may be sent to: . Applications should include: 1) a detailed letter of interest; 2) a current resume; and 3) a list of five professional references with contact information. References will not be contacted without permission from the candidate. Please submit applications by October 10, 2021. Late or incomplete applications may not be considered. MSCHE is an Equal Employment Opportunity employer and complies with all applicable federal, state, and local fair employment practices laws. MSCHE strictly prohibits and does not tolerate unlawful discrimination against employees, applicants, or any other covered persons on the basis of protected class membership. For information please visit, The Chronicle of Higher Education. Keywords: VP Legal Affairs, Location: Philadelphia, PA - 19104
09/25/2021
Full time
Senior Vice President for Legal Affairs and General Counsel The Middle States Commission on Higher Education (MSCHE), an institutional accreditor, invites inquiries, nominations, and applications for the position of Senior Vice President for Legal Affairs and General Counsel. Middle States Commission on Higher Education: MSCHE, located in Philadelphia, PA, is a voluntary, non-governmental, membership association that defines, maintains, and promotes educational excellence across institutions with diverse missions, student populations, and resources. MSCHE is recognized as an institutional accreditor by the U.S. Secretary of Education and the Council on Higher Education Accreditation (CHEA). Senior Vice President for Legal Affairs and General Counsel: Under the supervision of the President, the incumbent of this position will support a broad range of legal activities within the organization. The incumbent in this position will manage and assess legal risks and ensure the appropriate management of complex legal and regulatory matters that arise from the organization and from the business of accrediting colleges and universities. The incumbent in this position will support personnel-related matters and serve as a resource for human resource staff. The management of subpoenas and other legal notices will be expected of the incumbent, and the review of documents and contracts will be necessary to best support the work of the organization. The Senior Vice President for Legal Affairs and General Counsel will oversee and manage the Commission's legal aspects of the complex substantive change process in accordance with federal regulation as well as Commission policy and procedures, which require legal review, more in-depth evaluation, and often reflect changes in legal status, form of control, or ownership. Working with other staff, proposing appropriate action language, and supporting the breadth of the review will be critical. The incumbent will also provide counsel to the President on any institutional matter that reflects other high-level risks for the organization. The Senior Vice President for Legal Affairs and General Counsel is expected to remain knowledgeable of applicable federal and state regulations, Commission policy and procedures, and legal trends that could impact the organization or its accreditation activities. Participation in policy discussions with staff, the Commission, and through other opportunities at regional or national events as requested by the President will be expected. The Senior Vice President for Legal Affairs and General Counsel will serve as an organizational leader and provide energetic and positive interactions with staff, Commissioners, member institutions, peer evaluators, and all constituents through exceptional customer service and communication skills. This is a Full time exempt, remote teleworking position, but does require onsite presence in Philadelphia, PA, and other locations when necessary to fulfill the work of the Commission. The incumbent is expected to travel to and represent the Commission at regional, national, and international events and conferences, funding permitting. This position offers a competitive salary with excellent benefits and work environment. Other Responsibilities include: Legal Support and Advice on Organizational Matters; Legal Advice on Institutional Matters; and Joining the Executive Leadership Team and Cabinet and actively support and participate within the Commission's activities. Minimum Qualifications: Juris doctor degree from an ABA-accredited law school; A minimum of three years of legal experience; Licensed and in good standing to practice law in the Commonwealth of Pennsylvania or eligible for immediate licensure; Broad legal experience across a range of areas, including labor law, contract law, corporate transactions, antitrust compliance, and general non-profit laws and principles; Broad-based legal experience and knowledge of higher education and/or with non-profit organizations; Demonstrated experience working with a governing board; Demonstrated general legal experience in the areas needed to support the position; Demonstrated knowledge and understanding of the legal issues confronting colleges and universities, including those from a regulatory perspective; Knowledge or experience in international law and/or antitrust law would be beneficial to the position; Exceptional verbal, written, and customer service skills, with demonstrated ability to work independently as well as collaboratively in a team environment; Demonstrated technology skills needed for the position, with the flexibility to adapt to changing technology as necessary; and Exceptional analytical, interpersonal, research, and organizational skills. For more information on MSCHE and the position, including additional responsibilities and a full list of qualifications, please email (see below) How to Apply: Inquiries, nominations, and applications may be sent to: . Applications should include: 1) a detailed letter of interest; 2) a current resume; and 3) a list of five professional references with contact information. References will not be contacted without permission from the candidate. Please submit applications by October 10, 2021. Late or incomplete applications may not be considered. MSCHE is an Equal Employment Opportunity employer and complies with all applicable federal, state, and local fair employment practices laws. MSCHE strictly prohibits and does not tolerate unlawful discrimination against employees, applicants, or any other covered persons on the basis of protected class membership. For information please visit, The Chronicle of Higher Education. Keywords: VP Legal Affairs, Location: Philadelphia, PA - 19104
Spirit of America Federal Credit Union
Lincoln, Nebraska
SPIRIT OF AMERICA FEDERAL CREDIT UNION General Summary: Responsible for Credit Union Accounting Records; Reporting to Government Agencies and Vendors; Liaison to Data Processor; Security; Regulatory Compliance. Credit Union experience (or financial institution) Required for Experience. Responsible for assisting the Credit Union President/C.E.O. in the overall "management" of the Credit Union assets. Essential Functions 1. Assist the President with projects, new services, obtaining bids, and so forth. 2. Ensure that the President is kept fully informed on the conditions and operations of the Credit Union, and of all important factors influencing them. 3. Assist in the development, implementation and maintenance of operational procedures to maximize efficiency and quality of work, and to provide consistent quality service to members. 4. Assume all responsibilities of the Credit Union President/CEO in his/her absence. 5. Prepare or responsible for overseeing the preparation of monthly, quarterly and annual financial and statistical reports for the President and Board of Directors. 6. Prepare for review by President and approval by the Board of Directors the Budget for the Credit Union which is consistent with the overall strategic plan. To implement and oversee the Budget after approval. 7. Security Officer of the Credit Union. 8. Serve as Bank Secrecy Act Compliance Officer, NMLS (National Mortgage Licensing System), responsible for Truth in Savings and other Regulatory compliance. Annual Federal Reserve Report - Reg D - Form 2910a. NMLS (Nationwide Mortgage Licensing System) - Registration for new and renewal of staff and so forth. 9. Ensure that the Credit Union is in compliance with state and federal laws and regulations as established by the National Credit Union Administration (NCUA), the Nebraska Department of Banking and Finance, FFIEC, and other regulatory agencies. 10. Act on Credit Union investments as a member of the Investment Committee. Obtain together information from the various Board approved investment vendors and also direct investments to include the investment maturity ladder for decision making. 11. Assist President in preparing weekly staff meetings. 12. Assist the President with the replenishment and verifying cash for MSR and MSR/Clerk cash drawers. Replenish and verify safe totals with the President or PAR with Supervisory Authority. 13. Balance previous day's business cash to GL balance; Review daily reports - Large Member Checks clearing; Cash transaction register; Override; Undo and Dormant Account reports; Loan maintenance; Make daily cash flow projection; Post Hold files and so forth. 14. Balance Millennium Corporate statements on a weekly basis. 15. Prepare Employee Retirement Plan reporting for 401(k) and Defined Benefit. 16. Responsible for insurance paperwork to include: Maintaining records for life insurance, long term disability, health and dental. Make insurance disbursements and premium collections for health, life and long-term disability including wrap and summary of benefits for employees. 17. Responsible for the Credit Union's Bond and Casualty Insurance to include: questionnaires, reporting and bond claims. Completes CUNA Mutual Group bond renewal with President. 18. Take action on returned NSF checks deposited to member accounts. 19. Prepare quarterly reports for federal withholding, unemployment compensation, etc. 20. Prepare the quarterly Call Report for NCUA. 21. Prepare Annual 945 Report. 22. Attend Board of Director's monthly meetings and take minutes for the Board secretary. 23. Prepare and/or verify employee and vendor annual W-2's, 1099 MISC and so forth for year-end reporting. 24. Seek legal counsel in processing member POA, Trusts, Guardianship and Conservative accounts. In charge of deceased member accounts. Get appropriate documents, contact joint owners, seek legal counsel as needed and so forth. 25. File the unclaimed property report with the State by November 1 each year. 26. Create and maintain employee payroll records including their semi-monthly paystubs. 27. Staff Liaison for the IST Committee - prepares the agenda, research as needed and takes the Committee minutes. 28. Staff Liaison to the Supervisory Committee - prepares the agenda, research as needed and takes the Committee minutes. 29. Staff Liaison to the Delinquency Committee - prepares the agenda, research as needed and takes the Committee minutes. 30. Maintaining vendor contracts and due diligence to include recordkeeping, mailing notices in advance of potential non-renewal (typically six months), sending contracts to legal counsel for review and for opinion to submit to the Board of Directors, etc. 31. Participate in community and business affairs, as necessary, to contribute to the image of the Credit Union. 32. Other duties as assigned by the President. NOTE: The list of essential functions is not exhaustive. It may be supplemented as necessary from time to time. Vice President- Lincoln, NE #Hiring #Lincoln #Nebraska
09/25/2021
Full time
SPIRIT OF AMERICA FEDERAL CREDIT UNION General Summary: Responsible for Credit Union Accounting Records; Reporting to Government Agencies and Vendors; Liaison to Data Processor; Security; Regulatory Compliance. Credit Union experience (or financial institution) Required for Experience. Responsible for assisting the Credit Union President/C.E.O. in the overall "management" of the Credit Union assets. Essential Functions 1. Assist the President with projects, new services, obtaining bids, and so forth. 2. Ensure that the President is kept fully informed on the conditions and operations of the Credit Union, and of all important factors influencing them. 3. Assist in the development, implementation and maintenance of operational procedures to maximize efficiency and quality of work, and to provide consistent quality service to members. 4. Assume all responsibilities of the Credit Union President/CEO in his/her absence. 5. Prepare or responsible for overseeing the preparation of monthly, quarterly and annual financial and statistical reports for the President and Board of Directors. 6. Prepare for review by President and approval by the Board of Directors the Budget for the Credit Union which is consistent with the overall strategic plan. To implement and oversee the Budget after approval. 7. Security Officer of the Credit Union. 8. Serve as Bank Secrecy Act Compliance Officer, NMLS (National Mortgage Licensing System), responsible for Truth in Savings and other Regulatory compliance. Annual Federal Reserve Report - Reg D - Form 2910a. NMLS (Nationwide Mortgage Licensing System) - Registration for new and renewal of staff and so forth. 9. Ensure that the Credit Union is in compliance with state and federal laws and regulations as established by the National Credit Union Administration (NCUA), the Nebraska Department of Banking and Finance, FFIEC, and other regulatory agencies. 10. Act on Credit Union investments as a member of the Investment Committee. Obtain together information from the various Board approved investment vendors and also direct investments to include the investment maturity ladder for decision making. 11. Assist President in preparing weekly staff meetings. 12. Assist the President with the replenishment and verifying cash for MSR and MSR/Clerk cash drawers. Replenish and verify safe totals with the President or PAR with Supervisory Authority. 13. Balance previous day's business cash to GL balance; Review daily reports - Large Member Checks clearing; Cash transaction register; Override; Undo and Dormant Account reports; Loan maintenance; Make daily cash flow projection; Post Hold files and so forth. 14. Balance Millennium Corporate statements on a weekly basis. 15. Prepare Employee Retirement Plan reporting for 401(k) and Defined Benefit. 16. Responsible for insurance paperwork to include: Maintaining records for life insurance, long term disability, health and dental. Make insurance disbursements and premium collections for health, life and long-term disability including wrap and summary of benefits for employees. 17. Responsible for the Credit Union's Bond and Casualty Insurance to include: questionnaires, reporting and bond claims. Completes CUNA Mutual Group bond renewal with President. 18. Take action on returned NSF checks deposited to member accounts. 19. Prepare quarterly reports for federal withholding, unemployment compensation, etc. 20. Prepare the quarterly Call Report for NCUA. 21. Prepare Annual 945 Report. 22. Attend Board of Director's monthly meetings and take minutes for the Board secretary. 23. Prepare and/or verify employee and vendor annual W-2's, 1099 MISC and so forth for year-end reporting. 24. Seek legal counsel in processing member POA, Trusts, Guardianship and Conservative accounts. In charge of deceased member accounts. Get appropriate documents, contact joint owners, seek legal counsel as needed and so forth. 25. File the unclaimed property report with the State by November 1 each year. 26. Create and maintain employee payroll records including their semi-monthly paystubs. 27. Staff Liaison for the IST Committee - prepares the agenda, research as needed and takes the Committee minutes. 28. Staff Liaison to the Supervisory Committee - prepares the agenda, research as needed and takes the Committee minutes. 29. Staff Liaison to the Delinquency Committee - prepares the agenda, research as needed and takes the Committee minutes. 30. Maintaining vendor contracts and due diligence to include recordkeeping, mailing notices in advance of potential non-renewal (typically six months), sending contracts to legal counsel for review and for opinion to submit to the Board of Directors, etc. 31. Participate in community and business affairs, as necessary, to contribute to the image of the Credit Union. 32. Other duties as assigned by the President. NOTE: The list of essential functions is not exhaustive. It may be supplemented as necessary from time to time. Vice President- Lincoln, NE #Hiring #Lincoln #Nebraska
The Sr Director of Operations is responsible to the Regional Vice President for operational oversight and administration of dialysis services within a specified Market Service Area (MSA). *Senior Director Operations* *About Satellite Healthcare* Satellite Healthcare is more than simply a dialysis company. Since our founding in 1974, we have become the industry's leader in personalized quality care: 70% of our centers earn 4- and 5-star ratings from Medicaid and Medicare.gov, far ahead of all other providers. Our success in caring for patients can be attributed to our mission, our not-for-profit structure, and our people. Together, they create a powerfully patient-centered organization. Our mission is clear: to make life better for people living with kidney disease. Because we are a non-profit, we can pursue that mission with all our resources, united by our passion for patient care. As part of our commitment to continuous improvement, Satellite Research explores new ways to elevate the effectiveness and delivery of dialysis therapy. And Satellite Wellbound is leading the industry in home dialysis because better outcomes and quality of life are our highest priority. We are also substantial contributors to community and philanthropic kidney initiatives. Across our organization, we share a single mission - to make life better for those living with kidney disease. [Watch our video to learn more about our mission.]() *About the Role* The Sr Director of Operations is responsible to the Regional Vice President for operational oversight and administration of dialysis services within a specified Market Service Area (MSA). The Operations Senior Director is a member of the dialysis team and leads and supports both the strategic and quality plans for a specific MSA of operations. The Sr Director of Operations provides supervision, mentoring and coaching to Center Managers within the MSA in all areas of responsibilities especially in quality and operations. Quality services are defined and measured for all patients based on the direction and guidance of the Chief Medical Officer (CMO). The Senior Director of Operations works collaboratively with the Medical Director(s) and Center Manager of each center to resolve issues and improve the overall performance of center. The Senior Director of Operations provides guidance and support to the local Quality Assurance Performance Improvement (QAPI) program including the patient experience. The Senior Director of Operations maintains a strong working relationship with physicians, medical practices and payers within their business area. The Senior Director of Operations works collaboratively with Medical Affairs and Business Development staff and other corporate departments to define, implement and evaluate corporate initiatives, and responds to specific direction from the Executive Team. The person in this position, if assigned to oversee a center with a DADS license, may also be designated as the Alternate Administrator, Alternate Supervising Nurse, or Director of Nursing. Essential Functions : *Operations* Market Service Area and Dialysis Center Leadership * Provides supervision, mentoring and advice to the Center Managers * Provides leadership and direction in the opening of new centers * Encourages and develops leadership at all levels of the organization * Provides corporate visibility and shares corporate communication with centers * Facilitates center management and the technical team in problem solving facility and supply issues/concerns * Supports matrix management as it functions with ancillary services including administrative functions, social work, nutrition, and quality * In absence of the Regional Vice President, the Senior Director of Operations has the authority to carry out responsibilities of the Regional Vice President for the MSA Employee Management * Plans and promotes all levels of staff involvement in the operations * Develops a recruitment and retention plan for the region with HR * Provides direction and supervision of hiring and disciplinary action at the center level and consults Human Resources when necessary * Reviews focal reviews with Center Managers, working collaboratively in assessing performance and setting goals * Utilizes the pyramid as a teaching tool for Clinical Management on staff development and retention * Monitors staff education and training programs * Promotes teamwork by offering information, advice, and assistance to all staff members in a positive, courteous, and cooperative manner * Contributes to Satellite being employer of choice Financial Oversight * Prepares and monitors, in collaboration with the Finance Department and clinical management staff, the operating and capital budgets for each center * Ensures that established financial targets are met * Works with Finance to support vendor contracts * Monitors the use of company guidelines for staffing ratios/patient scheduling * Identifies opportunities for cost savings in labor and supplies Regulatory Oversight * Ensures that centers operate in compliance with all State and Federal regulations, especially the CMS Conditions for Coverage for End Stage Renal Disease Facilities (Code of Federal Regulations 42, Federal Register of April 15, 2008) and the DHS Interpretive Guidelines * Ensures that Texas centers with a license from the Department of Aging and Disability Services ("DADS"), operate in compliance with all State and Federal regulations, including the Texas Administrative Code ("TAC"), Title 40, Part 1, Chapter 97 * Ensures that centers are in compliance with the submission of accurate data and other information to governing agencies (e.g. ESRD Networks) in a timely manner * Participates in mock surveys and holds Center Manager accountable for performance plans * Attends Governing Board Review at least twice a year at each center *Quality Assurance/Improvement/Outcomes* Quality Assurance/Improvement * Ensures and directs the quality programs of each center, to assure that Satellite QA/QI targets are met and standards of patient care are practiced * Works directly with the Director of Quality to coach and monitor the Center Managers in quality and improvement * Ensures quarterly QAPI meetings are held at each center and attends as needed * Provides new ideas and products to the Regional Vice President, CMO and Quality leadership Patient Care * Supports and contributes to the standardization of Satellite Policies & Procedures (P&Ps) * Coaches the Center Manager in the delivery of safe and effective patient care * Ensures that documentation and medical records practices are followed according to Satellite policy Customer Service/Patient Experience * Ensures that Center Managers are coordinating and delivering efficient services * Support Patient Experience with surveys and action plans to improve experience * Work with all aspects of Patient Experience: * Physician /patient relationship * Patient involvement/knowledge * Perception of staff awareness and compassion * Monitors and evaluates employee and provider satisfaction * Directs customer service standards and practices * Builds strong teams to support quality of care * Embraces and encourages the patient experience through education and feedback * Ensure staff awareness and participation in patient experience * Works directly with Medical Director to address communication with all physicians: * Responds to concerns or issues immediately and appropriately * Supports and coaches Medical Director in utilizing an effective QAPI process * Communicates clearly, concisely, collaboratively, and non-defensively with colleagues, direct reports, corporate staff, corporate management and Center staff * Builds and maintains relationships with key customers (Kaiser, HMOs, PPOs, etc.) * Conducts routine meetings with payers to improve communication and service * Ensures compliance with oversight and regulatory needs of the provider *Business Area Relationships* Strategic Planning * Understands and drives organic growth within a geographic area * Communicates market share trends and growth opportunities to Business Development * Monitors occupancy of centers and makes recommendations on expansion or reduction in capacity * Establishes relationships with key stakeholders in region (hospitals, payers, physicians, case managers, discharge planners, etc.) * Investigates innovative practices to differentiate Satellite from competitors Physician/ Payer Relationships * Builds and nurtures Physician's relationship with Medical Director and all referring physicians * Looks for opportunities to align new physicians with Satellite * Responds to requests and ideas on a routine basis * Participates in physician meetings or conferences * Extends knowledge and support to resolve both patient and administrative issues * Works with payers to address their needs or concerns * Listens to new ideas or ways to improve Satellite services *Corporate Direction* Business Plan * Directs the strategic plan for the business region * Updates demographics of each center * Maintains a market awareness of providers, competitors, or other business opportunities * Works with business development to enhance market development * Develops and nurtures provider partnerships * Builds and support physician relationships Supports Quality Plan * Working with colleagues..... click apply for full job details
09/24/2021
The Sr Director of Operations is responsible to the Regional Vice President for operational oversight and administration of dialysis services within a specified Market Service Area (MSA). *Senior Director Operations* *About Satellite Healthcare* Satellite Healthcare is more than simply a dialysis company. Since our founding in 1974, we have become the industry's leader in personalized quality care: 70% of our centers earn 4- and 5-star ratings from Medicaid and Medicare.gov, far ahead of all other providers. Our success in caring for patients can be attributed to our mission, our not-for-profit structure, and our people. Together, they create a powerfully patient-centered organization. Our mission is clear: to make life better for people living with kidney disease. Because we are a non-profit, we can pursue that mission with all our resources, united by our passion for patient care. As part of our commitment to continuous improvement, Satellite Research explores new ways to elevate the effectiveness and delivery of dialysis therapy. And Satellite Wellbound is leading the industry in home dialysis because better outcomes and quality of life are our highest priority. We are also substantial contributors to community and philanthropic kidney initiatives. Across our organization, we share a single mission - to make life better for those living with kidney disease. [Watch our video to learn more about our mission.]() *About the Role* The Sr Director of Operations is responsible to the Regional Vice President for operational oversight and administration of dialysis services within a specified Market Service Area (MSA). The Operations Senior Director is a member of the dialysis team and leads and supports both the strategic and quality plans for a specific MSA of operations. The Sr Director of Operations provides supervision, mentoring and coaching to Center Managers within the MSA in all areas of responsibilities especially in quality and operations. Quality services are defined and measured for all patients based on the direction and guidance of the Chief Medical Officer (CMO). The Senior Director of Operations works collaboratively with the Medical Director(s) and Center Manager of each center to resolve issues and improve the overall performance of center. The Senior Director of Operations provides guidance and support to the local Quality Assurance Performance Improvement (QAPI) program including the patient experience. The Senior Director of Operations maintains a strong working relationship with physicians, medical practices and payers within their business area. The Senior Director of Operations works collaboratively with Medical Affairs and Business Development staff and other corporate departments to define, implement and evaluate corporate initiatives, and responds to specific direction from the Executive Team. The person in this position, if assigned to oversee a center with a DADS license, may also be designated as the Alternate Administrator, Alternate Supervising Nurse, or Director of Nursing. Essential Functions : *Operations* Market Service Area and Dialysis Center Leadership * Provides supervision, mentoring and advice to the Center Managers * Provides leadership and direction in the opening of new centers * Encourages and develops leadership at all levels of the organization * Provides corporate visibility and shares corporate communication with centers * Facilitates center management and the technical team in problem solving facility and supply issues/concerns * Supports matrix management as it functions with ancillary services including administrative functions, social work, nutrition, and quality * In absence of the Regional Vice President, the Senior Director of Operations has the authority to carry out responsibilities of the Regional Vice President for the MSA Employee Management * Plans and promotes all levels of staff involvement in the operations * Develops a recruitment and retention plan for the region with HR * Provides direction and supervision of hiring and disciplinary action at the center level and consults Human Resources when necessary * Reviews focal reviews with Center Managers, working collaboratively in assessing performance and setting goals * Utilizes the pyramid as a teaching tool for Clinical Management on staff development and retention * Monitors staff education and training programs * Promotes teamwork by offering information, advice, and assistance to all staff members in a positive, courteous, and cooperative manner * Contributes to Satellite being employer of choice Financial Oversight * Prepares and monitors, in collaboration with the Finance Department and clinical management staff, the operating and capital budgets for each center * Ensures that established financial targets are met * Works with Finance to support vendor contracts * Monitors the use of company guidelines for staffing ratios/patient scheduling * Identifies opportunities for cost savings in labor and supplies Regulatory Oversight * Ensures that centers operate in compliance with all State and Federal regulations, especially the CMS Conditions for Coverage for End Stage Renal Disease Facilities (Code of Federal Regulations 42, Federal Register of April 15, 2008) and the DHS Interpretive Guidelines * Ensures that Texas centers with a license from the Department of Aging and Disability Services ("DADS"), operate in compliance with all State and Federal regulations, including the Texas Administrative Code ("TAC"), Title 40, Part 1, Chapter 97 * Ensures that centers are in compliance with the submission of accurate data and other information to governing agencies (e.g. ESRD Networks) in a timely manner * Participates in mock surveys and holds Center Manager accountable for performance plans * Attends Governing Board Review at least twice a year at each center *Quality Assurance/Improvement/Outcomes* Quality Assurance/Improvement * Ensures and directs the quality programs of each center, to assure that Satellite QA/QI targets are met and standards of patient care are practiced * Works directly with the Director of Quality to coach and monitor the Center Managers in quality and improvement * Ensures quarterly QAPI meetings are held at each center and attends as needed * Provides new ideas and products to the Regional Vice President, CMO and Quality leadership Patient Care * Supports and contributes to the standardization of Satellite Policies & Procedures (P&Ps) * Coaches the Center Manager in the delivery of safe and effective patient care * Ensures that documentation and medical records practices are followed according to Satellite policy Customer Service/Patient Experience * Ensures that Center Managers are coordinating and delivering efficient services * Support Patient Experience with surveys and action plans to improve experience * Work with all aspects of Patient Experience: * Physician /patient relationship * Patient involvement/knowledge * Perception of staff awareness and compassion * Monitors and evaluates employee and provider satisfaction * Directs customer service standards and practices * Builds strong teams to support quality of care * Embraces and encourages the patient experience through education and feedback * Ensure staff awareness and participation in patient experience * Works directly with Medical Director to address communication with all physicians: * Responds to concerns or issues immediately and appropriately * Supports and coaches Medical Director in utilizing an effective QAPI process * Communicates clearly, concisely, collaboratively, and non-defensively with colleagues, direct reports, corporate staff, corporate management and Center staff * Builds and maintains relationships with key customers (Kaiser, HMOs, PPOs, etc.) * Conducts routine meetings with payers to improve communication and service * Ensures compliance with oversight and regulatory needs of the provider *Business Area Relationships* Strategic Planning * Understands and drives organic growth within a geographic area * Communicates market share trends and growth opportunities to Business Development * Monitors occupancy of centers and makes recommendations on expansion or reduction in capacity * Establishes relationships with key stakeholders in region (hospitals, payers, physicians, case managers, discharge planners, etc.) * Investigates innovative practices to differentiate Satellite from competitors Physician/ Payer Relationships * Builds and nurtures Physician's relationship with Medical Director and all referring physicians * Looks for opportunities to align new physicians with Satellite * Responds to requests and ideas on a routine basis * Participates in physician meetings or conferences * Extends knowledge and support to resolve both patient and administrative issues * Works with payers to address their needs or concerns * Listens to new ideas or ways to improve Satellite services *Corporate Direction* Business Plan * Directs the strategic plan for the business region * Updates demographics of each center * Maintains a market awareness of providers, competitors, or other business opportunities * Works with business development to enhance market development * Develops and nurtures provider partnerships * Builds and support physician relationships Supports Quality Plan * Working with colleagues..... click apply for full job details
Job Summary Amgen is seeking a Director Quality reporting directly to the Vice President, Final Product Quality and Surveillance. This team leads and manages the global Response to Questions (RTQ) process and ensures consistency in approach and deliverables globally. This may include facilitation, escalation and advice on critical issues. The team delivers ongoing monitoring of post market regulatory environment and identification of opportunities and improvements. The Director leads a global team of quality professionals, maintaining accountability for day to day operations of the team. Maintains a state of compliance across Final Product Quality in alignment with GxP (GMP, MDR, PMSR). Sets requirements and procedures to formalize global communication with Competent Authorities driven by Post- Market Surveillance programs. Ensures that there is an adequate number of qualified personnel who possess a combination of education, experience and training to perform the work in accordance with requirements and specifications. Key Responsibilities: Drives a global and consistent process for Responses to Questions (RTQ) as it relates to Final Product Brings together the necessary subject matter experts to ensure appropriate strategy for Responses to Questions (RTQ), Involved in the evaluation, impact assessment, and implementation of outcomes associated with Regulatory Trends and Risks Facilitate global support of Final Product Technology and Quality during internal audits and inspections relevant to Final Product & Surveillance (Complaints). Provides oversight of process for tracking, communicating and, managing CAPAs associated with internal and external audit/inspection commitments Drives insights generation through ongoing, active monitoring Identifies opportunities for improvement to regulatory communications and reporting (i.e., RTQ, BPDR, FAR, EuMDR) Leverages deep knowledge of Quality Management Systems to inform recommendations and improvement opportunities Facilitates inspection continuous improvement (e.g., summarizing lessons learned, takeaways from Management Review, etc.) to identify areas of greatest opportunity Ensures team's collaboration with Corporate Quality Compliance, Site Compliance, and Quality Leadership Teams to identify themes across the network Designs and provides oversight for management of the internal self-audit Final Product Quality program, leveraging the work of Corporate Quality Compliance Provides input into changes or improvements to the Quality Management System (QMS) Outlines infrastructure, strategy, and best practices for audit preparations to ensure consistency across Final Product Quality and Surveillance Participates in and coordinates inspectional preparation activities to prepare for domestic and foreign regulatory agency inspections Ensures a pool of subject matter experts are prepared to support audit and inspection activities Maintains responsibility as document custodian (e.g., playbooks etc.) Provides oversight to ensure compliance to SOPs, and teams are applying a consistent approach Identifies, interprets, and disseminates new regulatory trends, expectations and compliance documents Serves as an active member in the development of regulatory documents that provide guidance for the oversight of final product. Assesses the state of compliance with appropriate regulations and participates in the development of action plans to correct deficiencies Serves as Final Product Quality Compliance representative in group meetings and interacts with other departments in order to achieve goals Participates in the coordination, execution and closure of internal and for-cause audits and regulatory inspections for Final Product Evaluates and provides feedback to Final Product Quality team on potential compliance vulnerabilities Provides compliance-based recommendations and coordinates mitigation activities Oversees generation of compliance performance metrics and their presentation to key stakeholders and management as requested Provides compliance assessments as needed (examples: for validation philosophies, operational problem-solving exercises, SOP changes, technical reports etc.) Partners with Regulatory Affairs to draft and review regulatory submissions (INDs, BLAs, NDAs, other applications and supplements/amendments) Supports and identifies continual improvement initiatives, programs and projects Leads cross-functional initiatives Ensures execution of regulatory and SOP requirements Provides guidance and technical advice Basic Qualifications Doctorate degree and 4 years of Quality experience OR Masters degree and 8 years of Quality experience OR Bachelors degree and 10 years of Quality experience AND 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications 10+ years of quality and manufacturing experience in biotech or pharmaceutical industry Advanced Degree in a Science Field Knowledge of current Global regulations for final drug product, combination product, and devices and their application In depth understanding of Investigations and Root Cause Analysis Understands criticality of connectivity between product complaints and adverse events Significant experience hosting or participating in regulatory inspections Detail-oriented with experience in QA/QC functions across a broad range of manufacturing, QC and/or supply chain processes Ability to work in a team matrix environment and independently interact with various levels of management Excellent communication skills, both written and oral Ability to effectively present information to all levels of the organization with appropriate messaging and effective focus on desired outcomes Proven ability to create cross-functional networks/partnerships Ability to plan, monitor, and control a set of activities, ensuring efficient utilization of resources to achieve program objectives Leadership skills and the ability to oversee multiple projects simultaneously, including cross-functionally Able to successfully manage workload, timelines, and priorities Able to respond and provide astute advice quickly to difficult scenarios or in response to tough questions Ability to negotiate a strategic position after taking feedback from multiple sources Ability to operate in a matrixed or team environment with site, functional, and executive leadership Experience driving effective decision making Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device Manufacturing, Design Controls) Ability to succinctly communicate level of risk, urgency, or impact to the business Ability to travel +/- 20% of time to domestic and international Amgen sites Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
09/14/2021
Full time
Job Summary Amgen is seeking a Director Quality reporting directly to the Vice President, Final Product Quality and Surveillance. This team leads and manages the global Response to Questions (RTQ) process and ensures consistency in approach and deliverables globally. This may include facilitation, escalation and advice on critical issues. The team delivers ongoing monitoring of post market regulatory environment and identification of opportunities and improvements. The Director leads a global team of quality professionals, maintaining accountability for day to day operations of the team. Maintains a state of compliance across Final Product Quality in alignment with GxP (GMP, MDR, PMSR). Sets requirements and procedures to formalize global communication with Competent Authorities driven by Post- Market Surveillance programs. Ensures that there is an adequate number of qualified personnel who possess a combination of education, experience and training to perform the work in accordance with requirements and specifications. Key Responsibilities: Drives a global and consistent process for Responses to Questions (RTQ) as it relates to Final Product Brings together the necessary subject matter experts to ensure appropriate strategy for Responses to Questions (RTQ), Involved in the evaluation, impact assessment, and implementation of outcomes associated with Regulatory Trends and Risks Facilitate global support of Final Product Technology and Quality during internal audits and inspections relevant to Final Product & Surveillance (Complaints). Provides oversight of process for tracking, communicating and, managing CAPAs associated with internal and external audit/inspection commitments Drives insights generation through ongoing, active monitoring Identifies opportunities for improvement to regulatory communications and reporting (i.e., RTQ, BPDR, FAR, EuMDR) Leverages deep knowledge of Quality Management Systems to inform recommendations and improvement opportunities Facilitates inspection continuous improvement (e.g., summarizing lessons learned, takeaways from Management Review, etc.) to identify areas of greatest opportunity Ensures team's collaboration with Corporate Quality Compliance, Site Compliance, and Quality Leadership Teams to identify themes across the network Designs and provides oversight for management of the internal self-audit Final Product Quality program, leveraging the work of Corporate Quality Compliance Provides input into changes or improvements to the Quality Management System (QMS) Outlines infrastructure, strategy, and best practices for audit preparations to ensure consistency across Final Product Quality and Surveillance Participates in and coordinates inspectional preparation activities to prepare for domestic and foreign regulatory agency inspections Ensures a pool of subject matter experts are prepared to support audit and inspection activities Maintains responsibility as document custodian (e.g., playbooks etc.) Provides oversight to ensure compliance to SOPs, and teams are applying a consistent approach Identifies, interprets, and disseminates new regulatory trends, expectations and compliance documents Serves as an active member in the development of regulatory documents that provide guidance for the oversight of final product. Assesses the state of compliance with appropriate regulations and participates in the development of action plans to correct deficiencies Serves as Final Product Quality Compliance representative in group meetings and interacts with other departments in order to achieve goals Participates in the coordination, execution and closure of internal and for-cause audits and regulatory inspections for Final Product Evaluates and provides feedback to Final Product Quality team on potential compliance vulnerabilities Provides compliance-based recommendations and coordinates mitigation activities Oversees generation of compliance performance metrics and their presentation to key stakeholders and management as requested Provides compliance assessments as needed (examples: for validation philosophies, operational problem-solving exercises, SOP changes, technical reports etc.) Partners with Regulatory Affairs to draft and review regulatory submissions (INDs, BLAs, NDAs, other applications and supplements/amendments) Supports and identifies continual improvement initiatives, programs and projects Leads cross-functional initiatives Ensures execution of regulatory and SOP requirements Provides guidance and technical advice Basic Qualifications Doctorate degree and 4 years of Quality experience OR Masters degree and 8 years of Quality experience OR Bachelors degree and 10 years of Quality experience AND 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications 10+ years of quality and manufacturing experience in biotech or pharmaceutical industry Advanced Degree in a Science Field Knowledge of current Global regulations for final drug product, combination product, and devices and their application In depth understanding of Investigations and Root Cause Analysis Understands criticality of connectivity between product complaints and adverse events Significant experience hosting or participating in regulatory inspections Detail-oriented with experience in QA/QC functions across a broad range of manufacturing, QC and/or supply chain processes Ability to work in a team matrix environment and independently interact with various levels of management Excellent communication skills, both written and oral Ability to effectively present information to all levels of the organization with appropriate messaging and effective focus on desired outcomes Proven ability to create cross-functional networks/partnerships Ability to plan, monitor, and control a set of activities, ensuring efficient utilization of resources to achieve program objectives Leadership skills and the ability to oversee multiple projects simultaneously, including cross-functionally Able to successfully manage workload, timelines, and priorities Able to respond and provide astute advice quickly to difficult scenarios or in response to tough questions Ability to negotiate a strategic position after taking feedback from multiple sources Ability to operate in a matrixed or team environment with site, functional, and executive leadership Experience driving effective decision making Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device Manufacturing, Design Controls) Ability to succinctly communicate level of risk, urgency, or impact to the business Ability to travel +/- 20% of time to domestic and international Amgen sites Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek ---- so they can do what they do best: improve the world around us. Information about Agilent is available at . This is a terrific opportunity for a highly versatile individual to work in a fast-paced environment, providing executive administrative support to the Vice President of Global Quality & Regulatory Affairs (GQRA) for the Diagnostics and Genomics Group (DGG). The VP, GQRA for DGG leads the global quality and regulatory affairs organization for DGG and has oversight for ensuring consistent targeted quality of products by developing, refining and implementing quality programs and processes, while responsible for implementing regulatory strategies and programs that enable DGG to develop and market products and services that impactfully serve customers. The VP, GQRA, DGG serves as a key member of both the Global Quality and Regulatory Affairs and the DGG executive leadership teams and will work in close partnership with the other leaders to refine and execute the multi-year DGG strategy and enable the realization of DGG's mission to improve the human condition by bringing the power of precisions medicine to customers, partners and patients. The Executive Assistant to the VP, GQRA, DGG manages a broad range of advanced and diversified tasks and details, handles highly sensitive and confidential information on a regular basis, and requires a high level of discretion. The ideal candidate must have exceptional judgment, comprehensive experience, skill, and knowledge of company operations, policies, practices, and procedures. Requires deep proficiency in a broad range of administrative and operational activities. The ideal candidate will have experience assessing and anticipating Executive needs and be comfortable with making independent decisions. In addition, the candidate will apply their extensive experience and creative problem-solving skills to work on projects that are complex in nature and have narrow deadlines. Confident under pressure and happy with multi-tasking, the candidate will be in a unique position to provide high-level executive support and contribute to Agilent's growth and success. The role is located in Carpenteria, CA or Santa Clara, CA. The position may occasionally provide backup support to Executive Assistants of the VPs in GQRA. Responsibilities include: Proactively manages calendars and schedules, including coordinating meeting logistics globally, as well as recurring internal staff meetings and other Executive level reviews. Maintains awareness of significant deadlines and plans proactively for them. Coordinates all aspects of travel arrangements including booking flights, hotel and local transportation; providing itineraries; and arranging visa/passport requirements as needed. Prepares and reconciles travel expense reports. Manages calendar for internal and external events, possibly assisting with the consolidation and distribution of meeting material, planning and management of webcasts so VP is prepared for each engagement. Communicates professionally with internal customers, external suppliers and regulatory authorities, other executives and employees at all levels of the company. Manages creation and tracking of large purchase orders. Works with the internal procurement team to add new suppliers to the vendor database, then works with finance to track monthly expenses. Establishes and manages SharePoint database. Responsible for ensuring Org Charts, job descriptions and training profiles are maintained and updated on Internal Group site. Supports GQRA, DGG leaders and full team during meetings, events, correspondence, and communication activities. Responsible for providing On-Boarding support for new hires reporting to the VP. Understands and fully complies with SEC regulation Fair Disclosure which limits what can be shared about the company with internal and external individuals As needed, may participate in and/or lead projects within the function Knowledge, Skills, and Abilities: Excellent judgment and discretion, high integrity Strong verbal and written communication skills Current computer skills & user of MS 365 business applications such as Word, Excel, PowerPoint. Proficient in use of collaboration tools such as Spark, WebEx, Telepresence, Telepresence enabled WebEx Ability to work independently and as part of a team Proven time management and organization skills Excellent interpersonal skills. Positive demeanor, confident style, can-do attitude Ability to professionally engage with demanding and sometimes challenging stakeholders Good judgment and decision-making skills Requires the ability to direct questions and solve problems independently. Ability to prioritize and take initiative Ability to multi-task in a sometimes high-stress environment Significant attention to detail and follow-through skills Associate degree and/or higher education, specialized training, or certification desired. Prior experience providing administrative support at an executive level. Minimum of 5 years of relevant experiences is required, and 8 years of experience is desired. Quality Assurance or Regulatory Affairs experience would be a plus. Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to diversity in the workplace and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email or contact +1-. For more information about equal employment opportunity protections, please see all of our notices for EEO below.
08/30/2021
Full time
Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek ---- so they can do what they do best: improve the world around us. Information about Agilent is available at . This is a terrific opportunity for a highly versatile individual to work in a fast-paced environment, providing executive administrative support to the Vice President of Global Quality & Regulatory Affairs (GQRA) for the Diagnostics and Genomics Group (DGG). The VP, GQRA for DGG leads the global quality and regulatory affairs organization for DGG and has oversight for ensuring consistent targeted quality of products by developing, refining and implementing quality programs and processes, while responsible for implementing regulatory strategies and programs that enable DGG to develop and market products and services that impactfully serve customers. The VP, GQRA, DGG serves as a key member of both the Global Quality and Regulatory Affairs and the DGG executive leadership teams and will work in close partnership with the other leaders to refine and execute the multi-year DGG strategy and enable the realization of DGG's mission to improve the human condition by bringing the power of precisions medicine to customers, partners and patients. The Executive Assistant to the VP, GQRA, DGG manages a broad range of advanced and diversified tasks and details, handles highly sensitive and confidential information on a regular basis, and requires a high level of discretion. The ideal candidate must have exceptional judgment, comprehensive experience, skill, and knowledge of company operations, policies, practices, and procedures. Requires deep proficiency in a broad range of administrative and operational activities. The ideal candidate will have experience assessing and anticipating Executive needs and be comfortable with making independent decisions. In addition, the candidate will apply their extensive experience and creative problem-solving skills to work on projects that are complex in nature and have narrow deadlines. Confident under pressure and happy with multi-tasking, the candidate will be in a unique position to provide high-level executive support and contribute to Agilent's growth and success. The role is located in Carpenteria, CA or Santa Clara, CA. The position may occasionally provide backup support to Executive Assistants of the VPs in GQRA. Responsibilities include: Proactively manages calendars and schedules, including coordinating meeting logistics globally, as well as recurring internal staff meetings and other Executive level reviews. Maintains awareness of significant deadlines and plans proactively for them. Coordinates all aspects of travel arrangements including booking flights, hotel and local transportation; providing itineraries; and arranging visa/passport requirements as needed. Prepares and reconciles travel expense reports. Manages calendar for internal and external events, possibly assisting with the consolidation and distribution of meeting material, planning and management of webcasts so VP is prepared for each engagement. Communicates professionally with internal customers, external suppliers and regulatory authorities, other executives and employees at all levels of the company. Manages creation and tracking of large purchase orders. Works with the internal procurement team to add new suppliers to the vendor database, then works with finance to track monthly expenses. Establishes and manages SharePoint database. Responsible for ensuring Org Charts, job descriptions and training profiles are maintained and updated on Internal Group site. Supports GQRA, DGG leaders and full team during meetings, events, correspondence, and communication activities. Responsible for providing On-Boarding support for new hires reporting to the VP. Understands and fully complies with SEC regulation Fair Disclosure which limits what can be shared about the company with internal and external individuals As needed, may participate in and/or lead projects within the function Knowledge, Skills, and Abilities: Excellent judgment and discretion, high integrity Strong verbal and written communication skills Current computer skills & user of MS 365 business applications such as Word, Excel, PowerPoint. Proficient in use of collaboration tools such as Spark, WebEx, Telepresence, Telepresence enabled WebEx Ability to work independently and as part of a team Proven time management and organization skills Excellent interpersonal skills. Positive demeanor, confident style, can-do attitude Ability to professionally engage with demanding and sometimes challenging stakeholders Good judgment and decision-making skills Requires the ability to direct questions and solve problems independently. Ability to prioritize and take initiative Ability to multi-task in a sometimes high-stress environment Significant attention to detail and follow-through skills Associate degree and/or higher education, specialized training, or certification desired. Prior experience providing administrative support at an executive level. Minimum of 5 years of relevant experiences is required, and 8 years of experience is desired. Quality Assurance or Regulatory Affairs experience would be a plus. Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to diversity in the workplace and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email or contact +1-. For more information about equal employment opportunity protections, please see all of our notices for EEO below.
Maryland Independent College & University Association
Annapolis, Maryland
The Maryland Independent College and University Association (MICUA), a non-profit association which has as its mission the representation, coordination, and impassioned advocacy on behalf of independent higher education in Maryland, is seeking an experienced individual to assist in providing academic policy leadership as well as directing and facilitating the collection and analysis of research and other information. The successful candidate must have the ability to manage a diversity of internal and external constituencies, effective public-speaking skills, the capacity for hard work in an intense and challenging environment, and an understanding and appreciation of the nature of independent higher education and the issues important to academe. In addition to academic policy leadership and the direction and facilitation of research collection and analysis, the Vice President is responsible for: assisting with the capital grants process; assisting with state and federal government relations and lobbying activities; advocating for financial aid for independent students; representing MICUA on various state and national policy forums; and coordinating other projects and initiatives as assigned by the President. General Description: The Vice President for Academic Affairs reports to the President of MICUA and provides strong leadership and impassioned advocacy for higher education policy issues in support of the broader mission of the Association and independent higher education. S/he works closely with the President and the Associate Vice President for Government and Business Affairs (AVP), campus leaders, and State and federal officials on legislation, regulatory matters, communications, and other activities impacting member institutions. Responsibilities of the Vice President focus on managing issues related to academic affairs, assisting with the MICUA capital grants process, assisting with government relations and lobbying activities, directing and facilitating the collection and analysis of research and other information, coordinating financial aid policy, and executing other projects and initiatives as assigned by the President. Specific Duties and Responsibilities: *Academic Affairs* * Convene and coordinate periodic meetings of the MICUA chief academic officers and other campus-based affinity groups, as appropriate. * Provide support for member campuses with the states academic program approval processes, including the interpretation of state policies and regulations and proposal review when requested. * Pre-circulate academic program proposals among MICUA member institutions. * Coordinate MICUA members comments and objections to program proposals from non-MICUA member institutions; assist MICUA institutions in responding to objections from other institutions and pursuing appeals to the Commission, when necessary. * Coordinate academic initiatives in areas including undergraduate education, transfer and articulation, and teacher preparation; serve on statewide committees and workgroups in these areas including the Student Transfer Advisory Committee, Intersegmental Chief Academic Officers, MICUA-USM Deans and Directors, AAT Oversight Council, MADTECC, M.O.S.T. Advisory Committee, and ad hoc committees and workgroups. * Monitor policy development, regulations, and legislation related to academic issues at the State and federal levels, including accreditation and licensing bodies. Attend (or watch remotely) meetings of the Maryland Higher Education Commission, Maryland State Board of Education, and the Professional Standards Teacher Education Board. *MICUA Capital Grants (in cooperation with the AVP)* * Coordinate MICUAs annual state capital grants program for member institutions. * Monitor the states Capital Improvement Program to assess the impact on higher education, particularly the independent colleges and universities. * Prepare MICUAs annual Five-Year Capital Improvement Plan for endorsement by the Capital Projects Committee and approval by the MICUA Board. * Serve as a liaison between the MICUA member institutions and the staff of the Maryland Higher Education Commission, Department of Budget and Management, and Department of Legislative Services on all capital grant requests. * Update the MICUA Capital Projects Training Manual annually. * Coordinate the annual MICUA Capital Projects Committee meeting and MICUA Capital Projects training workshop. * Review and assist in the completion of institutional capital grant applications. * Upload all grant applications into the states Capital Budget Information System (CBIS). * Coordinate and oversee the MICUA capital grants process from initial application, executive and legislative review and authorization, through project completion. * Track capital match certifications with the Board of Public Works. *Government Relations (in cooperation with the AVP)* * Assist with analyzing federal and state legislation and regulations relating to academic issues that impact independent higher education; prepare testimony and position papers; work with elected officials, government officials, and their staff; and assist with testifying before legislative committees. * Help coordinate Congressional visits and assist with the preparation of briefing materials. * Track bills during the Maryland Legislative Session on topics related to academic issues. *Research Collection and Analysis (in cooperation with the Research Analyst)* * Coordinate the collection of data and information from the Maryland Higher Education Commission, the National Center for Education Statistics (NCES), the National Postsecondary Student Aid Survey (NPSAS), the Integrated Postsecondary Education Data System (IPEDS), and other state and federal sources. * Conduct surveys and compile and analyze responses from the MICUA institutions. * Evaluate and integrate studies and reports that impact higher education. A graduate degree in a related discipline or juris doctor is required. At least 5 years of experience effectively navigating the Maryland Higher Education Commission (MHEC), advocating before Congress and/or the Maryland General Assembly, and managing academic policies that are important to the independent higher education sector is preferred. A candidate is expected to exhibit a proven history of competence in management; progressive experience with academic policy development; positive social relationships and interactions with colleagues, supervisors, and other stakeholders; a willingness to challenge and attempt to exceed expectations; and strong written and oral communication skills. The position is salaried between $100,000 and $150,000 and offers a full range of benefits, including health, dental, vision, long-term disability, and life insurance. MICUA does not discriminate on the basis of sex, race, color, national origin, sexual orientation, gender identity or gender expression, marital status, pregnancy, disability, religion, or age in recruitment, admission and access to, or employment with the organization. Please email a resume and a letter of interest that includes three professional references to: Ashley Swift, Manager of Business Operations, at [](mailto:). Candidates may also submit letter(s) of recommendation for consideration. The position remains open until filled; however, letters of interest must be received by January 18, 2021, to guarantee full consideration.
01/30/2021
Full time
The Maryland Independent College and University Association (MICUA), a non-profit association which has as its mission the representation, coordination, and impassioned advocacy on behalf of independent higher education in Maryland, is seeking an experienced individual to assist in providing academic policy leadership as well as directing and facilitating the collection and analysis of research and other information. The successful candidate must have the ability to manage a diversity of internal and external constituencies, effective public-speaking skills, the capacity for hard work in an intense and challenging environment, and an understanding and appreciation of the nature of independent higher education and the issues important to academe. In addition to academic policy leadership and the direction and facilitation of research collection and analysis, the Vice President is responsible for: assisting with the capital grants process; assisting with state and federal government relations and lobbying activities; advocating for financial aid for independent students; representing MICUA on various state and national policy forums; and coordinating other projects and initiatives as assigned by the President. General Description: The Vice President for Academic Affairs reports to the President of MICUA and provides strong leadership and impassioned advocacy for higher education policy issues in support of the broader mission of the Association and independent higher education. S/he works closely with the President and the Associate Vice President for Government and Business Affairs (AVP), campus leaders, and State and federal officials on legislation, regulatory matters, communications, and other activities impacting member institutions. Responsibilities of the Vice President focus on managing issues related to academic affairs, assisting with the MICUA capital grants process, assisting with government relations and lobbying activities, directing and facilitating the collection and analysis of research and other information, coordinating financial aid policy, and executing other projects and initiatives as assigned by the President. Specific Duties and Responsibilities: *Academic Affairs* * Convene and coordinate periodic meetings of the MICUA chief academic officers and other campus-based affinity groups, as appropriate. * Provide support for member campuses with the states academic program approval processes, including the interpretation of state policies and regulations and proposal review when requested. * Pre-circulate academic program proposals among MICUA member institutions. * Coordinate MICUA members comments and objections to program proposals from non-MICUA member institutions; assist MICUA institutions in responding to objections from other institutions and pursuing appeals to the Commission, when necessary. * Coordinate academic initiatives in areas including undergraduate education, transfer and articulation, and teacher preparation; serve on statewide committees and workgroups in these areas including the Student Transfer Advisory Committee, Intersegmental Chief Academic Officers, MICUA-USM Deans and Directors, AAT Oversight Council, MADTECC, M.O.S.T. Advisory Committee, and ad hoc committees and workgroups. * Monitor policy development, regulations, and legislation related to academic issues at the State and federal levels, including accreditation and licensing bodies. Attend (or watch remotely) meetings of the Maryland Higher Education Commission, Maryland State Board of Education, and the Professional Standards Teacher Education Board. *MICUA Capital Grants (in cooperation with the AVP)* * Coordinate MICUAs annual state capital grants program for member institutions. * Monitor the states Capital Improvement Program to assess the impact on higher education, particularly the independent colleges and universities. * Prepare MICUAs annual Five-Year Capital Improvement Plan for endorsement by the Capital Projects Committee and approval by the MICUA Board. * Serve as a liaison between the MICUA member institutions and the staff of the Maryland Higher Education Commission, Department of Budget and Management, and Department of Legislative Services on all capital grant requests. * Update the MICUA Capital Projects Training Manual annually. * Coordinate the annual MICUA Capital Projects Committee meeting and MICUA Capital Projects training workshop. * Review and assist in the completion of institutional capital grant applications. * Upload all grant applications into the states Capital Budget Information System (CBIS). * Coordinate and oversee the MICUA capital grants process from initial application, executive and legislative review and authorization, through project completion. * Track capital match certifications with the Board of Public Works. *Government Relations (in cooperation with the AVP)* * Assist with analyzing federal and state legislation and regulations relating to academic issues that impact independent higher education; prepare testimony and position papers; work with elected officials, government officials, and their staff; and assist with testifying before legislative committees. * Help coordinate Congressional visits and assist with the preparation of briefing materials. * Track bills during the Maryland Legislative Session on topics related to academic issues. *Research Collection and Analysis (in cooperation with the Research Analyst)* * Coordinate the collection of data and information from the Maryland Higher Education Commission, the National Center for Education Statistics (NCES), the National Postsecondary Student Aid Survey (NPSAS), the Integrated Postsecondary Education Data System (IPEDS), and other state and federal sources. * Conduct surveys and compile and analyze responses from the MICUA institutions. * Evaluate and integrate studies and reports that impact higher education. A graduate degree in a related discipline or juris doctor is required. At least 5 years of experience effectively navigating the Maryland Higher Education Commission (MHEC), advocating before Congress and/or the Maryland General Assembly, and managing academic policies that are important to the independent higher education sector is preferred. A candidate is expected to exhibit a proven history of competence in management; progressive experience with academic policy development; positive social relationships and interactions with colleagues, supervisors, and other stakeholders; a willingness to challenge and attempt to exceed expectations; and strong written and oral communication skills. The position is salaried between $100,000 and $150,000 and offers a full range of benefits, including health, dental, vision, long-term disability, and life insurance. MICUA does not discriminate on the basis of sex, race, color, national origin, sexual orientation, gender identity or gender expression, marital status, pregnancy, disability, religion, or age in recruitment, admission and access to, or employment with the organization. Please email a resume and a letter of interest that includes three professional references to: Ashley Swift, Manager of Business Operations, at [](mailto:). Candidates may also submit letter(s) of recommendation for consideration. The position remains open until filled; however, letters of interest must be received by January 18, 2021, to guarantee full consideration.
Maryland Independent College & University Association
Annapolis, Maryland
The Maryland Independent College and University Association (MICUA), a non-profit association which has as its mission the representation, coordination, and impassioned advocacy on behalf of independent higher education in Maryland, is seeking an experienced individual to assist in providing academic policy leadership as well as directing and facilitating the collection and analysis of research and other information. The successful candidate must have the ability to manage a diversity of internal and external constituencies, effective public-speaking skills, the capacity for hard work in an intense and challenging environment, and an understanding and appreciation of the nature of independent higher education and the issues important to academe. In addition to academic policy leadership and the direction and facilitation of research collection and analysis, the Vice President is responsible for: assisting with the capital grants process; assisting with state and federal government relations and lobbying activities; advocating for financial aid for independent students; representing MICUA on various state and national policy forums; and coordinating other projects and initiatives as assigned by the President. General Description: The Vice President for Academic Affairs reports to the President of MICUA and provides strong leadership and impassioned advocacy for higher education policy issues in support of the broader mission of the Association and independent higher education. S/he works closely with the President and the Associate Vice President for Government and Business Affairs (AVP), campus leaders, and State and federal officials on legislation, regulatory matters, communications, and other activities impacting member institutions. Responsibilities of the Vice President focus on managing issues related to academic affairs, assisting with the MICUA capital grants process, assisting with government relations and lobbying activities, directing and facilitating the collection and analysis of research and other information, coordinating financial aid policy, and executing other projects and initiatives as assigned by the President. Specific Duties and Responsibilities: Academic Affairs Convene and coordinate periodic meetings of the MICUA chief academic officers and other campus-based affinity groups, as appropriate. Provide support for member campuses with the state's academic program approval processes, including the interpretation of state policies and regulations and proposal review when requested. Pre-circulate academic program proposals among MICUA member institutions. Coordinate MICUA members' comments and objections to program proposals from non-MICUA member institutions; assist MICUA institutions in responding to objections from other institutions and pursuing appeals to the Commission, when necessary. Coordinate academic initiatives in areas including undergraduate education, transfer and articulation, and teacher preparation; serve on statewide committees and workgroups in these areas including the Student Transfer Advisory Committee, Intersegmental Chief Academic Officers, MICUA-USM Deans and Directors, AAT Oversight Council, MADTECC, M.O.S.T. Advisory Committee, and ad hoc committees and workgroups. Monitor policy development, regulations, and legislation related to academic issues at the State and federal levels, including accreditation and licensing bodies. Attend (or watch remotely) meetings of the Maryland Higher Education Commission, Maryland State Board of Education, and the Professional Standards Teacher Education Board. MICUA Capital Grants (in cooperation with the AVP) Coordinate MICUA's annual state capital grants program for member institutions. Monitor the state's Capital Improvement Program to assess the impact on higher education, particularly the independent colleges and universities. Prepare MICUA's annual Five-Year Capital Improvement Plan for endorsement by the Capital Projects Committee and approval by the MICUA Board. Serve as a liaison between the MICUA member institutions and the staff of the Maryland Higher Education Commission, Department of Budget and Management, and Department of Legislative Services on all capital grant requests. Update the MICUA Capital Projects Training Manual annually. Coordinate the annual MICUA Capital Projects Committee meeting and MICUA Capital Projects training workshop. Review and assist in the completion of institutional capital grant applications. Upload all grant applications into the state's Capital Budget Information System (CBIS). Coordinate and oversee the MICUA capital grants process from initial application, executive and legislative review and authorization, through project completion. Track capital match certifications with the Board of Public Works. Government Relations (in cooperation with the AVP) Assist with analyzing federal and state legislation and regulations relating to academic issues that impact independent higher education; prepare testimony and position papers; work with elected officials, government officials, and their staff; and assist with testifying before legislative committees. Help coordinate Congressional visits and assist with the preparation of briefing materials. Track bills during the Maryland Legislative Session on topics related to academic issues. Research Collection and Analysis (in cooperation with the Research Analyst) Coordinate the collection of data and information from the Maryland Higher Education Commission, the National Center for Education Statistics (NCES), the National Postsecondary Student Aid Survey (NPSAS), the Integrated Postsecondary Education Data System (IPEDS), and other state and federal sources. Conduct surveys and compile and analyze responses from the MICUA institutions. Evaluate and integrate studies and reports that impact higher education. A graduate degree in a related discipline or juris doctor is required. At least 5 years of experience effectively navigating the Maryland Higher Education Commission (MHEC), advocating before Congress and/or the Maryland General Assembly, and managing academic policies that are important to the independent higher education sector is preferred. A candidate is expected to exhibit a proven history of competence in management; progressive experience with academic policy development; positive social relationships and interactions with colleagues, supervisors, and other stakeholders; a willingness to challenge and attempt to exceed expectations; and strong written and oral communication skills. The position is salaried between $100,000 and $150,000 and offers a full range of benefits, including health, dental, vision, long-term disability, and life insurance. MICUA does not discriminate on the basis of sex, race, color, national origin, sexual orientation, gender identity or gender expression, marital status, pregnancy, disability, religion, or age in recruitment, admission and access to, or employment with the organization. Please email a resume and a letter of interest that includes three professional references to: Ashley Swift, Manager of Business Operations, at . Candidates may also submit letter(s) of recommendation for consideration. The position remains open until filled; however, letters of interest must be received by January 18, 2021, to guarantee full consideration.
01/28/2021
Full time
The Maryland Independent College and University Association (MICUA), a non-profit association which has as its mission the representation, coordination, and impassioned advocacy on behalf of independent higher education in Maryland, is seeking an experienced individual to assist in providing academic policy leadership as well as directing and facilitating the collection and analysis of research and other information. The successful candidate must have the ability to manage a diversity of internal and external constituencies, effective public-speaking skills, the capacity for hard work in an intense and challenging environment, and an understanding and appreciation of the nature of independent higher education and the issues important to academe. In addition to academic policy leadership and the direction and facilitation of research collection and analysis, the Vice President is responsible for: assisting with the capital grants process; assisting with state and federal government relations and lobbying activities; advocating for financial aid for independent students; representing MICUA on various state and national policy forums; and coordinating other projects and initiatives as assigned by the President. General Description: The Vice President for Academic Affairs reports to the President of MICUA and provides strong leadership and impassioned advocacy for higher education policy issues in support of the broader mission of the Association and independent higher education. S/he works closely with the President and the Associate Vice President for Government and Business Affairs (AVP), campus leaders, and State and federal officials on legislation, regulatory matters, communications, and other activities impacting member institutions. Responsibilities of the Vice President focus on managing issues related to academic affairs, assisting with the MICUA capital grants process, assisting with government relations and lobbying activities, directing and facilitating the collection and analysis of research and other information, coordinating financial aid policy, and executing other projects and initiatives as assigned by the President. Specific Duties and Responsibilities: Academic Affairs Convene and coordinate periodic meetings of the MICUA chief academic officers and other campus-based affinity groups, as appropriate. Provide support for member campuses with the state's academic program approval processes, including the interpretation of state policies and regulations and proposal review when requested. Pre-circulate academic program proposals among MICUA member institutions. Coordinate MICUA members' comments and objections to program proposals from non-MICUA member institutions; assist MICUA institutions in responding to objections from other institutions and pursuing appeals to the Commission, when necessary. Coordinate academic initiatives in areas including undergraduate education, transfer and articulation, and teacher preparation; serve on statewide committees and workgroups in these areas including the Student Transfer Advisory Committee, Intersegmental Chief Academic Officers, MICUA-USM Deans and Directors, AAT Oversight Council, MADTECC, M.O.S.T. Advisory Committee, and ad hoc committees and workgroups. Monitor policy development, regulations, and legislation related to academic issues at the State and federal levels, including accreditation and licensing bodies. Attend (or watch remotely) meetings of the Maryland Higher Education Commission, Maryland State Board of Education, and the Professional Standards Teacher Education Board. MICUA Capital Grants (in cooperation with the AVP) Coordinate MICUA's annual state capital grants program for member institutions. Monitor the state's Capital Improvement Program to assess the impact on higher education, particularly the independent colleges and universities. Prepare MICUA's annual Five-Year Capital Improvement Plan for endorsement by the Capital Projects Committee and approval by the MICUA Board. Serve as a liaison between the MICUA member institutions and the staff of the Maryland Higher Education Commission, Department of Budget and Management, and Department of Legislative Services on all capital grant requests. Update the MICUA Capital Projects Training Manual annually. Coordinate the annual MICUA Capital Projects Committee meeting and MICUA Capital Projects training workshop. Review and assist in the completion of institutional capital grant applications. Upload all grant applications into the state's Capital Budget Information System (CBIS). Coordinate and oversee the MICUA capital grants process from initial application, executive and legislative review and authorization, through project completion. Track capital match certifications with the Board of Public Works. Government Relations (in cooperation with the AVP) Assist with analyzing federal and state legislation and regulations relating to academic issues that impact independent higher education; prepare testimony and position papers; work with elected officials, government officials, and their staff; and assist with testifying before legislative committees. Help coordinate Congressional visits and assist with the preparation of briefing materials. Track bills during the Maryland Legislative Session on topics related to academic issues. Research Collection and Analysis (in cooperation with the Research Analyst) Coordinate the collection of data and information from the Maryland Higher Education Commission, the National Center for Education Statistics (NCES), the National Postsecondary Student Aid Survey (NPSAS), the Integrated Postsecondary Education Data System (IPEDS), and other state and federal sources. Conduct surveys and compile and analyze responses from the MICUA institutions. Evaluate and integrate studies and reports that impact higher education. A graduate degree in a related discipline or juris doctor is required. At least 5 years of experience effectively navigating the Maryland Higher Education Commission (MHEC), advocating before Congress and/or the Maryland General Assembly, and managing academic policies that are important to the independent higher education sector is preferred. A candidate is expected to exhibit a proven history of competence in management; progressive experience with academic policy development; positive social relationships and interactions with colleagues, supervisors, and other stakeholders; a willingness to challenge and attempt to exceed expectations; and strong written and oral communication skills. The position is salaried between $100,000 and $150,000 and offers a full range of benefits, including health, dental, vision, long-term disability, and life insurance. MICUA does not discriminate on the basis of sex, race, color, national origin, sexual orientation, gender identity or gender expression, marital status, pregnancy, disability, religion, or age in recruitment, admission and access to, or employment with the organization. Please email a resume and a letter of interest that includes three professional references to: Ashley Swift, Manager of Business Operations, at . Candidates may also submit letter(s) of recommendation for consideration. The position remains open until filled; however, letters of interest must be received by January 18, 2021, to guarantee full consideration.
About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on Twitter , Facebook , Instagram , YouTube and LinkedIn . Job SUMMARY: Allergan is looking for an experienced business leader with a demonstrated track record of developing high-performing teams, collaborating and influencing across matrixed organizations! The ideal candidate will have an exceptional ability to deeply understand the science and landscape, as well as the business considerations important to developing and implementing customer centric strategies. This role will require a leader who combines executive presence, emotional intelligence and a strong work ethic to develop a best-in-class strategic planning capability within the body contouring franchise. The Executive Director, reports to the Associate Vice President of Marketing, and is responsible for the development, analysis and refinement of the body contouring downstream strategies. The Executive Director, Body Contouring Professional Marketing is responsible for the HCP strategy development and commercialization of one of the most exciting launches in the body contouring industry. Responsibilities include, capital and consumable strategies to drive rapid adoption within the body contouring marketplace, pricing and value proposition strategy and consumer activation strategies to drive growth. A key imperative is to maximize the uptake at launch and ultimate value of the brand. This position works in close collaboration with cross functional groups to ensure a successful launch and growth in the core CoolSculpting business. Including sales, Allergan Data Labs, professional relations, finance, sales training, supply operations and GCD. This position works closely with the body contouring HCP community and will need to build strong relationships and gain product advocacy with KOLs, customers and prospects. Therefore, this individual should be highly collaborative, as they will be working with various internal customers and external partners, as well as getting buy-in from key stakeholders. The ideal candidate will have a solid track-record demonstrating strong business acumen, where s/he has successfully taken ideas from inception to completion. Supervisory responsibility: (if applicable) Lead and manage a team that is accountable for the professional strategies to drive system adoption and consumable growth for the Body Contouring division. KEY DUTIES AND RESPONSIBILITIES: Describe scope: % of Time or Importance Responsible for leading a comprehensive commercialization plan, developing HCP product positioning, core messages, growth strategy and annual marketing plan. Analyze competitive promotional activity and implement appropriate actions. Reviews and responds to changing market dynamics, as indicated through market analysis, customer interaction and sales input, to ensure achievement of goals by directing activities to a rapidly evolving landscape. Provide ongoing program leadership, supervise vendors and agencies and support field execution. Monitor and accelerate program performance through sales and ROI analysis. Contribute towards achieving brand financial and market share goals, manage promotional budget, deliver quarterly profit targets 40% Drive CoolSculpting commercial programs through a collaborative approach with sales and consumer marketing team (ADL) to develop and execute highly effective commercial impact with customers. These programs should incorporate KOL / advisory board feedback from customers. Responsible for overseeing management of all professional program related education, managing the commercial programs budget and external vendors to ensure efficient use of funds, ROI against set objectives and optimal customer service to our customers. 25% Oversee the development and management of promotional programs and tools: Lead the team to develop promotional tactics and sales tools that support brand strategies for capital equipment and consumable businesses. Collaborate with Regulatory, Medical, Legal, Compliance in development of all promotional pieces and programs. Effectively and collaboratively manage agency partners. Participate as appropriate in meetings with Global Commercial Development, Med Affairs, and International Brand teams. 20% Develops and maintains a customer focus that includes effective working relationships with KOL customers (HCP's and CS Specialists) in conjunction with strategy and campaign development. Provide sales team leadership and training, work with field sales representatives on a regular basis, support field training as needed, attend major conventions and meetings, educational and prospecting programs and events. 15% Qualifications job QUALIFICATIONS (MINIMUM REQUIREMENTS): Requirements: Minimum 15+ years of professional industry experience, including at least 3+ years in managerial positions at a medium-to-large health care company (device, phamra, OTC or FMCG). 5+ years professional/consumer marketing- Medical Device preferred but not mandatory. Knowledge of health care and/or Medical Device industry preferred (not mandatory). Solid knowledge of marketing areas including product positioning, marketing plan development and execution, strategic communications, product launch etc. Successful track record of strategic and tactical marketing. Experience launching Medical Devices preferred. Essential Skills, and Competencies: Proven leadership ability to work effectively and influences through others Financial/budgetary experience Ability to analyze difficult, complex situations, understand the details, and not get lost in them Ability to make difficult decisions, deal quickly and effectively with changes, and confront conflict constructively (strong resolution skills) Excellent communication skills, both oral and written, with an ability to make effective presentations to customers, sales team, and senior management Ability to appropriately prioritize and execute multiple critical issues Strong interpersonal skills, managing multiple stakeholders in a changing and flexible environment Willingness to travel 40% of the time Significant Work Activities N/A Travel Yes, 5 % of the Time Job Type Experienced Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
01/28/2021
Full time
About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on Twitter , Facebook , Instagram , YouTube and LinkedIn . Job SUMMARY: Allergan is looking for an experienced business leader with a demonstrated track record of developing high-performing teams, collaborating and influencing across matrixed organizations! The ideal candidate will have an exceptional ability to deeply understand the science and landscape, as well as the business considerations important to developing and implementing customer centric strategies. This role will require a leader who combines executive presence, emotional intelligence and a strong work ethic to develop a best-in-class strategic planning capability within the body contouring franchise. The Executive Director, reports to the Associate Vice President of Marketing, and is responsible for the development, analysis and refinement of the body contouring downstream strategies. The Executive Director, Body Contouring Professional Marketing is responsible for the HCP strategy development and commercialization of one of the most exciting launches in the body contouring industry. Responsibilities include, capital and consumable strategies to drive rapid adoption within the body contouring marketplace, pricing and value proposition strategy and consumer activation strategies to drive growth. A key imperative is to maximize the uptake at launch and ultimate value of the brand. This position works in close collaboration with cross functional groups to ensure a successful launch and growth in the core CoolSculpting business. Including sales, Allergan Data Labs, professional relations, finance, sales training, supply operations and GCD. This position works closely with the body contouring HCP community and will need to build strong relationships and gain product advocacy with KOLs, customers and prospects. Therefore, this individual should be highly collaborative, as they will be working with various internal customers and external partners, as well as getting buy-in from key stakeholders. The ideal candidate will have a solid track-record demonstrating strong business acumen, where s/he has successfully taken ideas from inception to completion. Supervisory responsibility: (if applicable) Lead and manage a team that is accountable for the professional strategies to drive system adoption and consumable growth for the Body Contouring division. KEY DUTIES AND RESPONSIBILITIES: Describe scope: % of Time or Importance Responsible for leading a comprehensive commercialization plan, developing HCP product positioning, core messages, growth strategy and annual marketing plan. Analyze competitive promotional activity and implement appropriate actions. Reviews and responds to changing market dynamics, as indicated through market analysis, customer interaction and sales input, to ensure achievement of goals by directing activities to a rapidly evolving landscape. Provide ongoing program leadership, supervise vendors and agencies and support field execution. Monitor and accelerate program performance through sales and ROI analysis. Contribute towards achieving brand financial and market share goals, manage promotional budget, deliver quarterly profit targets 40% Drive CoolSculpting commercial programs through a collaborative approach with sales and consumer marketing team (ADL) to develop and execute highly effective commercial impact with customers. These programs should incorporate KOL / advisory board feedback from customers. Responsible for overseeing management of all professional program related education, managing the commercial programs budget and external vendors to ensure efficient use of funds, ROI against set objectives and optimal customer service to our customers. 25% Oversee the development and management of promotional programs and tools: Lead the team to develop promotional tactics and sales tools that support brand strategies for capital equipment and consumable businesses. Collaborate with Regulatory, Medical, Legal, Compliance in development of all promotional pieces and programs. Effectively and collaboratively manage agency partners. Participate as appropriate in meetings with Global Commercial Development, Med Affairs, and International Brand teams. 20% Develops and maintains a customer focus that includes effective working relationships with KOL customers (HCP's and CS Specialists) in conjunction with strategy and campaign development. Provide sales team leadership and training, work with field sales representatives on a regular basis, support field training as needed, attend major conventions and meetings, educational and prospecting programs and events. 15% Qualifications job QUALIFICATIONS (MINIMUM REQUIREMENTS): Requirements: Minimum 15+ years of professional industry experience, including at least 3+ years in managerial positions at a medium-to-large health care company (device, phamra, OTC or FMCG). 5+ years professional/consumer marketing- Medical Device preferred but not mandatory. Knowledge of health care and/or Medical Device industry preferred (not mandatory). Solid knowledge of marketing areas including product positioning, marketing plan development and execution, strategic communications, product launch etc. Successful track record of strategic and tactical marketing. Experience launching Medical Devices preferred. Essential Skills, and Competencies: Proven leadership ability to work effectively and influences through others Financial/budgetary experience Ability to analyze difficult, complex situations, understand the details, and not get lost in them Ability to make difficult decisions, deal quickly and effectively with changes, and confront conflict constructively (strong resolution skills) Excellent communication skills, both oral and written, with an ability to make effective presentations to customers, sales team, and senior management Ability to appropriately prioritize and execute multiple critical issues Strong interpersonal skills, managing multiple stakeholders in a changing and flexible environment Willingness to travel 40% of the time Significant Work Activities N/A Travel Yes, 5 % of the Time Job Type Experienced Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
Major purpose of this job: The Vice President (VP), Government Relations is responsible for organizational strategy for government relations. Responsibilities include establishing COMPANY 's goals and strategies relevant to government sectors and management of advocacy, communications, and related functions. The VP oversees and leads interdepartmental efforts associated with government policy and government agency initiatives. As a member of the Executive Team, the VP has oversight for advocacy for COMPANY 's strategic goals and business interests. The VP advises on issues and opportunities related to government contracts and, in collaboration with the General Counsel, assures compliance under government contracting rules and regulations. The Vice President serves as COMPANY 's strategic advisor on government relations and public policy to the CEO, Board of Directors, COMPANY leadership and acts as primary liaison to government agencies and other policy stakeholders. The VP oversees policy and strategy development for federal and state government as well as the oversight of consultants at the state level and supervises the activities of the Manager, Health Policy and Government Programs. The VP works directly with government agencies at the federal and state level and is COMPANY 's key representative for activities of the NAIC and other relevant federal and state associations and organizations. Job duties and responsibilities: Advocacy and Policy Development: Responsible for organizational strategy for government relations to include establishing COMPANY 's goals and strategies relevant to government sectors and management of advocacy, influence, communications, and related functions for the organization. Manage interdepartmental teams to assess operational and financial impact on COMPANY of legislation, regulation, sub-regulatory guidance, and other state and federal legislative and government actions. Direct COMPANY 's influence on, and response to, legislation, regulation, sub-regulatory guidance, and other government actions that impact COMPANY 's business or create business opportunities for COMPANY. Oversee ongoing environmental scanning, research and monitoring of government activities or RFPs in support of COMPANY 's programs and business development objectives. Initiate external communications messaging through content development of correspondence, presentations and other written or broadcast materials. Act as a thought-leader and content provider to both internal and external audiences. Execute educational activities that enhance internal staff understanding and knowledge of relevant public policy issues. Manage corporate and departmental policies and procedures related to COMPANY government and stakeholder relations. Provide supervision and direction to the Manager, Health Policy and Government Programs. Stakeholder Management: Establish and maintain relationships with federal and state officials, legislators, and regulators to assure COMPANY 's influence and value ( 'seat at the table '). Establish and maintain relationships with government and related external stakeholder groups such as think-tanks, trade associations, and professional societies to further COMPANY 's business goals and recognition as an influential thought leader and subject matter experts. Direct industry outreach efforts to providers, employers, trade associations, and other stakeholder groups who can support COMPANY 's state and federal strategies. Guide and direct interdepartmental teams to provide actionable, relevant market research and intelligence to achieve policy objectives. Develop strategies that enhance COMPANY 's profile as a thought leader and improve COMPANY program adoption in the market, working with and through other COMPANY staff and departments when advantageous. Guide and direct activities of board committees regarding government affairs and public policy. Guide and direct the activities of COMPANY 's Board Committee on Legislative and Regulatory Affairs. Manage, maintain and enhance a database of state and federal government relations contacts using appropriate systems/tools. Strategy Formulation: Design and pursue strategies for advancing COMPANY 's business goals through state and federal government as well as legislative bodies. Realize sales lead generation opportunities across all COMPANY program suites. Manage state level consultants as well as interdepartmental teams to successfully gain federal and state government awareness and recognition of COMPANY accreditation and avoid threats to COMPANY programs. Formulate and implement government related strategies to increase awareness of COMPANY and enhance COMPANY 's product attractiveness, primarily via recognition or mandate of COMPANY accreditation/certification in federal and/or states contracting and regulation. Advise COMPANY leadership on strategies related to government initiatives, including recognition or mandate, as a business driver and for the development or revision of accreditation/certification programs. Recognize COMPANY business opportunities and lead cross-functional teams to submit proposals to federal and state government for contracts and/or grants consistent with COMPANY strategic goals. Manage interdepartmental projects involving federal government representatives and government programs, including overseeing project criteria, collateral, timelines, staff participation and strategy formulation. Budget: Develop departmental budget and manage government relations activities consistent with budgeted expenses. Perform other related duties as assigned. Experience, knowledge, and skill requirements: Ten years of government relations and/or policy experience or relevant experience and education comparable to perform job duties. Successful track record of influencing senior-level executives, high-ranking public officials and key stakeholders. Substantial knowledge of the federal and state legislative and regulatory processes. Knowledge regarding federal Medicare and Medicaid policy, reimbursement models, and regulatory process. Knowledge regarding the role accreditation plays in different healthcare sectors including managed care, employers, and provider organizations preferred. Ability to communicate clearly and concisely, both orally and in writing. Ability to lead cross-functional teams to achieve a stated goal. Strong written and verbal communication skills as well as excellent research and analytical skills are required. Ability to effectively organize, manage and facilitate meetings and develop and maintain work plans. Technical proficiency in the use of Microsoft Office, (i.e., WORD, Excel, PowerPoint) is required. Some travel may be required (i.e., up to 30%). Ability to effectively communicate with technical and non-technical project team members. Education and training requirements: Bachelor 's degree required; graduate/law degree preferred.
01/27/2021
Full time
Major purpose of this job: The Vice President (VP), Government Relations is responsible for organizational strategy for government relations. Responsibilities include establishing COMPANY 's goals and strategies relevant to government sectors and management of advocacy, communications, and related functions. The VP oversees and leads interdepartmental efforts associated with government policy and government agency initiatives. As a member of the Executive Team, the VP has oversight for advocacy for COMPANY 's strategic goals and business interests. The VP advises on issues and opportunities related to government contracts and, in collaboration with the General Counsel, assures compliance under government contracting rules and regulations. The Vice President serves as COMPANY 's strategic advisor on government relations and public policy to the CEO, Board of Directors, COMPANY leadership and acts as primary liaison to government agencies and other policy stakeholders. The VP oversees policy and strategy development for federal and state government as well as the oversight of consultants at the state level and supervises the activities of the Manager, Health Policy and Government Programs. The VP works directly with government agencies at the federal and state level and is COMPANY 's key representative for activities of the NAIC and other relevant federal and state associations and organizations. Job duties and responsibilities: Advocacy and Policy Development: Responsible for organizational strategy for government relations to include establishing COMPANY 's goals and strategies relevant to government sectors and management of advocacy, influence, communications, and related functions for the organization. Manage interdepartmental teams to assess operational and financial impact on COMPANY of legislation, regulation, sub-regulatory guidance, and other state and federal legislative and government actions. Direct COMPANY 's influence on, and response to, legislation, regulation, sub-regulatory guidance, and other government actions that impact COMPANY 's business or create business opportunities for COMPANY. Oversee ongoing environmental scanning, research and monitoring of government activities or RFPs in support of COMPANY 's programs and business development objectives. Initiate external communications messaging through content development of correspondence, presentations and other written or broadcast materials. Act as a thought-leader and content provider to both internal and external audiences. Execute educational activities that enhance internal staff understanding and knowledge of relevant public policy issues. Manage corporate and departmental policies and procedures related to COMPANY government and stakeholder relations. Provide supervision and direction to the Manager, Health Policy and Government Programs. Stakeholder Management: Establish and maintain relationships with federal and state officials, legislators, and regulators to assure COMPANY 's influence and value ( 'seat at the table '). Establish and maintain relationships with government and related external stakeholder groups such as think-tanks, trade associations, and professional societies to further COMPANY 's business goals and recognition as an influential thought leader and subject matter experts. Direct industry outreach efforts to providers, employers, trade associations, and other stakeholder groups who can support COMPANY 's state and federal strategies. Guide and direct interdepartmental teams to provide actionable, relevant market research and intelligence to achieve policy objectives. Develop strategies that enhance COMPANY 's profile as a thought leader and improve COMPANY program adoption in the market, working with and through other COMPANY staff and departments when advantageous. Guide and direct activities of board committees regarding government affairs and public policy. Guide and direct the activities of COMPANY 's Board Committee on Legislative and Regulatory Affairs. Manage, maintain and enhance a database of state and federal government relations contacts using appropriate systems/tools. Strategy Formulation: Design and pursue strategies for advancing COMPANY 's business goals through state and federal government as well as legislative bodies. Realize sales lead generation opportunities across all COMPANY program suites. Manage state level consultants as well as interdepartmental teams to successfully gain federal and state government awareness and recognition of COMPANY accreditation and avoid threats to COMPANY programs. Formulate and implement government related strategies to increase awareness of COMPANY and enhance COMPANY 's product attractiveness, primarily via recognition or mandate of COMPANY accreditation/certification in federal and/or states contracting and regulation. Advise COMPANY leadership on strategies related to government initiatives, including recognition or mandate, as a business driver and for the development or revision of accreditation/certification programs. Recognize COMPANY business opportunities and lead cross-functional teams to submit proposals to federal and state government for contracts and/or grants consistent with COMPANY strategic goals. Manage interdepartmental projects involving federal government representatives and government programs, including overseeing project criteria, collateral, timelines, staff participation and strategy formulation. Budget: Develop departmental budget and manage government relations activities consistent with budgeted expenses. Perform other related duties as assigned. Experience, knowledge, and skill requirements: Ten years of government relations and/or policy experience or relevant experience and education comparable to perform job duties. Successful track record of influencing senior-level executives, high-ranking public officials and key stakeholders. Substantial knowledge of the federal and state legislative and regulatory processes. Knowledge regarding federal Medicare and Medicaid policy, reimbursement models, and regulatory process. Knowledge regarding the role accreditation plays in different healthcare sectors including managed care, employers, and provider organizations preferred. Ability to communicate clearly and concisely, both orally and in writing. Ability to lead cross-functional teams to achieve a stated goal. Strong written and verbal communication skills as well as excellent research and analytical skills are required. Ability to effectively organize, manage and facilitate meetings and develop and maintain work plans. Technical proficiency in the use of Microsoft Office, (i.e., WORD, Excel, PowerPoint) is required. Some travel may be required (i.e., up to 30%). Ability to effectively communicate with technical and non-technical project team members. Education and training requirements: Bachelor 's degree required; graduate/law degree preferred.
Fate Therapeutics is seeking an experienced and highly motivated regulatory professional to support its expanding cellular therapy programs. The Senior Manager / Manager, Regulatory Affairs (RA) will provide support to the Vice President, RA in the development and implementation of regulatory strategies for development products. This role is responsible for executing global Chemistry, Manufacturing and Control (CMC) regulatory strategies and content plans. The primary responsibility is to lead the CMC regulatory activities related to cellular therapies in clinical development. This role will support CMC Teams and provide direction on the interpretation and application of global CMC regulations and guidance related to cell therapies. This is a full-time position located at our corporate headquarters in San Diego, CA. Responsibilities • Serve as a RA CMC representative on project teams and provide regulatory expertise and input on cross-functional team recommendations to facilitate successful product development globally. • Support CMC teams to develop global submission plans that comply with local regulatory requirements and commitments. • Author and/or lead the preparation of regulatory dossiers for submission to global Health Authorities throughout the product lifecycle. • Effectively and thoughtfully communicate with Health Authorities while maintaining good rapport and credibility. When appropriate lead meetings with Health Authorities under supervision of a senior member of the RA Department. Develop and reach consensus on regulatory CMC strategy for Health Authority information request responses, as needed. • Provide accurate regulatory assessments of CMC changes to project teams and refine regulatory strategies as needed based on emerging data, therapeutic area, and evolving regulatory landscape. • Drive a corporate culture of continuous improvement to ensure compliance with Health Authority laws and recommendations, as well as industry best practices. • Develop and update contingency plans for issues that may affect product registration, regulatory compliance, and the continued lifecycle management of development products. • Escalate issues to Regulatory Management that may affect registration, regulatory compliance and continued lifecycle management of the product. • May lead selected initiatives within the Regulatory Department and/or provide oversight of assigned staff. Requirements • A minimum of a Bachelor of Science in biological, pharmaceutical, chemical, or engineering sciences with generally a minimum of 3+ years of experience in the pharmaceutical or health care industry is required. An MS, PhD, or PharmD. degree preferred. • Experience in biologics is preferred. • Strong knowledge of global Health Authority laws, regulations, guidance and regulation submission routes available for assigned products is required. • Strong experience directly writing submission documents that support clinical trials, marketing, and lifecycle management is required. • Experience in regulations or product development in gene therapy (i.e., CAR-Ts, AAVs, CRISPR technology etc.) is preferred. • Experience developing regulatory strategies and an understanding of product development, seen as an expert on product development and how it is applied in global regulatory strategy is required. • Strong attention to detail with high-level verbal and written communication skills is required; effectively communicates cross-functionally. Ability to present and defend regulatory strategies and opinions to project teams. • Strong ability to quickly absorb new technical and strategic information and have the flexibility to adapt accordingly. • High attention to detail, ability to work on multiple projects with tight deadlines, and able to work independently. • Demonstrates clear understanding of priorities and leads others by example to drive for results. • Good understanding of competitors in the area and what they are doing in early/late development is preferred. Working Conditions and Physical Requirements • May require occasional evening and weekend work • Full-time onsite work at Company's headquarters in San Diego • May require occasional travel for training programs and meetings The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time. For consideration send cover letter and resume to: and reference job 379JB. About Fate Therapeutics, Inc. Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for cancer and immune disorders. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Company's immuno-oncology product candidates include natural killer (NK) cell and T-cell cancer immunotherapies, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens with chimeric antigen receptors (CARs). The Company's immuno-regulatory product candidates include ProTmune™, a pharmacologically modulated, donor cell graft that is currently being evaluated in a Phase 2 clinical trial for the prevention of graft-versus-host disease, and a myeloid- derived suppressor cell immunotherapy for promoting immune tolerance in patients with immune disorders. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit .
01/25/2021
Full time
Fate Therapeutics is seeking an experienced and highly motivated regulatory professional to support its expanding cellular therapy programs. The Senior Manager / Manager, Regulatory Affairs (RA) will provide support to the Vice President, RA in the development and implementation of regulatory strategies for development products. This role is responsible for executing global Chemistry, Manufacturing and Control (CMC) regulatory strategies and content plans. The primary responsibility is to lead the CMC regulatory activities related to cellular therapies in clinical development. This role will support CMC Teams and provide direction on the interpretation and application of global CMC regulations and guidance related to cell therapies. This is a full-time position located at our corporate headquarters in San Diego, CA. Responsibilities • Serve as a RA CMC representative on project teams and provide regulatory expertise and input on cross-functional team recommendations to facilitate successful product development globally. • Support CMC teams to develop global submission plans that comply with local regulatory requirements and commitments. • Author and/or lead the preparation of regulatory dossiers for submission to global Health Authorities throughout the product lifecycle. • Effectively and thoughtfully communicate with Health Authorities while maintaining good rapport and credibility. When appropriate lead meetings with Health Authorities under supervision of a senior member of the RA Department. Develop and reach consensus on regulatory CMC strategy for Health Authority information request responses, as needed. • Provide accurate regulatory assessments of CMC changes to project teams and refine regulatory strategies as needed based on emerging data, therapeutic area, and evolving regulatory landscape. • Drive a corporate culture of continuous improvement to ensure compliance with Health Authority laws and recommendations, as well as industry best practices. • Develop and update contingency plans for issues that may affect product registration, regulatory compliance, and the continued lifecycle management of development products. • Escalate issues to Regulatory Management that may affect registration, regulatory compliance and continued lifecycle management of the product. • May lead selected initiatives within the Regulatory Department and/or provide oversight of assigned staff. Requirements • A minimum of a Bachelor of Science in biological, pharmaceutical, chemical, or engineering sciences with generally a minimum of 3+ years of experience in the pharmaceutical or health care industry is required. An MS, PhD, or PharmD. degree preferred. • Experience in biologics is preferred. • Strong knowledge of global Health Authority laws, regulations, guidance and regulation submission routes available for assigned products is required. • Strong experience directly writing submission documents that support clinical trials, marketing, and lifecycle management is required. • Experience in regulations or product development in gene therapy (i.e., CAR-Ts, AAVs, CRISPR technology etc.) is preferred. • Experience developing regulatory strategies and an understanding of product development, seen as an expert on product development and how it is applied in global regulatory strategy is required. • Strong attention to detail with high-level verbal and written communication skills is required; effectively communicates cross-functionally. Ability to present and defend regulatory strategies and opinions to project teams. • Strong ability to quickly absorb new technical and strategic information and have the flexibility to adapt accordingly. • High attention to detail, ability to work on multiple projects with tight deadlines, and able to work independently. • Demonstrates clear understanding of priorities and leads others by example to drive for results. • Good understanding of competitors in the area and what they are doing in early/late development is preferred. Working Conditions and Physical Requirements • May require occasional evening and weekend work • Full-time onsite work at Company's headquarters in San Diego • May require occasional travel for training programs and meetings The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time. For consideration send cover letter and resume to: and reference job 379JB. About Fate Therapeutics, Inc. Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for cancer and immune disorders. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Company's immuno-oncology product candidates include natural killer (NK) cell and T-cell cancer immunotherapies, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens with chimeric antigen receptors (CARs). The Company's immuno-regulatory product candidates include ProTmune™, a pharmacologically modulated, donor cell graft that is currently being evaluated in a Phase 2 clinical trial for the prevention of graft-versus-host disease, and a myeloid- derived suppressor cell immunotherapy for promoting immune tolerance in patients with immune disorders. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit .
HOW MIGHT YOU DEFY IMAGINATION? At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared mission-to serve patients-has driven our status as one of the world's preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses. Vice President, Global Value & Access (GV&A) Live What you will do Let's do this. Let's change the world. In this vital role the Vice President, Global Value & Access, is an important leadership role that will have a significant impact on the company. The Vice President is responsible for providing leadership and influencing key decisions to insure access of all Amgen products for all markets in the world. This will require an unusual mix of commercial experience, strategic skills, operating capabilities and market knowledge. Key Responsibilities: Lead all aspects of the Global Value and Access organization Global market access strategy deliverables: Integrated value and access insights and strategy for pipeline up to peri-launch Pricing, contracting, and negotiation guidance Pricing and Access assumptions for long range plan Prioritized strategic options for development to enable access & use Global Health Economics: Economic and value evidence generation Embedding Patient-centered outcomes into the development plan Global value dossiers, real world evidence, field and customer tools and resources Pricing and Access Center of Excellence: Early and Core models, local adaptations Early engagement, landscapes, methods, insights, writing, submissions, and negotiations Pricing and contracting operations, governance, and analytics Value Strategy and Communications Predict and Prevent efforts to help enable healthcare transformation and enhancement of Amgen's reputation Additional responsibilities: Leverage all available resources (e.g., clinical, regulatory, medical, marketing) to develop and implement strategic plans and identify and overcome access barriers Understand key health policy issues and inform Amgen policy positions to shape the health policy landscape Represent Amgen at key regional industry meetings and actively shape industry strategy Member of the GMAC (Global Marketing, Access, Capabilities) management team Collaborate and achieve synergies with functional heads from discovery, clinical development, regulatory, marketing, operations, medical affairs and other global functions to ensure robust value, access and policy perspective for all Amgen products Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. In the GV&A Vice President role, we seek a leader with these qualifications. Basic Qualifications: Doctorate degree & 8 years of directly related experience OR Master's degree & 10 years of directly related experience OR Bachelor's degree & 12 years of directly related experience AND 8 years of direct managerial experience. Previous experience managing other managers Preferred Qualifications: Understanding of global payer and government environment, including health economics, reimbursement, pricing and contracting, value drivers, HTA policy and health Policy Experience with all value & access aspects of product commercialization for early as well as late lifecycle products Experience with real world evidence generation that drives commercial priorities Leadership skills with demonstrated ability to lead cross-functional teams and country VA&P teams and engage in productive debate and collaboration with senior leaders Executive communication, oral and written presentation skills, including interpersonal skills to foster collaboration and succeed in a highly matrixed environment Strategic planning skills-both at the product and country (cross-portfolio) levels Ability to conduct situation analysis of external environment and synthesize relevant information for regional strategies and support development of country-specific strategic plans Ability to identify compelling ways to demonstrate and communicate product value to payers In market experience, either US or x-US US value and access leadership experience Direct payer experience and/or experience in product commercialization Strategic planning and health policy experience strongly preferred Understanding of strategic pricing and contracting, including innovative approaches such as risk-sharing deals Ability to review clinical and health economic literature, including disease state information, clinical trial design, endpoints, and comparators, and pharmacoeconomic studies in order to understand implications for payers Appreciation for and commitment to all aspects of diversity Experience in delivering on political access for pharmaceuticals in the region Understanding of government policy, commercial and business issues in the region gained from years of relevant experience Thrive What you can expect of us As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being. Clear and disciplined strategic vision for the future that leverages superior-quality products, operational excellence and top-shelf-talent Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do. We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
01/23/2021
Full time
HOW MIGHT YOU DEFY IMAGINATION? At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared mission-to serve patients-has driven our status as one of the world's preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses. Vice President, Global Value & Access (GV&A) Live What you will do Let's do this. Let's change the world. In this vital role the Vice President, Global Value & Access, is an important leadership role that will have a significant impact on the company. The Vice President is responsible for providing leadership and influencing key decisions to insure access of all Amgen products for all markets in the world. This will require an unusual mix of commercial experience, strategic skills, operating capabilities and market knowledge. Key Responsibilities: Lead all aspects of the Global Value and Access organization Global market access strategy deliverables: Integrated value and access insights and strategy for pipeline up to peri-launch Pricing, contracting, and negotiation guidance Pricing and Access assumptions for long range plan Prioritized strategic options for development to enable access & use Global Health Economics: Economic and value evidence generation Embedding Patient-centered outcomes into the development plan Global value dossiers, real world evidence, field and customer tools and resources Pricing and Access Center of Excellence: Early and Core models, local adaptations Early engagement, landscapes, methods, insights, writing, submissions, and negotiations Pricing and contracting operations, governance, and analytics Value Strategy and Communications Predict and Prevent efforts to help enable healthcare transformation and enhancement of Amgen's reputation Additional responsibilities: Leverage all available resources (e.g., clinical, regulatory, medical, marketing) to develop and implement strategic plans and identify and overcome access barriers Understand key health policy issues and inform Amgen policy positions to shape the health policy landscape Represent Amgen at key regional industry meetings and actively shape industry strategy Member of the GMAC (Global Marketing, Access, Capabilities) management team Collaborate and achieve synergies with functional heads from discovery, clinical development, regulatory, marketing, operations, medical affairs and other global functions to ensure robust value, access and policy perspective for all Amgen products Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. In the GV&A Vice President role, we seek a leader with these qualifications. Basic Qualifications: Doctorate degree & 8 years of directly related experience OR Master's degree & 10 years of directly related experience OR Bachelor's degree & 12 years of directly related experience AND 8 years of direct managerial experience. Previous experience managing other managers Preferred Qualifications: Understanding of global payer and government environment, including health economics, reimbursement, pricing and contracting, value drivers, HTA policy and health Policy Experience with all value & access aspects of product commercialization for early as well as late lifecycle products Experience with real world evidence generation that drives commercial priorities Leadership skills with demonstrated ability to lead cross-functional teams and country VA&P teams and engage in productive debate and collaboration with senior leaders Executive communication, oral and written presentation skills, including interpersonal skills to foster collaboration and succeed in a highly matrixed environment Strategic planning skills-both at the product and country (cross-portfolio) levels Ability to conduct situation analysis of external environment and synthesize relevant information for regional strategies and support development of country-specific strategic plans Ability to identify compelling ways to demonstrate and communicate product value to payers In market experience, either US or x-US US value and access leadership experience Direct payer experience and/or experience in product commercialization Strategic planning and health policy experience strongly preferred Understanding of strategic pricing and contracting, including innovative approaches such as risk-sharing deals Ability to review clinical and health economic literature, including disease state information, clinical trial design, endpoints, and comparators, and pharmacoeconomic studies in order to understand implications for payers Appreciation for and commitment to all aspects of diversity Experience in delivering on political access for pharmaceuticals in the region Understanding of government policy, commercial and business issues in the region gained from years of relevant experience Thrive What you can expect of us As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being. Clear and disciplined strategic vision for the future that leverages superior-quality products, operational excellence and top-shelf-talent Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do. We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on Twitter , Facebook , Instagram , YouTube and LinkedIn . Purpose: Partner with Oncology Development VP to drive and implement the vision of Therapeutic Area. Identify needs and provide recommendations to TA VP in supporting the achievement of corporate goals while responding effectively to changing priorities. Represent TA specific interests and collaborate cross-functionally. Responsibilities: Reports to Therapeutic Area Vice President in Development. Serves as Chief of Staff for the TA VP by independently representing TA VPs views. Communicates clearly, concisely, and in timely fashion items that require the VP's attention. Provides TA VP strategic and operational options for the department, including contingency planning. Provides rapid response to ad hoc requests from Public Affairs, Business Development, Legal, and other functions (e.g., analyses of competitive pipeline, response letters to Trade Commission re acquisitions, etc.). Responsible for developing resource maps including LRP and Plan to dynamically track workload and resource capacity. Partners with TA VP, Finance, BHR, Talent Acquisition, and other functions to ensure that TA Development expertise, capabilities, budget, and resources are available and leveraged appropriately through the portfolio. Leads TA initiatives that result in operational efficiencies, enhanced culture, or improved decision-making. Oversees the collection, synthesis and communication of relevant external information that informs the TA strategy across all functions. Supports strategic projects including LRP and coordinates Development input into TA Strategy document. Works with TA Staff to enhance teamwork and department culture, identify issues and partners with TA Leadership to identify workable solutions. Supports World-class R&D initiative by forging strategic partnerships with industry and top-tier academic institutions. Leads development of concept framework, initiates discussions with target institutions, and guides Transaction team during negotiations. Upon contract execution, drives all key components of external collaborations to ensure adherence to timelines and budgets. Supports TA related M&A, licensing, partnership assessments and due diligence activities, and determines needed communications to the appropriate team members as opportunities progress through the process. Develops briefing documents ahead of major scientific conferences to aid executive management in discussions with investment analysts and media. Coordinates and develops executive presentations inclusive of latest clinical data for investment analyst briefings, earnings calls, Board of Directors, Ministries of Health, road shows, etc. Qualifications Qualifications: Basic Qualifications: Bachelor's degree, at least ten years industry experience in Biotechnology, Pharmaceutical, or other Healthcare related field, experience with cross-functional teams and initiatives. Preferred Qualifications: Advanced degree, at least fifteen years of experience in pharmaceutical R&D, especially in a clinical development function, experience leading cross-functional teams and initiatives, certification in Project Management and/or Lean Six Sigma. Experience & Knowledge: Proven ability to lead, manage, and motivate others in a complex, multi-functional matrix environment Broad understanding of the pharmaceutical business, project management/project planning experience on global projects. Professional collaboration and leadership skills, excellent interpersonal and organizational skills, ability to effectively present ideas and document complex medical/clinical concepts and processes in both written and oral communication. History of anticipating and resolving problems while exhibiting superior judgment and a balanced, realistic understanding of issues Knowledge to represent and evaluate strategies for clinical development. Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and international regulatory requirements/guidelines. Understanding of how to conceptualize, design, and conduct complex, global clinical trials. Understanding of new drug commercialization and business practices. Key Stakeholders: VP of Development and VPs of Therapeutic Areas, HR, Finance. Significant Work Activities Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Travel No Job Type Experienced Schedule Full-time Job Level Code D Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
01/18/2021
Full time
About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on Twitter , Facebook , Instagram , YouTube and LinkedIn . Purpose: Partner with Oncology Development VP to drive and implement the vision of Therapeutic Area. Identify needs and provide recommendations to TA VP in supporting the achievement of corporate goals while responding effectively to changing priorities. Represent TA specific interests and collaborate cross-functionally. Responsibilities: Reports to Therapeutic Area Vice President in Development. Serves as Chief of Staff for the TA VP by independently representing TA VPs views. Communicates clearly, concisely, and in timely fashion items that require the VP's attention. Provides TA VP strategic and operational options for the department, including contingency planning. Provides rapid response to ad hoc requests from Public Affairs, Business Development, Legal, and other functions (e.g., analyses of competitive pipeline, response letters to Trade Commission re acquisitions, etc.). Responsible for developing resource maps including LRP and Plan to dynamically track workload and resource capacity. Partners with TA VP, Finance, BHR, Talent Acquisition, and other functions to ensure that TA Development expertise, capabilities, budget, and resources are available and leveraged appropriately through the portfolio. Leads TA initiatives that result in operational efficiencies, enhanced culture, or improved decision-making. Oversees the collection, synthesis and communication of relevant external information that informs the TA strategy across all functions. Supports strategic projects including LRP and coordinates Development input into TA Strategy document. Works with TA Staff to enhance teamwork and department culture, identify issues and partners with TA Leadership to identify workable solutions. Supports World-class R&D initiative by forging strategic partnerships with industry and top-tier academic institutions. Leads development of concept framework, initiates discussions with target institutions, and guides Transaction team during negotiations. Upon contract execution, drives all key components of external collaborations to ensure adherence to timelines and budgets. Supports TA related M&A, licensing, partnership assessments and due diligence activities, and determines needed communications to the appropriate team members as opportunities progress through the process. Develops briefing documents ahead of major scientific conferences to aid executive management in discussions with investment analysts and media. Coordinates and develops executive presentations inclusive of latest clinical data for investment analyst briefings, earnings calls, Board of Directors, Ministries of Health, road shows, etc. Qualifications Qualifications: Basic Qualifications: Bachelor's degree, at least ten years industry experience in Biotechnology, Pharmaceutical, or other Healthcare related field, experience with cross-functional teams and initiatives. Preferred Qualifications: Advanced degree, at least fifteen years of experience in pharmaceutical R&D, especially in a clinical development function, experience leading cross-functional teams and initiatives, certification in Project Management and/or Lean Six Sigma. Experience & Knowledge: Proven ability to lead, manage, and motivate others in a complex, multi-functional matrix environment Broad understanding of the pharmaceutical business, project management/project planning experience on global projects. Professional collaboration and leadership skills, excellent interpersonal and organizational skills, ability to effectively present ideas and document complex medical/clinical concepts and processes in both written and oral communication. History of anticipating and resolving problems while exhibiting superior judgment and a balanced, realistic understanding of issues Knowledge to represent and evaluate strategies for clinical development. Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and international regulatory requirements/guidelines. Understanding of how to conceptualize, design, and conduct complex, global clinical trials. Understanding of new drug commercialization and business practices. Key Stakeholders: VP of Development and VPs of Therapeutic Areas, HR, Finance. Significant Work Activities Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Travel No Job Type Experienced Schedule Full-time Job Level Code D Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
The Vice President of Regulatory Affairs is responsible for providing regulatory leadership and for the planning and oversight of all regulatory submissions from pre-submission to approval of product(s)/application(s). Responsible for addressing data requirements to regulatory authorities. This position will provide the regulatory and technical expertise into the Company's development plans of its product candidates. Prepares for and expedites early and effective approval of pharmaceutical new products in accordance with regulatory strategy. They will work cross-functionally with R&D, Quality, supply chain, compliance, legal, operations, marketing and other departments. Essential Job Functions: Represents the regulatory interest of the Company by meeting with regulatory agencies Provides expert regulatory advice internally to Senior Management and Board of directors when needed to ensure compliance with FDA regulations. Effectively communicates and implements determined regulatory strategy with the appropriate departments and/or employees. Works to minimize regulatory issues and helps prevent unnecessary regulatory delays Will train staff in the preparation of documentation for regulatory review in technical areas, and performs regular evaluation Ensure compliance of Company SOPs, protocols, and specifications in order to codify procedures to be used as a reference among Company employees and contractors Perform record review to assure quality submission of regulatory documents. This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Other duties, responsibilities and activities may change or be assigned at any time with or without notice. Education/ Qualifications: BA/BS Required, MBA is a plus or equivalent experience 12+ years of regulatory experience in the pharmaceutical / biotechnology industry Must have direct hands-on experience preparing and filing IND, NDA & BLA submissions and representing Company to FDA and other regulatory agencies Extensive knowledge of US and global regulatory requirements · Must be knowledgeable in industry trends for report and dossier preparation (e.g., IND/CTA/NDA/MAA, including electronic document submissions (i.e., eCTD). Must have thorough understanding of good clinical/laboratory or manufacturing practices, regulatory compliance and statistical reporting. Must possess the understanding of scientific methods and the ability to interpret and communicate scientific data to the FDA. Must have excellent PC, written and verbal communication skills. Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution · Self-motivated, flexible and creative leader, able to prioritize, multi-task, and work in a fast-paced & demanding environment Strong leadership skills, team player, problem solver, strategic thinker and excellent collaborater. Physical Requirements: This position primarily works in an office environment. It requires the ability to sit or stand for long periods of time and frequent walking. Daily use of a computer, phone, office equipment and other computing and digital devices is required. May be required to stand for extended periods when facilitating meetings or walking in the facilities. Some local travel may be necessary, so the ability to travel by plane, operate a motor vehicle and maintain a valid Driver's license and/or effectively navigate public transportation is required. While performing the responsibilities of the job, the employee must be able to read and respond to interoffice communications as well as effectively participate in meetings. The employee is often required to sit and use their hands and fingers, to lift up to 20 lbs., pull, push, carry, handle or feel. The employee is required to carry, handle items, reach with arms and hands, to stoop, kneel, or crouch; talk or hear. Mental demands may require prolonged concentration, reading comprehension, understanding and interpretation of concepts, ideas and philosophies. The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described unless such accommodations would cause Avanir an undue burden. Work Environment: While performing the responsibilities of the job, these work environment characteristics are representative of the environment the job holder will encounter. Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job unless such accommodations would cause Avanir an undue burden. While performing the duties of this job, the employee is occasionally exposed to moving carts, mechanical equipment (copiers, computers, coffee machines) and vehicles. May be subject to smells and odors. The noise level in the work environment is usually quiet to moderate. The passage of employees through the work area is average and normal. EEO Statement: As an equal opportunity employer, Avanir Pharmaceuticals is committed to providing all applicants and employees with equal access to employment opportunities, regardless of sex, race, age, color, national origin, ancestry, disability, pregnancy, religion, genetic information, sexual orientation transgender status, gender identity, marital status, military or veteran status, or any other characteristic protected by federal, state, or local law. All Avanir Pharmaceuticals employees, officers, principles, agents, and representatives are expressly prohibited from engaging in unlawful discrimination. Consistent with federal, state, and local requirements, Avanir Pharmaceuticals will reasonably accommodate any qualified individual with a disability if such accommodation would allow the individual to perform the essential functions or the job, unless doing so would create an undue hardship. Avanir Pharmaceuticals shall abide by the requirements of 41 CFR-60-300.5(a) and 60-741.5(a). These regulations prohibit discrimination against qualified individuals on the basis of protected veteran status or disability, and require affirmative action by covered prime contractors and subcontractors to employ and advance in employment qualified protected veterans and individuals with disabilities.
01/14/2021
Full time
The Vice President of Regulatory Affairs is responsible for providing regulatory leadership and for the planning and oversight of all regulatory submissions from pre-submission to approval of product(s)/application(s). Responsible for addressing data requirements to regulatory authorities. This position will provide the regulatory and technical expertise into the Company's development plans of its product candidates. Prepares for and expedites early and effective approval of pharmaceutical new products in accordance with regulatory strategy. They will work cross-functionally with R&D, Quality, supply chain, compliance, legal, operations, marketing and other departments. Essential Job Functions: Represents the regulatory interest of the Company by meeting with regulatory agencies Provides expert regulatory advice internally to Senior Management and Board of directors when needed to ensure compliance with FDA regulations. Effectively communicates and implements determined regulatory strategy with the appropriate departments and/or employees. Works to minimize regulatory issues and helps prevent unnecessary regulatory delays Will train staff in the preparation of documentation for regulatory review in technical areas, and performs regular evaluation Ensure compliance of Company SOPs, protocols, and specifications in order to codify procedures to be used as a reference among Company employees and contractors Perform record review to assure quality submission of regulatory documents. This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Other duties, responsibilities and activities may change or be assigned at any time with or without notice. Education/ Qualifications: BA/BS Required, MBA is a plus or equivalent experience 12+ years of regulatory experience in the pharmaceutical / biotechnology industry Must have direct hands-on experience preparing and filing IND, NDA & BLA submissions and representing Company to FDA and other regulatory agencies Extensive knowledge of US and global regulatory requirements · Must be knowledgeable in industry trends for report and dossier preparation (e.g., IND/CTA/NDA/MAA, including electronic document submissions (i.e., eCTD). Must have thorough understanding of good clinical/laboratory or manufacturing practices, regulatory compliance and statistical reporting. Must possess the understanding of scientific methods and the ability to interpret and communicate scientific data to the FDA. Must have excellent PC, written and verbal communication skills. Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution · Self-motivated, flexible and creative leader, able to prioritize, multi-task, and work in a fast-paced & demanding environment Strong leadership skills, team player, problem solver, strategic thinker and excellent collaborater. Physical Requirements: This position primarily works in an office environment. It requires the ability to sit or stand for long periods of time and frequent walking. Daily use of a computer, phone, office equipment and other computing and digital devices is required. May be required to stand for extended periods when facilitating meetings or walking in the facilities. Some local travel may be necessary, so the ability to travel by plane, operate a motor vehicle and maintain a valid Driver's license and/or effectively navigate public transportation is required. While performing the responsibilities of the job, the employee must be able to read and respond to interoffice communications as well as effectively participate in meetings. The employee is often required to sit and use their hands and fingers, to lift up to 20 lbs., pull, push, carry, handle or feel. The employee is required to carry, handle items, reach with arms and hands, to stoop, kneel, or crouch; talk or hear. Mental demands may require prolonged concentration, reading comprehension, understanding and interpretation of concepts, ideas and philosophies. The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described unless such accommodations would cause Avanir an undue burden. Work Environment: While performing the responsibilities of the job, these work environment characteristics are representative of the environment the job holder will encounter. Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job unless such accommodations would cause Avanir an undue burden. While performing the duties of this job, the employee is occasionally exposed to moving carts, mechanical equipment (copiers, computers, coffee machines) and vehicles. May be subject to smells and odors. The noise level in the work environment is usually quiet to moderate. The passage of employees through the work area is average and normal. EEO Statement: As an equal opportunity employer, Avanir Pharmaceuticals is committed to providing all applicants and employees with equal access to employment opportunities, regardless of sex, race, age, color, national origin, ancestry, disability, pregnancy, religion, genetic information, sexual orientation transgender status, gender identity, marital status, military or veteran status, or any other characteristic protected by federal, state, or local law. All Avanir Pharmaceuticals employees, officers, principles, agents, and representatives are expressly prohibited from engaging in unlawful discrimination. Consistent with federal, state, and local requirements, Avanir Pharmaceuticals will reasonably accommodate any qualified individual with a disability if such accommodation would allow the individual to perform the essential functions or the job, unless doing so would create an undue hardship. Avanir Pharmaceuticals shall abide by the requirements of 41 CFR-60-300.5(a) and 60-741.5(a). These regulations prohibit discrimination against qualified individuals on the basis of protected veteran status or disability, and require affirmative action by covered prime contractors and subcontractors to employ and advance in employment qualified protected veterans and individuals with disabilities.