This position will report directly to the Head of Program Management for Regulatory Affairs. Development and maintenance of key project artifacts, ensuring that project management lifecycle has been applied to projects and documents are drafted, reviewed and approved in accordance with the RAD Program guidelines. Client Details Leading Financial Services located in New York, New York, looking for a Regulatory Project Manager. Description Management of one or more regulatory projects that span across various businesses in the Americas, and which can be part of larger globally run programs. Oversight of implementation and disciplined execution against regulatory timeline and agreed deliverables. Secure the staffing of the project team, with the support of Project Director and/or relevant governance body in charge of allocating resources. Frame the project upfront, define the most adequate governance to lead the project to success and get sign off. Gather project requirements, develop and maintain project documentation; Build/consolidate and maintain the project plan, effectively manage unplanned events, manage dependencies and critical path; Create and adhere to detailed project schedules Weekly reporting of project timelines, budgets, and issues Ensure robust documentation of project achievements, issues, risks, dependencies and escalation to management where needed. Define for the project the key milestones, impacts, risks and mitigation plan to avoid project delays and escalation process. Regular interaction with senior management stakeholders in Working Groups and Steering Committees Close collaboration with various departments, project stakeholders, and global programs to gain a full understanding of the regulations and their impact on the business Drive the project team to completion in close interaction with the Project Sponsor, ensure effective communication, continuous alignment of all contributors and timely running of governance routines; Take responsibility for - when appropriate - some of the actions and analysis related to the project, without losing focus on the roadmap. Perform project retrospective to leverage on experience and learn lessons for improvement for the future. Manage external partner(s) and ensure productive and efficient interactions, if required on a project. Undertake detailed review and management of budgets related to projects, including out of scope activities using the defined change management process. Perform other tasks or assignments, as delegated by Regulatory Affairs management. Profile Minimum bachelor's degree from reputed University with good academic record Experience using project management software Ability to adapt and work in a changing environment Logical and structured approach to planning and problem solving and decision-making Proven ability to collaborate with partners across multiple disciplines and functions, with very good interpersonal skills Readiness to work in a global, fast-paced environment and under tight timelines to deliver high-quality results Good Microsoft Office skills - Excel, Word, Visio and PowerPoint Ability to anticipate issues and aggressively drive initiatives to achieve results Job Offer Competitive compensation daily rate based on candidate's previous experience. Apply today using the link and your resume will be considered in the next 24 hours! MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
07/21/2022
Full time
This position will report directly to the Head of Program Management for Regulatory Affairs. Development and maintenance of key project artifacts, ensuring that project management lifecycle has been applied to projects and documents are drafted, reviewed and approved in accordance with the RAD Program guidelines. Client Details Leading Financial Services located in New York, New York, looking for a Regulatory Project Manager. Description Management of one or more regulatory projects that span across various businesses in the Americas, and which can be part of larger globally run programs. Oversight of implementation and disciplined execution against regulatory timeline and agreed deliverables. Secure the staffing of the project team, with the support of Project Director and/or relevant governance body in charge of allocating resources. Frame the project upfront, define the most adequate governance to lead the project to success and get sign off. Gather project requirements, develop and maintain project documentation; Build/consolidate and maintain the project plan, effectively manage unplanned events, manage dependencies and critical path; Create and adhere to detailed project schedules Weekly reporting of project timelines, budgets, and issues Ensure robust documentation of project achievements, issues, risks, dependencies and escalation to management where needed. Define for the project the key milestones, impacts, risks and mitigation plan to avoid project delays and escalation process. Regular interaction with senior management stakeholders in Working Groups and Steering Committees Close collaboration with various departments, project stakeholders, and global programs to gain a full understanding of the regulations and their impact on the business Drive the project team to completion in close interaction with the Project Sponsor, ensure effective communication, continuous alignment of all contributors and timely running of governance routines; Take responsibility for - when appropriate - some of the actions and analysis related to the project, without losing focus on the roadmap. Perform project retrospective to leverage on experience and learn lessons for improvement for the future. Manage external partner(s) and ensure productive and efficient interactions, if required on a project. Undertake detailed review and management of budgets related to projects, including out of scope activities using the defined change management process. Perform other tasks or assignments, as delegated by Regulatory Affairs management. Profile Minimum bachelor's degree from reputed University with good academic record Experience using project management software Ability to adapt and work in a changing environment Logical and structured approach to planning and problem solving and decision-making Proven ability to collaborate with partners across multiple disciplines and functions, with very good interpersonal skills Readiness to work in a global, fast-paced environment and under tight timelines to deliver high-quality results Good Microsoft Office skills - Excel, Word, Visio and PowerPoint Ability to anticipate issues and aggressively drive initiatives to achieve results Job Offer Competitive compensation daily rate based on candidate's previous experience. Apply today using the link and your resume will be considered in the next 24 hours! MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Senior Director, Global Regulatory Portfolio Lead, Global Regulatory Affairs - Rare Genetics and Hematology. This is a remote positio Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Director working on the Global Regulatory Affairs Rare Genetics and Hematology team, you will be empowered to p rovide leadership and development to global regulatory leads to ensure innovative and robust global regulatory strategies are developed to maximize regulatory success and minimize time to approval , and a typical day will include: OBJECTIVES/PURPOSE • Provides leadership and development to global regulatory leads to ensure innovative and robust global regulatory strategies are developed to maximize regulatory success and minimize time to approval. • Develops best practices and creates a strong regulatory community across the broader Global Regulatory Affairs (GRA) organization. • Serves as an influential leader within Takeda and external to Takeda, contributing to cross-functional initiatives and influencing the field as applicable. ACCOUNTABILITIES The Sr. Director will be responsible for managing direct reports and overseeing all global and US submission for an assigned portfolio of projects . These include ensuring that the direct reports have defined, developed and clearly communicated appropriate global strategies to maximize global regulatory success. The role may serve as an interim GRL on a global project team on a as needed basis. Partner with direct reports to ensure global market access consideration are being addressed and provide senior strategic input to interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable. Ensures line management and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Demonstrates ability to anticipate risks and responsible for developing solutions to identified risks and discussing with direct reports and management; understands probabilities of technical success for the solutions. Effectively represent the Global Regulatory Affairs (GRA) function in senior level interactions at internally governance technical review committees, key global health authority meetings and external partners. Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products. Participates with influence in or leads departmental and cross-functional task-forces and initiatives. Influence non-direct reports within Therapeutic Area, across GRA and across R&D. Provide regulatory strategy support to diligence for licensing opportunities as appropriate Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner. Responsible for demonstrating Takeda leadership behaviors. DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise Comprehensive understanding of the pharmaceutical industry and global regulatory strategy experience. Leadership Demonstrated ability to work across functions, regions and cultures Functional level leadership with the ability to inspire, motivate and drive results Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing Proven skills as an effective team player who can engender credibility and confidence within and outside the company Ability to distil complex issues and ideas down to simple comprehensible terms Demonstrates leadership presence and confidence Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization Builds teams across functions and geographies with individuals who have the right skills and experience to deliver on key organizational initiatives. Invests time in helping others to enhance their skills and perform at a higher level Decision-making and Autonomy Decision making responsibilities: Provide input to highly complex decisions that impact the functional area Accountable for decision making for designated function Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions Ability to incorporate feedback and ensure decisions are implemented swiftly to yield flawless execution Accountable for providing input to and implementing vision and strategy for designated scope-making, complexity of decisions, impact of decisions, problem-soliving) Interaction Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace Cultivates a broad network of relationships throughout Takeda, with affiliates and external partners, in the industry and area of expertise. Effectively represents function in negotiations with the ability to resolve conflict in a constructive manner Ability to build strong relationships and collaborate effectively with other interfacing Takeda functions Innovation Forward thinking with the ability to recommend, influence and implement organizational change and continuous innovation Comfortable challenging the status quo and bringing forward innovative solutions Ability to take risks implementing innovative solutions, accelerating time to market Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business. Role models respect and inclusion, creating a culture that fosters innovation Complexity Ability to work in a global ecosystem (internal and external) with a high degree of complexity Deep expertise required Ability to see and understand broader, enterprise level perspective EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: Advanced degree in a scientific subject area (e.g. MSc, PhD, PharmD, MD) with global oncology regulatory experience preferred. BA accepted. 12+ years of pharmaceutical industry experience. This is inclusive of 10 years of regulatory experience or combination of 8+ years regulatory and/or related experience. Preferred experience in reviewing, authoring, or managing components of regulatory submissions. Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus. Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy. Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate global regulatory strategy. Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers innovative solutions and strategies, including risk mitigation strategies. Must work well with others and within global teams. Able to bring working teams together for common objectives. Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. WHAT TAKEDA CAN OFFER YOU: 401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs Location and Salary Information: Location(s): Remote Base Salary Range: $240K-$270K based on candidate professional experience level. Employee may also be eligible for Short Term and/or Long Term incentive benefits. Employees are eligible to participate in Medical, Dental. Vision, Life Insurance, 401(k), Charitable Contribution Match, Company Holidays, Personal & Vacation Days, Student Loan Repayment Program and Paid Volunteer Time Off ..... click apply for full job details
09/25/2021
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Senior Director, Global Regulatory Portfolio Lead, Global Regulatory Affairs - Rare Genetics and Hematology. This is a remote positio Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Director working on the Global Regulatory Affairs Rare Genetics and Hematology team, you will be empowered to p rovide leadership and development to global regulatory leads to ensure innovative and robust global regulatory strategies are developed to maximize regulatory success and minimize time to approval , and a typical day will include: OBJECTIVES/PURPOSE • Provides leadership and development to global regulatory leads to ensure innovative and robust global regulatory strategies are developed to maximize regulatory success and minimize time to approval. • Develops best practices and creates a strong regulatory community across the broader Global Regulatory Affairs (GRA) organization. • Serves as an influential leader within Takeda and external to Takeda, contributing to cross-functional initiatives and influencing the field as applicable. ACCOUNTABILITIES The Sr. Director will be responsible for managing direct reports and overseeing all global and US submission for an assigned portfolio of projects . These include ensuring that the direct reports have defined, developed and clearly communicated appropriate global strategies to maximize global regulatory success. The role may serve as an interim GRL on a global project team on a as needed basis. Partner with direct reports to ensure global market access consideration are being addressed and provide senior strategic input to interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable. Ensures line management and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Demonstrates ability to anticipate risks and responsible for developing solutions to identified risks and discussing with direct reports and management; understands probabilities of technical success for the solutions. Effectively represent the Global Regulatory Affairs (GRA) function in senior level interactions at internally governance technical review committees, key global health authority meetings and external partners. Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products. Participates with influence in or leads departmental and cross-functional task-forces and initiatives. Influence non-direct reports within Therapeutic Area, across GRA and across R&D. Provide regulatory strategy support to diligence for licensing opportunities as appropriate Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner. Responsible for demonstrating Takeda leadership behaviors. DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise Comprehensive understanding of the pharmaceutical industry and global regulatory strategy experience. Leadership Demonstrated ability to work across functions, regions and cultures Functional level leadership with the ability to inspire, motivate and drive results Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing Proven skills as an effective team player who can engender credibility and confidence within and outside the company Ability to distil complex issues and ideas down to simple comprehensible terms Demonstrates leadership presence and confidence Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization Builds teams across functions and geographies with individuals who have the right skills and experience to deliver on key organizational initiatives. Invests time in helping others to enhance their skills and perform at a higher level Decision-making and Autonomy Decision making responsibilities: Provide input to highly complex decisions that impact the functional area Accountable for decision making for designated function Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions Ability to incorporate feedback and ensure decisions are implemented swiftly to yield flawless execution Accountable for providing input to and implementing vision and strategy for designated scope-making, complexity of decisions, impact of decisions, problem-soliving) Interaction Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace Cultivates a broad network of relationships throughout Takeda, with affiliates and external partners, in the industry and area of expertise. Effectively represents function in negotiations with the ability to resolve conflict in a constructive manner Ability to build strong relationships and collaborate effectively with other interfacing Takeda functions Innovation Forward thinking with the ability to recommend, influence and implement organizational change and continuous innovation Comfortable challenging the status quo and bringing forward innovative solutions Ability to take risks implementing innovative solutions, accelerating time to market Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business. Role models respect and inclusion, creating a culture that fosters innovation Complexity Ability to work in a global ecosystem (internal and external) with a high degree of complexity Deep expertise required Ability to see and understand broader, enterprise level perspective EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: Advanced degree in a scientific subject area (e.g. MSc, PhD, PharmD, MD) with global oncology regulatory experience preferred. BA accepted. 12+ years of pharmaceutical industry experience. This is inclusive of 10 years of regulatory experience or combination of 8+ years regulatory and/or related experience. Preferred experience in reviewing, authoring, or managing components of regulatory submissions. Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus. Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy. Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate global regulatory strategy. Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers innovative solutions and strategies, including risk mitigation strategies. Must work well with others and within global teams. Able to bring working teams together for common objectives. Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. WHAT TAKEDA CAN OFFER YOU: 401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs Location and Salary Information: Location(s): Remote Base Salary Range: $240K-$270K based on candidate professional experience level. Employee may also be eligible for Short Term and/or Long Term incentive benefits. Employees are eligible to participate in Medical, Dental. Vision, Life Insurance, 401(k), Charitable Contribution Match, Company Holidays, Personal & Vacation Days, Student Loan Repayment Program and Paid Volunteer Time Off ..... click apply for full job details
With operations in 35+ nations and ~ 27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! The Global Regulatory Affairs (GRA) Region North America, Therapeutic Area Lead (TA Lead) is a member of the GRA Region North America Leadership Team and contributes to the vision and goals for Global Regulatory Affairs (GRA) by: Leading and overseeing GRA Region North America regulatory teams for assigned therapeutic area. Leading the establishment and maintenance of high quality relationships with regional health authorities and collaborating with respective GRA Global Product Strategy (GPS) TA Leads & GRA CMC Site Leads to enhance these relationships. May serve as the CSL Behring primary contact for health authorities for products within the portfolio. Driving and executing comprehensive, commercially and globally aligned regulatory activities/strategies within the region for CSL Behring's product portfolio throughout development and after commercialization. Assuring a productive collaboration with key internal stakeholders, such as Regional commercial operations and affiliate regulatory affairs, to ensure successful development, strategic alignment and execution of regional regulatory strategies that result in successful applications for assigned therapeutic area, from early development to Marketing Authorization (MA), and for any post MA submissions. Contributing to Regional regulatory intelligence to account for changes in relevant regulations / laws impacting CSL Behring's business within GRA Region North America and assesses these changes for impact to the business and CSL Behring's product portfolio. May represent CSL Behring on Industry forums. Collaborating and aligning with GRA functional TA & Site Leads, as appropriate, including exchanging information on relevant topics. Act as the regional representative for the GRA Therapeutic Area Team(s) for assigned therapeutic area(s). In limited situations, may act as regional representative for specific development projects to Global Regulatory Affairs Strategy Team (GRAST) to provide regional input into the development and delivery of innovative, science-based, solution-oriented, and globally aligned regulatory strategy. Reporting Relationships: Role that this position reports to: Head, GRA Region, North America Roles that may report to this position: Regional Senior Regulatory Manager, Region, North America Regional Regulatory Manager, Region North America Regional Regulatory Scientist, Region North America Regional Regulatory Specialist, Region North America Main Responsibilities and Accountabilities: 1. Works closely with the Head, GRA Region to maintain an effective, globally minded, Global Regulatory Affairs organization that is focused on utilizing creative problem solving skills, can clearly articulate the regional regulatory perspective to stakeholders, regardless of level, and supports effective GRAST teams for assigned therapeutic area. Contributes to GRA Region Leadership Team (GRA RLT). 2. Accountable for CSL Behring's relationship with respective health authorities within the region. Ensures high quality working relationships are established and/or maintained with regional health authorities and negotiates with these authorities to achieve positive outcomes for CSL Behring. Leverages global GRA functions to support this objective, as appropriate. 3. Provides a global mindset and expertise in Regulatory Affairs to ensure that emerging trends/issues are addressed by utilizing creative problem solving skills, and proactively influences the regional regulatory strategy in alignment with the global regulatory strategy. 4. Drives and executes comprehensive, commercially and globally aligned regulatory activities within the region for assigned therapeutic area throughout development including timely and successful registration of new products and maintenance of existing products. Ensures understanding and regional alignment of regulatory activities amongst the GRA Region staff. 5. Empowers and advises the members of GRA Region Therapeutic Area to ensure that the project portfolio objectives are met within the region. Additionally, provide strategic and tactical regulatory leadership and guidance for Regional Regulatory Senior Managers/Managers, Regulatory Scientists/Specialists, as appropriate. 6. When acting as a regional representative to GRAST, provide regional regulatory perspective, advocate and drive the 'one GRA' perspective with team stakeholders. 7. Enables growth and professional development of the GRA Region team members, including succession planning for critical roles with GRALT. Ensures all team members have been trained on their role. 8. Responsible to interact with therapeutic area / site leads for all of GRA functions on a regular basis to assure the delivery of innovative and competitive solutions to accelerate program development, reduce risks and increase success rate. 9. Responsible to interact with key internal stakeholders, such as Regional Commercial Operations and affiliate regulatory affairs, on a regular basis to ensure delivery of successful applications for assigned therapeutic area, from early development to Marketing Authorization (MA), and for any post MA submissions. 10. Implements and maintains global regulatory processes and operations for GRA Region. Implement/utilize electronic systems in line with GRA Operational Excellence. Ensures all team members have been trained. 11. Represents CSL Behring on industry forums to drive changes in the regulatory environment, as appropriate. Fosters regulatory intelligence for data generated within CSL Behring, specifically in GRA Region North America Leadership Manage the Regional regulatory activities in alignment with the Global Regulatory Affairs activities. Driving Performance Sets clear expectations/objectives aligned with CSL Company Objectives Provides an appropriate balance of direction and support to manage the performance of direct reports Holds people accountable for their performance and coaches individuals as needed to ensure they contribute at the right level Evaluates performance, gives feedback and recognizes results Ensures operational efficiencies that contribute to our bottom line Building Productive Teams Partners with Human Resources to select and onboard highly-qualified candidates (both internal and external) for open positions Builds a productive, engaging team culture and climate based on trust, respect, and mutual support Clarifies team roles, goals, mission, and ground rules Builds networks with other CSL teams to support business objectives ("One CSL") When required, uses appropriate approaches to build virtual, cross-cultural, and/or cross-functional teams Developing People On-boards new hires Recognizes and develops the potential of direct reports Holds professional development and career discussions with direct reports Provides opportunities for team members to learn and grow Develops self Creating the Future Serves as a role model for CSL's Values Lives CSL's mission, vision, and strategy and develops action plans to drive strategy execution Is dedicated to fulfilling the needs of internal and external customers and stakeholders Challenges the status quo; fosters innovation and continuous improvement Applies business acumen skills to help grow the business Position Qualifications and Experience Requirements: Education A bachelor's degree in Science or Pharmacy; post-graduate degree is advantageous. Experience At minimum 10 years' experience in the pharmaceutical industry, preferably in Biologics/Research & Development/Regulatory Affairs. Some experience may be accounted for with advanced degree. At least 7 years of regulatory experience and experience in a regulatory authority facing role, supported by additional pharmaceutical /industry experience. Demonstrated working knowledge of regulatory guidelines and legislative requirements of both international and (respective) regional Regulatory Authorities. Experience in leading negotiations and facilitating resolution of issues with regulatory agencies and with positive outcomes. Experience working with external stakeholder bodies, e.g. trade associations is advantageous. Demonstrated experience in working in a complex and matrix environment with multiple stakeholders is required. Competencies ..... click apply for full job details
09/12/2021
Full time
With operations in 35+ nations and ~ 27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! The Global Regulatory Affairs (GRA) Region North America, Therapeutic Area Lead (TA Lead) is a member of the GRA Region North America Leadership Team and contributes to the vision and goals for Global Regulatory Affairs (GRA) by: Leading and overseeing GRA Region North America regulatory teams for assigned therapeutic area. Leading the establishment and maintenance of high quality relationships with regional health authorities and collaborating with respective GRA Global Product Strategy (GPS) TA Leads & GRA CMC Site Leads to enhance these relationships. May serve as the CSL Behring primary contact for health authorities for products within the portfolio. Driving and executing comprehensive, commercially and globally aligned regulatory activities/strategies within the region for CSL Behring's product portfolio throughout development and after commercialization. Assuring a productive collaboration with key internal stakeholders, such as Regional commercial operations and affiliate regulatory affairs, to ensure successful development, strategic alignment and execution of regional regulatory strategies that result in successful applications for assigned therapeutic area, from early development to Marketing Authorization (MA), and for any post MA submissions. Contributing to Regional regulatory intelligence to account for changes in relevant regulations / laws impacting CSL Behring's business within GRA Region North America and assesses these changes for impact to the business and CSL Behring's product portfolio. May represent CSL Behring on Industry forums. Collaborating and aligning with GRA functional TA & Site Leads, as appropriate, including exchanging information on relevant topics. Act as the regional representative for the GRA Therapeutic Area Team(s) for assigned therapeutic area(s). In limited situations, may act as regional representative for specific development projects to Global Regulatory Affairs Strategy Team (GRAST) to provide regional input into the development and delivery of innovative, science-based, solution-oriented, and globally aligned regulatory strategy. Reporting Relationships: Role that this position reports to: Head, GRA Region, North America Roles that may report to this position: Regional Senior Regulatory Manager, Region, North America Regional Regulatory Manager, Region North America Regional Regulatory Scientist, Region North America Regional Regulatory Specialist, Region North America Main Responsibilities and Accountabilities: 1. Works closely with the Head, GRA Region to maintain an effective, globally minded, Global Regulatory Affairs organization that is focused on utilizing creative problem solving skills, can clearly articulate the regional regulatory perspective to stakeholders, regardless of level, and supports effective GRAST teams for assigned therapeutic area. Contributes to GRA Region Leadership Team (GRA RLT). 2. Accountable for CSL Behring's relationship with respective health authorities within the region. Ensures high quality working relationships are established and/or maintained with regional health authorities and negotiates with these authorities to achieve positive outcomes for CSL Behring. Leverages global GRA functions to support this objective, as appropriate. 3. Provides a global mindset and expertise in Regulatory Affairs to ensure that emerging trends/issues are addressed by utilizing creative problem solving skills, and proactively influences the regional regulatory strategy in alignment with the global regulatory strategy. 4. Drives and executes comprehensive, commercially and globally aligned regulatory activities within the region for assigned therapeutic area throughout development including timely and successful registration of new products and maintenance of existing products. Ensures understanding and regional alignment of regulatory activities amongst the GRA Region staff. 5. Empowers and advises the members of GRA Region Therapeutic Area to ensure that the project portfolio objectives are met within the region. Additionally, provide strategic and tactical regulatory leadership and guidance for Regional Regulatory Senior Managers/Managers, Regulatory Scientists/Specialists, as appropriate. 6. When acting as a regional representative to GRAST, provide regional regulatory perspective, advocate and drive the 'one GRA' perspective with team stakeholders. 7. Enables growth and professional development of the GRA Region team members, including succession planning for critical roles with GRALT. Ensures all team members have been trained on their role. 8. Responsible to interact with therapeutic area / site leads for all of GRA functions on a regular basis to assure the delivery of innovative and competitive solutions to accelerate program development, reduce risks and increase success rate. 9. Responsible to interact with key internal stakeholders, such as Regional Commercial Operations and affiliate regulatory affairs, on a regular basis to ensure delivery of successful applications for assigned therapeutic area, from early development to Marketing Authorization (MA), and for any post MA submissions. 10. Implements and maintains global regulatory processes and operations for GRA Region. Implement/utilize electronic systems in line with GRA Operational Excellence. Ensures all team members have been trained. 11. Represents CSL Behring on industry forums to drive changes in the regulatory environment, as appropriate. Fosters regulatory intelligence for data generated within CSL Behring, specifically in GRA Region North America Leadership Manage the Regional regulatory activities in alignment with the Global Regulatory Affairs activities. Driving Performance Sets clear expectations/objectives aligned with CSL Company Objectives Provides an appropriate balance of direction and support to manage the performance of direct reports Holds people accountable for their performance and coaches individuals as needed to ensure they contribute at the right level Evaluates performance, gives feedback and recognizes results Ensures operational efficiencies that contribute to our bottom line Building Productive Teams Partners with Human Resources to select and onboard highly-qualified candidates (both internal and external) for open positions Builds a productive, engaging team culture and climate based on trust, respect, and mutual support Clarifies team roles, goals, mission, and ground rules Builds networks with other CSL teams to support business objectives ("One CSL") When required, uses appropriate approaches to build virtual, cross-cultural, and/or cross-functional teams Developing People On-boards new hires Recognizes and develops the potential of direct reports Holds professional development and career discussions with direct reports Provides opportunities for team members to learn and grow Develops self Creating the Future Serves as a role model for CSL's Values Lives CSL's mission, vision, and strategy and develops action plans to drive strategy execution Is dedicated to fulfilling the needs of internal and external customers and stakeholders Challenges the status quo; fosters innovation and continuous improvement Applies business acumen skills to help grow the business Position Qualifications and Experience Requirements: Education A bachelor's degree in Science or Pharmacy; post-graduate degree is advantageous. Experience At minimum 10 years' experience in the pharmaceutical industry, preferably in Biologics/Research & Development/Regulatory Affairs. Some experience may be accounted for with advanced degree. At least 7 years of regulatory experience and experience in a regulatory authority facing role, supported by additional pharmaceutical /industry experience. Demonstrated working knowledge of regulatory guidelines and legislative requirements of both international and (respective) regional Regulatory Authorities. Experience in leading negotiations and facilitating resolution of issues with regulatory agencies and with positive outcomes. Experience working with external stakeholder bodies, e.g. trade associations is advantageous. Demonstrated experience in working in a complex and matrix environment with multiple stakeholders is required. Competencies ..... click apply for full job details
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries. Our location in Alameda, California, currently has an opportunity for a Senior Manager, Public Affairs - Diabetes Care. The Public Affairs function for Abbott's diabetes care business has global responsibility for public relations activities for the world-leading sensing technology platform including FreeStyle Libre for people with diabetes and Abbott's Libre Sense Glucose Sport Biosensor designed for athletic performance. The successful candidate is passionate about consumer technology and its impact on human health. Seeking a candidate who is a strong storyteller in consumer, tech, and health, and has a proven-track record of top-tier media relations skills, can create compelling internal and external content, manage and anticipate crisis and issues, and develop international PR programming. The candidate will be self-motivated and nimble, thrive in a fast-paced dynamic environment, and have experience in supporting and executing successful PR and communications programs. Seeking a candidate with an ability to manage multiple projects across time zones, experience in working with other PR teams, agencies and has experience in managing crisis scenarios (pro-active and reactive), and supporting employee communications. The position will report directly to the the Head of Public Affairs for Abbott's diabetes care business. All division PA functions have a line reporting relationship to Corporate Public Affairs. WHAT YOU'LL DO Provide strategic counsel to marketing groups, internal/external clients, and country-level leadership on business-related efforts and initiatives; partner with various stakeholders including regulatory affairs, operations, quality, R&D, HR, government affairs, investor relations, legal, finance and senior management. Support the development and execution of external public relations strategies and approaches for key global product launches/filings, key clinical and real-world data, product awareness programs/outreach and influencer programming. Work extensively with U.S. and international business, including affiliates and public affairs colleagues outside of the U.S. as well as agency partners. Assist director in developing plans, content, and supporting communication needs of country managers and affiliates around the world. Oversee PR agency management and/or PR agency selection process as needed. Work extensively with top-tier business, technology, lifestyle and consumer reporters (both proactively and reactively) to enhance and protect the company's reputation as well as advance business objectives. Develop compelling consumer-focused storylines, positioning and key messaging for the business. Assist with executive communications strategy and development of internal communication materials. Identify and anticipate issues and working with appropriate functions to counsel management on reputation/business impact and influence business decision making process. Develop multimedia, content and social and digital strategies to complement key Public Affairs campaigns. Bring to the table an understanding of today's communications environment amongst earned, owned, social and paid media and how to align and maximize opportunities provided by these channels for Abbott's glucose sensing technology. Set metrics to measure effectiveness of internal and external communication efforts. Coach senior divisional executives, businesses, regions and third-party spokespeople on delivery of key messages. EDUCATION AND EXPERIENCE YOU'LL BRING Required A bachelor's degree in journalism, public relations, communications, business, marketing or related field is required. 7+ years of experience in public relations and media relations, with a deep understanding of how to use external communications to enhance reputation. Preferred Experience in healthcare, technology and/or direct-to-consumer communications preferred. Strong contacts and working relationships with a variety of top tier media. Proven ability in placing media stories and managing relationships with U.S. top-tier technology, lifestyle, consumer and business media; experience with international media and media landscapes. Consistent track record of excellent professional writing, communication and project management skills. Strong experience in developing compelling content for product communications and developing key positioning, messaging, toolkits. Experience in working in a regulated environment. Able to achieve results while dealing with ambiguity, discretion, and a rapid pace of change. Experience working with and counseling senior management. Exhibits strong judgement and executive presence. Experience in crisis communication and exhibits anticipatory thinking. Proven experience in leading digital, social media and influencer projects to build brands. WHAT WE OFFER At Abbott, you can have a good job that can grow into a great career. We offer: Training and career development, with onboarding programs for new employees and tuition assistance Financial security through competitive compensation, incentives and retirement plans Health care and well-being programs including medical, dental, vision, wellness and occupational health programs Paid time off 401(k) retirement savings with a generous company match The stability of a company with a record of strong financial performance and history of being actively involved in local communities Learn more about our benefits that add real value to your life to help you live fully: Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at , on Facebook at and on
09/11/2021
Full time
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries. Our location in Alameda, California, currently has an opportunity for a Senior Manager, Public Affairs - Diabetes Care. The Public Affairs function for Abbott's diabetes care business has global responsibility for public relations activities for the world-leading sensing technology platform including FreeStyle Libre for people with diabetes and Abbott's Libre Sense Glucose Sport Biosensor designed for athletic performance. The successful candidate is passionate about consumer technology and its impact on human health. Seeking a candidate who is a strong storyteller in consumer, tech, and health, and has a proven-track record of top-tier media relations skills, can create compelling internal and external content, manage and anticipate crisis and issues, and develop international PR programming. The candidate will be self-motivated and nimble, thrive in a fast-paced dynamic environment, and have experience in supporting and executing successful PR and communications programs. Seeking a candidate with an ability to manage multiple projects across time zones, experience in working with other PR teams, agencies and has experience in managing crisis scenarios (pro-active and reactive), and supporting employee communications. The position will report directly to the the Head of Public Affairs for Abbott's diabetes care business. All division PA functions have a line reporting relationship to Corporate Public Affairs. WHAT YOU'LL DO Provide strategic counsel to marketing groups, internal/external clients, and country-level leadership on business-related efforts and initiatives; partner with various stakeholders including regulatory affairs, operations, quality, R&D, HR, government affairs, investor relations, legal, finance and senior management. Support the development and execution of external public relations strategies and approaches for key global product launches/filings, key clinical and real-world data, product awareness programs/outreach and influencer programming. Work extensively with U.S. and international business, including affiliates and public affairs colleagues outside of the U.S. as well as agency partners. Assist director in developing plans, content, and supporting communication needs of country managers and affiliates around the world. Oversee PR agency management and/or PR agency selection process as needed. Work extensively with top-tier business, technology, lifestyle and consumer reporters (both proactively and reactively) to enhance and protect the company's reputation as well as advance business objectives. Develop compelling consumer-focused storylines, positioning and key messaging for the business. Assist with executive communications strategy and development of internal communication materials. Identify and anticipate issues and working with appropriate functions to counsel management on reputation/business impact and influence business decision making process. Develop multimedia, content and social and digital strategies to complement key Public Affairs campaigns. Bring to the table an understanding of today's communications environment amongst earned, owned, social and paid media and how to align and maximize opportunities provided by these channels for Abbott's glucose sensing technology. Set metrics to measure effectiveness of internal and external communication efforts. Coach senior divisional executives, businesses, regions and third-party spokespeople on delivery of key messages. EDUCATION AND EXPERIENCE YOU'LL BRING Required A bachelor's degree in journalism, public relations, communications, business, marketing or related field is required. 7+ years of experience in public relations and media relations, with a deep understanding of how to use external communications to enhance reputation. Preferred Experience in healthcare, technology and/or direct-to-consumer communications preferred. Strong contacts and working relationships with a variety of top tier media. Proven ability in placing media stories and managing relationships with U.S. top-tier technology, lifestyle, consumer and business media; experience with international media and media landscapes. Consistent track record of excellent professional writing, communication and project management skills. Strong experience in developing compelling content for product communications and developing key positioning, messaging, toolkits. Experience in working in a regulated environment. Able to achieve results while dealing with ambiguity, discretion, and a rapid pace of change. Experience working with and counseling senior management. Exhibits strong judgement and executive presence. Experience in crisis communication and exhibits anticipatory thinking. Proven experience in leading digital, social media and influencer projects to build brands. WHAT WE OFFER At Abbott, you can have a good job that can grow into a great career. We offer: Training and career development, with onboarding programs for new employees and tuition assistance Financial security through competitive compensation, incentives and retirement plans Health care and well-being programs including medical, dental, vision, wellness and occupational health programs Paid time off 401(k) retirement savings with a generous company match The stability of a company with a record of strong financial performance and history of being actively involved in local communities Learn more about our benefits that add real value to your life to help you live fully: Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at , on Facebook at and on
Role Summary "Pfizer Rare Disease has a robust pipeline with 4 potential launches within the next 3 years. This pipeline includes a new transformative and breakthrough Gene therapy for Duchenne Muscular Dystrophy (DMD) which is expected to be our 1st launch within this franchise as well as 3 transformative, breakthrough hemophilia agents - Hemophilia A Gene Therapy (GTx), Hemophilia B Gene Therapy, and a subcutaneously delivered monoclonal antibody to treat hemophilia A & B (marstacimab). All of these products represent significant therapeutic benefits to patients offering breakthrough innovations that address today's high burden of treatment. The hemophilia launches will continue to reinforce Pfizer's legacy and leadership in the hemophilia space while the DMD launch will potentially create the anchor brand for us in the Rare Neurology space. Beyond these launches, there are several programs in development including for Sickle Cell Disease (SCD) in the hematology space and ITP/CIDP in the neurology space. Given the multiple gene therapy launches occurring with the same time frame as well as other products in development, there is a need to develop an integrated approach to launching these products as well as ensure that there is a robust future pipeline of products to complement the growth in these two franchises. The Commercial Development & Strategy Lead, is a unique role with an opportunity to both unlock new sources of value for the franchises while also delivering on key initiatives to maximize the upcoming launches. The role will report to the Global Franchise Lead - Rare Hematology and Neurology and sit on the leadership team. She/he will be responsible for both a) strategic aspects driving commercial development and business development initiatives for the franchise and b) operational aspects supporting key pan-franchise deliverables. The selected leader will have demonstrated not only success/thriving in ambiguous situations, but also a desire to lead in this emerging field for Pfizer and the Pfizer Rare Disease portfolio. This person will need to exercise both strategic and commercial development skills - e.g. define commercial opportunity for the development programs and what is required for a successful launch as well as operational skills in leading pan franchise initiatives such as integrated Operating plan etc. In addition, collaboration within the LT as well as in engagement with cross-functional partners will be another key attribute for this role. It is expected that the person will spend approximately 50% of the time driving Comm Dev/BD activities with the other 50% towards franchise operational initiatives , but could change depending on progress of programs. Roles and Responsibilities Overall Franchise Strategy: Lead development of overall Rare Hematology and Neurology franchise strategy and prioritization Develop and maintain an integrated franchise strategy for the heme and neurology portfolio including preparing and maintaining strategy walking decks for the team. Monitor overall external landscape and partner with the Hematology and Neurology leads to maintain competitive overview of our programs. Shape external narrative, in partnership with the LT and the corporate affairs function, around Rare Hem/Neuro franchise and Pfizer's growing footprint in this space. Drive Operational excellence across Rare Heme/Neuro franchise Lead the preparation and execution of the integrated Operating plan process for the Rare Hem/Neuro franchise including continuous improvements working with the OP captains. Act as the point of contact with the Finance Lead to manage and lead the budgetary process through the year including LE submissions and buy-ups as needed. Act as the primary interface for input on and maintaining progress against RD strategy initiatives, and earnings call coordination for the heme/neuro franchise. Drive overall team culture in collaboration with the LT and also lead integrated approach for key initiatives (e.g. ways of working, townhalls/offsites etc. as needed). Commercial Development and BD Interface: Serve as Commercial Lead on Rare Neuro/Rare Heme Disease Area Working Group (DAWG) Assess current Rare Hem/Neuro landscape for potential assets and/or in-license/partnership opportunities in support of expanding the portfolio. Partner with Glocal Product Development, Global Clinical Development, Medical and Customer Analytics & Insights to develop product concepts to support the key disease state areas of interest Serve as the Commercial voice for BDPC presentation of product concepts. Serve as Commercial lead for the SCD and ITP programs for DP-3 Partner with the Early Commercial Development team (ECD) to prepare for assets prior to DP-3 to ensure seamless transition. Lead DP-3 preparation including development of market understanding, align on key assumptions for forecast modeling on a global scale. Collaborate with Chief Business Office on assessment of business development opportunities. Accountable for implementation of identified business development opportunities, incl elements of commercial assessments, forecasts and research, evaluations, and selection of opportunities and investments that have the potential to deliver the greatest value to Pfizer. Ensure valuations for medicine reflect emerging insights from development program, competitive programs, and emerging environment for pricing, reimbursement and access. Qualifications 15 years of pharmaceutical industry experience in marketing, strategy, new product launch, strategy consulting, business development in pharmaceutical or biotechnology companies. BA/BS - degree required. Advance degree preferred Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. The candidate must be a self-starter who is able to multitask in a fast-paced and dynamic environment. He/ she must be have strong learning agility and a high degree of comfort with ambiguity. Global commercial development experience or participating in pipeline/Global Medicine team helpful. Ability to rapidly comprehend scientific and clinical data; connects understanding of relationship between scientific data and unmet needs in market; translates scientific value proposition into commercial opportunity with value to the business Experience developing, representing and defending commercial opportunities, brand plans, and operating plans to senior leadership required Experience building strategic narrative incorporating internal and external variables. Financial and business planning acumen; strategic, analytical and problem solving skills. Self-motivated colleague with the ability to work independently to drive change in a dynamic environment Strong verbal and written communication skills including ability to distill messages and craft a persuasive story, communicate with clarity to partners and senior stakeholders. Ability to challenge and force a level of rigor and robustness in analyses and decision making in a consistent and thorough manner Other Job Details: Last Date to Apply for Job: September 24, 2021 Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. Marketing and Market Research #LI-PFE
09/11/2021
Full time
Role Summary "Pfizer Rare Disease has a robust pipeline with 4 potential launches within the next 3 years. This pipeline includes a new transformative and breakthrough Gene therapy for Duchenne Muscular Dystrophy (DMD) which is expected to be our 1st launch within this franchise as well as 3 transformative, breakthrough hemophilia agents - Hemophilia A Gene Therapy (GTx), Hemophilia B Gene Therapy, and a subcutaneously delivered monoclonal antibody to treat hemophilia A & B (marstacimab). All of these products represent significant therapeutic benefits to patients offering breakthrough innovations that address today's high burden of treatment. The hemophilia launches will continue to reinforce Pfizer's legacy and leadership in the hemophilia space while the DMD launch will potentially create the anchor brand for us in the Rare Neurology space. Beyond these launches, there are several programs in development including for Sickle Cell Disease (SCD) in the hematology space and ITP/CIDP in the neurology space. Given the multiple gene therapy launches occurring with the same time frame as well as other products in development, there is a need to develop an integrated approach to launching these products as well as ensure that there is a robust future pipeline of products to complement the growth in these two franchises. The Commercial Development & Strategy Lead, is a unique role with an opportunity to both unlock new sources of value for the franchises while also delivering on key initiatives to maximize the upcoming launches. The role will report to the Global Franchise Lead - Rare Hematology and Neurology and sit on the leadership team. She/he will be responsible for both a) strategic aspects driving commercial development and business development initiatives for the franchise and b) operational aspects supporting key pan-franchise deliverables. The selected leader will have demonstrated not only success/thriving in ambiguous situations, but also a desire to lead in this emerging field for Pfizer and the Pfizer Rare Disease portfolio. This person will need to exercise both strategic and commercial development skills - e.g. define commercial opportunity for the development programs and what is required for a successful launch as well as operational skills in leading pan franchise initiatives such as integrated Operating plan etc. In addition, collaboration within the LT as well as in engagement with cross-functional partners will be another key attribute for this role. It is expected that the person will spend approximately 50% of the time driving Comm Dev/BD activities with the other 50% towards franchise operational initiatives , but could change depending on progress of programs. Roles and Responsibilities Overall Franchise Strategy: Lead development of overall Rare Hematology and Neurology franchise strategy and prioritization Develop and maintain an integrated franchise strategy for the heme and neurology portfolio including preparing and maintaining strategy walking decks for the team. Monitor overall external landscape and partner with the Hematology and Neurology leads to maintain competitive overview of our programs. Shape external narrative, in partnership with the LT and the corporate affairs function, around Rare Hem/Neuro franchise and Pfizer's growing footprint in this space. Drive Operational excellence across Rare Heme/Neuro franchise Lead the preparation and execution of the integrated Operating plan process for the Rare Hem/Neuro franchise including continuous improvements working with the OP captains. Act as the point of contact with the Finance Lead to manage and lead the budgetary process through the year including LE submissions and buy-ups as needed. Act as the primary interface for input on and maintaining progress against RD strategy initiatives, and earnings call coordination for the heme/neuro franchise. Drive overall team culture in collaboration with the LT and also lead integrated approach for key initiatives (e.g. ways of working, townhalls/offsites etc. as needed). Commercial Development and BD Interface: Serve as Commercial Lead on Rare Neuro/Rare Heme Disease Area Working Group (DAWG) Assess current Rare Hem/Neuro landscape for potential assets and/or in-license/partnership opportunities in support of expanding the portfolio. Partner with Glocal Product Development, Global Clinical Development, Medical and Customer Analytics & Insights to develop product concepts to support the key disease state areas of interest Serve as the Commercial voice for BDPC presentation of product concepts. Serve as Commercial lead for the SCD and ITP programs for DP-3 Partner with the Early Commercial Development team (ECD) to prepare for assets prior to DP-3 to ensure seamless transition. Lead DP-3 preparation including development of market understanding, align on key assumptions for forecast modeling on a global scale. Collaborate with Chief Business Office on assessment of business development opportunities. Accountable for implementation of identified business development opportunities, incl elements of commercial assessments, forecasts and research, evaluations, and selection of opportunities and investments that have the potential to deliver the greatest value to Pfizer. Ensure valuations for medicine reflect emerging insights from development program, competitive programs, and emerging environment for pricing, reimbursement and access. Qualifications 15 years of pharmaceutical industry experience in marketing, strategy, new product launch, strategy consulting, business development in pharmaceutical or biotechnology companies. BA/BS - degree required. Advance degree preferred Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. The candidate must be a self-starter who is able to multitask in a fast-paced and dynamic environment. He/ she must be have strong learning agility and a high degree of comfort with ambiguity. Global commercial development experience or participating in pipeline/Global Medicine team helpful. Ability to rapidly comprehend scientific and clinical data; connects understanding of relationship between scientific data and unmet needs in market; translates scientific value proposition into commercial opportunity with value to the business Experience developing, representing and defending commercial opportunities, brand plans, and operating plans to senior leadership required Experience building strategic narrative incorporating internal and external variables. Financial and business planning acumen; strategic, analytical and problem solving skills. Self-motivated colleague with the ability to work independently to drive change in a dynamic environment Strong verbal and written communication skills including ability to distill messages and craft a persuasive story, communicate with clarity to partners and senior stakeholders. Ability to challenge and force a level of rigor and robustness in analyses and decision making in a consistent and thorough manner Other Job Details: Last Date to Apply for Job: September 24, 2021 Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. Marketing and Market Research #LI-PFE
About Lumen Lumen is guided by our belief that humanity is at its best when technology advances the way we live and work. With 450,000 route fiber miles serving customers in more than 60 countries, we deliver the fastest, most secure global platform for applications and data to help businesses, government and communities deliver amazing experiences. Learn more about Lumen's network, edge cloud, security and communication and collaboration solutions and our purpose to further human progress through technology at news.lumen.com, LinkedIn: /lumentechnologies, Facebook: /lumentechnologies, and YouTube: /lumentechnologies. The Role The Senior Corporate Counsel reports to an Associate General Counsel - Government Affairs and Public Policy in the company's State Government Affairs organization, serving as Lumen's attorney in matters before various state public utility commissions. This position works closely with Lumen's Government Affairs Directors in multiple states, as well as with policy experts and other regulatory and legislative analysts to support the company's regulatory, legislative, and business objectives. NOTE: Position could be located in Denver, Colorado, Salt Lake City, or possibly a remote location. The Main Responsibilities Represent the company before state public utility commissions in both contested case matters and in rulemaking projects, and as an advocate in other matters; from time to time represent the company before other state administrative agencies and local authorities Act as lead attorney in litigation before state public utility commissions involving complex technical, economic, legal, and policy issues, including (but not limited to) drafting of pleadings, motions, and legal briefs, presenting witnesses and conducting cross examination, and managing litigation-related tasks such as development of discovery requests, production of discovery responses, and development of witness testimony Provide expert legal advice on complex matters regarding telecommunications regulation, including drafting of legal and regulatory analyses and risk assessments Provide ongoing legal support to business units and the internal government affairs team to ensure compliance with both new and existing utility laws and regulations, and proactively monitor regulatory and legal developments that may impact the business of the company Engage with and negotiate with other parties, such as litigants, complainants, business competitors, property owners and managers, other utilities such as railroads, and state and local authorities Draft and edit letters, notices, policy statements, tariff provisions, rulemaking comments, and proposed legislation; may occasionally be required to interpret contracts and other commercial instruments and may draft or edit such documents Work closely with other internal regulatory affairs, legislative affairs, and policy experts to develop proactive strategies for achieving the business objectives of the company What We Look For in a Candidate 6-10 years of relevant legal experience, preferably with experience in state or federal administrative law or litigation related to the regulation and business of telecommunications and information services Excellent writing and oral communication skills Experience drafting relevant documents, particularly legal briefs, rulemaking comments and proposed legislation - including general familiarity with document development via Word and Excel. In-depth knowledge or demonstrated ability to gain knowledge of complex technical and economic concepts related to a network-related industry, preferably involving telecommunications and/or information technology Demonstrated leadership and teamwork skills achieving stated objectives while managing varied projects and a sometimes-heavy workload Demonstrated client relationship skills to continuously coordinate with internal business units and other internal legal groups Demonstrated self-starter requiring minimal supervision with the ability to gain required knowledge of new business and legal developments Experience in a technology-oriented business is highly preferred, experience in a telecommunications business is a plus. Must be a team player. Sound legal and business judgment. Juris Doctor from accredited law school. What to Expect Next Requisition #: 246113 EEO Statement We are committed to providing equal employment opportunities to all persons regardless of race, color, ancestry, citizenship, national origin, religion, veteran status, disability, genetic characteristic or information, age, gender, sexual orientation, gender identity, marital status, family status, pregnancy, or other legally protected status (collectively, "protected statuses"). We do not tolerate unlawful discrimination in any employment decisions, including recruiting, hiring, compensation, promotion, benefits, discipline, termination, job assignments or training. Disclaimer The above job definition information has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Job duties and responsibilities are subject to change based on changing business needs and conditions.
03/16/2021
Full time
About Lumen Lumen is guided by our belief that humanity is at its best when technology advances the way we live and work. With 450,000 route fiber miles serving customers in more than 60 countries, we deliver the fastest, most secure global platform for applications and data to help businesses, government and communities deliver amazing experiences. Learn more about Lumen's network, edge cloud, security and communication and collaboration solutions and our purpose to further human progress through technology at news.lumen.com, LinkedIn: /lumentechnologies, Facebook: /lumentechnologies, and YouTube: /lumentechnologies. The Role The Senior Corporate Counsel reports to an Associate General Counsel - Government Affairs and Public Policy in the company's State Government Affairs organization, serving as Lumen's attorney in matters before various state public utility commissions. This position works closely with Lumen's Government Affairs Directors in multiple states, as well as with policy experts and other regulatory and legislative analysts to support the company's regulatory, legislative, and business objectives. NOTE: Position could be located in Denver, Colorado, Salt Lake City, or possibly a remote location. The Main Responsibilities Represent the company before state public utility commissions in both contested case matters and in rulemaking projects, and as an advocate in other matters; from time to time represent the company before other state administrative agencies and local authorities Act as lead attorney in litigation before state public utility commissions involving complex technical, economic, legal, and policy issues, including (but not limited to) drafting of pleadings, motions, and legal briefs, presenting witnesses and conducting cross examination, and managing litigation-related tasks such as development of discovery requests, production of discovery responses, and development of witness testimony Provide expert legal advice on complex matters regarding telecommunications regulation, including drafting of legal and regulatory analyses and risk assessments Provide ongoing legal support to business units and the internal government affairs team to ensure compliance with both new and existing utility laws and regulations, and proactively monitor regulatory and legal developments that may impact the business of the company Engage with and negotiate with other parties, such as litigants, complainants, business competitors, property owners and managers, other utilities such as railroads, and state and local authorities Draft and edit letters, notices, policy statements, tariff provisions, rulemaking comments, and proposed legislation; may occasionally be required to interpret contracts and other commercial instruments and may draft or edit such documents Work closely with other internal regulatory affairs, legislative affairs, and policy experts to develop proactive strategies for achieving the business objectives of the company What We Look For in a Candidate 6-10 years of relevant legal experience, preferably with experience in state or federal administrative law or litigation related to the regulation and business of telecommunications and information services Excellent writing and oral communication skills Experience drafting relevant documents, particularly legal briefs, rulemaking comments and proposed legislation - including general familiarity with document development via Word and Excel. In-depth knowledge or demonstrated ability to gain knowledge of complex technical and economic concepts related to a network-related industry, preferably involving telecommunications and/or information technology Demonstrated leadership and teamwork skills achieving stated objectives while managing varied projects and a sometimes-heavy workload Demonstrated client relationship skills to continuously coordinate with internal business units and other internal legal groups Demonstrated self-starter requiring minimal supervision with the ability to gain required knowledge of new business and legal developments Experience in a technology-oriented business is highly preferred, experience in a telecommunications business is a plus. Must be a team player. Sound legal and business judgment. Juris Doctor from accredited law school. What to Expect Next Requisition #: 246113 EEO Statement We are committed to providing equal employment opportunities to all persons regardless of race, color, ancestry, citizenship, national origin, religion, veteran status, disability, genetic characteristic or information, age, gender, sexual orientation, gender identity, marital status, family status, pregnancy, or other legally protected status (collectively, "protected statuses"). We do not tolerate unlawful discrimination in any employment decisions, including recruiting, hiring, compensation, promotion, benefits, discipline, termination, job assignments or training. Disclaimer The above job definition information has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Job duties and responsibilities are subject to change based on changing business needs and conditions.
About us: Arcus Biosciences is an exciting growth company founded on the vision of creating best-in-class cancer therapies. We are an oncology-focused biopharmaceutical company leveraging its deep cross-discipline expertise to discover highly differentiated therapies and develop a broad portfolio of novel combinations addressing significant unmet needs. We are located in the San Francisco bay area, in the heart of the world's largest biotechnology research hub. Arcus Biosciences offers a competitive compensation and benefits package, including aggressive participation in the growth of the company in the form of stock option grants. Arcus is an ambitious undertaking, and we fully expect our company to become a force in the discovery, development and commercialization of novel therapies for the treatment of cancer. Our employees enjoy operating in an exceptionally dynamic and cooperative environment in which the "rule book" has not yet been written. Job Summary: The Regulatory Operations Associate Director is responsible for providing publishing, document processing, archiving and general submission support to the growing Regulatory Operations team. This person will help to establish the Regulatory Operations Function at Arcus and help to establish an approach for regulatory submissions. This position will provide global support to Regulatory Affairs with an immediate focus on work on submissions for the US. This person will collaborate closely with other Regulatory teams to establish the Regulatory Operations department. This person will manage the Publishing, Document Processing, and Archiving Functions. Job Responsibilities: Regulatory Operations Duties As the lead of the Regulatory Operations team, helping to establish the team and the sub functions within Arcus. Manage complex submission publishing activities associated with generating hard copy and electronic submissions. This will include working with offsite vendors and resources to produce quality dossiers. Deliver a service to our customers, through the planning, production, distribution and archiving of submissions throughout the various geographical regions. Lead strategic processes and provides strategic value to the overall positioning of the department with Arcus Lead and promotes initiatives in moving the company forward with the implementation of new systems, processes and services. Allocate project resource within the company and with offsite vendors to ensure adequate resourcing for Arcus regulatory dossiers Responsible for forward planning of Publishing resources. Has an awareness of long-term filing plans and advises senior management of resource implications. Interacts frequently with other functional areas such as IT, Clinical Operations, and Regulatory. Maintains constructive and positive interactions with colleagues. Manages multiple projects. Maintains oversight of the status of multiple projects managed by junior colleagues. Participates in cross-functional projects. Discusses the status of ongoing projects with the team, sets expectations where necessary and reports on project statuses to senior management. Takes decisions regarding issue resolution. Able to eloquently describe complex issues and recommend a resolution or workaround to senior management with appropriate consideration of possible impacts. Represent Regulatory Operations by taking the lead in submission planning meetings to help becoming familiar with the submission priorities. Interface with project managers, regulatory product managers, and/or content authors to provide guidance on submission preparation and content. Assist and/or provide training to others on software tools and educate authors on publishing policies and procedures such as StartingPoint document templates, best practice for use in the Veeva Vault RIM platform and eCTD Viewing in Rosetta Viewer. Maintain a compliant and up-to-date Regulatory Archive using Veeva Vault Archive. Develop and training on archiving process as necessary Lead the development and management of projects as applicable in support of the Regulatory Operations department. Manage and develop junior members of staff. Management Duties Task management and performance management of junior employees will be required, to include but not limited to: biannual performance reviews, goal setting, leave approval, sick leave acknowledgement, SOP compliance tracking, regular 1-1 meetings. Identifies future resourcing needs, requests requisitions with justification, reviews CVs, telephone screens, arranges face-to-face interviews with department administrator, gathers feedback and recommends the successful candidate. Manage vendor relationships including required resources, issue resolution and contract negotiation. Qualifications (including knowledge & skills): Minimum education and experience level 10+ years of relevant experience and a BA or BS or 8+years with Master or above Preferred qualifications Significant experience within a Regulatory Publishing environment including hands on eCTD experience and broad industry standard systems knowledge. Management experience is preferred. Working knowledge of business software, including: MS Word, Excel, PowerPoint, Project, Adobe Acrobat and Outlook. Experience in the preparation and submission of documents using regulatory/document management systems (e.g. VAULT®, Documentum®, FirstDocs®, Publishing Tools, and Validation tools) is required Experience with archive management Experience with vendor management is a plus Strategic thinking is required, with a focus on process improvement and optimization. Excellent verbal and written skills and attention to detail are required as well as time management and prioritization skills. Demonstrated ability to balance multiple tasks to achieve goals and to meet deadlines and customers' expectations. Relevant experience includes project coordination/management, project management systems, electronic document management systems, global regulatory submissions or other experience directly related to project management and Regulatory Operations. Familiarity with pharmaceutical development and global Regulatory submissions is required. Organized with systematic approach to prioritization Process orientated to achieve the business objective Ability to learn new technologies quickly
03/01/2021
Full time
About us: Arcus Biosciences is an exciting growth company founded on the vision of creating best-in-class cancer therapies. We are an oncology-focused biopharmaceutical company leveraging its deep cross-discipline expertise to discover highly differentiated therapies and develop a broad portfolio of novel combinations addressing significant unmet needs. We are located in the San Francisco bay area, in the heart of the world's largest biotechnology research hub. Arcus Biosciences offers a competitive compensation and benefits package, including aggressive participation in the growth of the company in the form of stock option grants. Arcus is an ambitious undertaking, and we fully expect our company to become a force in the discovery, development and commercialization of novel therapies for the treatment of cancer. Our employees enjoy operating in an exceptionally dynamic and cooperative environment in which the "rule book" has not yet been written. Job Summary: The Regulatory Operations Associate Director is responsible for providing publishing, document processing, archiving and general submission support to the growing Regulatory Operations team. This person will help to establish the Regulatory Operations Function at Arcus and help to establish an approach for regulatory submissions. This position will provide global support to Regulatory Affairs with an immediate focus on work on submissions for the US. This person will collaborate closely with other Regulatory teams to establish the Regulatory Operations department. This person will manage the Publishing, Document Processing, and Archiving Functions. Job Responsibilities: Regulatory Operations Duties As the lead of the Regulatory Operations team, helping to establish the team and the sub functions within Arcus. Manage complex submission publishing activities associated with generating hard copy and electronic submissions. This will include working with offsite vendors and resources to produce quality dossiers. Deliver a service to our customers, through the planning, production, distribution and archiving of submissions throughout the various geographical regions. Lead strategic processes and provides strategic value to the overall positioning of the department with Arcus Lead and promotes initiatives in moving the company forward with the implementation of new systems, processes and services. Allocate project resource within the company and with offsite vendors to ensure adequate resourcing for Arcus regulatory dossiers Responsible for forward planning of Publishing resources. Has an awareness of long-term filing plans and advises senior management of resource implications. Interacts frequently with other functional areas such as IT, Clinical Operations, and Regulatory. Maintains constructive and positive interactions with colleagues. Manages multiple projects. Maintains oversight of the status of multiple projects managed by junior colleagues. Participates in cross-functional projects. Discusses the status of ongoing projects with the team, sets expectations where necessary and reports on project statuses to senior management. Takes decisions regarding issue resolution. Able to eloquently describe complex issues and recommend a resolution or workaround to senior management with appropriate consideration of possible impacts. Represent Regulatory Operations by taking the lead in submission planning meetings to help becoming familiar with the submission priorities. Interface with project managers, regulatory product managers, and/or content authors to provide guidance on submission preparation and content. Assist and/or provide training to others on software tools and educate authors on publishing policies and procedures such as StartingPoint document templates, best practice for use in the Veeva Vault RIM platform and eCTD Viewing in Rosetta Viewer. Maintain a compliant and up-to-date Regulatory Archive using Veeva Vault Archive. Develop and training on archiving process as necessary Lead the development and management of projects as applicable in support of the Regulatory Operations department. Manage and develop junior members of staff. Management Duties Task management and performance management of junior employees will be required, to include but not limited to: biannual performance reviews, goal setting, leave approval, sick leave acknowledgement, SOP compliance tracking, regular 1-1 meetings. Identifies future resourcing needs, requests requisitions with justification, reviews CVs, telephone screens, arranges face-to-face interviews with department administrator, gathers feedback and recommends the successful candidate. Manage vendor relationships including required resources, issue resolution and contract negotiation. Qualifications (including knowledge & skills): Minimum education and experience level 10+ years of relevant experience and a BA or BS or 8+years with Master or above Preferred qualifications Significant experience within a Regulatory Publishing environment including hands on eCTD experience and broad industry standard systems knowledge. Management experience is preferred. Working knowledge of business software, including: MS Word, Excel, PowerPoint, Project, Adobe Acrobat and Outlook. Experience in the preparation and submission of documents using regulatory/document management systems (e.g. VAULT®, Documentum®, FirstDocs®, Publishing Tools, and Validation tools) is required Experience with archive management Experience with vendor management is a plus Strategic thinking is required, with a focus on process improvement and optimization. Excellent verbal and written skills and attention to detail are required as well as time management and prioritization skills. Demonstrated ability to balance multiple tasks to achieve goals and to meet deadlines and customers' expectations. Relevant experience includes project coordination/management, project management systems, electronic document management systems, global regulatory submissions or other experience directly related to project management and Regulatory Operations. Familiarity with pharmaceutical development and global Regulatory submissions is required. Organized with systematic approach to prioritization Process orientated to achieve the business objective Ability to learn new technologies quickly
Myovant Sciences aspires to be the leading healthcare company focused on innovative treatments for women's health and prostate cancer designed to improve the lives of millions. We are on a mission to develop and deliver empowering medicines for women's health and prostate cancer through purpose-driven science and transformative advocacy. We are looking for passionate and hard-working individuals who share our excitement for this mission. We are currently seeking a qualified, highly motivated, experienced individual for the position of Senior Manager, Regulatory Operations. The position reports to the Director, Regulatory Operations. The location of the position is in Brisbane, CA. Summary Description The Regulatory Operations Senior Manager supports a variety of activities in the Regulatory Affairs department related to regulatory operations and systems. The individual must have the ability to work independently, and also as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this job. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required. Essential Duties & Responsibilities Oversight of Myovant's Regulatory Information Management platform including file transfer, storage, tracking, and archival of Regulatory submission documents. Prepare high-quality global regulatory dossiers (electronic) according to health agency requirements and guidance for either drugs, biologics and/or gene therapy product(s); Provide oversight and support the processing of Myovant's Regulatory records within the company archive. Independently, serve as Regulatory Operations Lead for identified submission projects (including Marketing Applications). Provide guidance and partner with project teams (Regulatory Affairs and contributing business functions) supporting effective submission planning, building and dossier delivery activities; Review of regulatory documents and published dossier for technical completeness and compliance with health agency requirements; Manage various systems and tools within Regulatory (including, but not limited to, Publishing, eCTD Viewer, Authoring Templates, Regulatory Archive, Product Registration, Electronic Gateway); Contribute, and provide oversight to the maintenance of system documentation throughout the lifecycle of regulatory systems; Assess impact of regulatory changes to current work procedures, including in ex-US regions and provide necessary guidance to team; Lead and/or coordinate the development or update of regulatory processes (SOPs, Work Instructions and/or Internal Guidelines) for submission preparation (electronic or paper), support QC, and regulatory information management; Support in-house training to ensure optimal use of templates, processes and tools critical for submission documents and information management; and Functions as a change agent that can exhibit regulatory knowledge and awareness, technical competence, sound judgment and a professional demeanor. Represent Regulatory Operations in cross-functional meetings with Regulatory Affairs, Customer Service, Marketing, Supply Chain, Quality, Manufacturing Operations and Information Technology (IT). This may include Senior Leadership updates. Actively mentor and provide guidance and direction to support development of team peers. Core Competencies, Knowledge and Skill Requirements Extensive knowledge and experience with Microsoft Office Suite, Adobe Acrobat and plug-in tools, Regulatory Document and Information tools, and eCTD publishing systems Advanced understanding of relevant health agency requirements, submission standards, software validation concepts, and publishing best practices. Strong time management and organization skills Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required. Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction. Daily demonstration of a positive, 'can do' and service oriented attitude. Strong oral and written communicator; detail-oriented with a commitment to accuracy. Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks. Ability to multi-task and shift priorities quickly while working under tight deadlines. Skilled in developing collaborative internal and external relationships. Requirements Education BS/ BA in a relevant scientific discipline is preferred Experience 7 years of industry experience working in pharmaceutical drug development; previous experience in Regulatory Operations is required. TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT: Regularly required to operate standard office equipment Ability to work on a computer for extended periods of time Regularly required to sit for long periods of time, and occasionally stand and walk Regularly required to use hands to operate computer and other office equipment Close vision required for computer usage Occasionally required to stoop, kneel, climb and lift up to 20 pounds Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. If you require any accommodations, please email . Equal Employment Opportunity
01/29/2021
Full time
Myovant Sciences aspires to be the leading healthcare company focused on innovative treatments for women's health and prostate cancer designed to improve the lives of millions. We are on a mission to develop and deliver empowering medicines for women's health and prostate cancer through purpose-driven science and transformative advocacy. We are looking for passionate and hard-working individuals who share our excitement for this mission. We are currently seeking a qualified, highly motivated, experienced individual for the position of Senior Manager, Regulatory Operations. The position reports to the Director, Regulatory Operations. The location of the position is in Brisbane, CA. Summary Description The Regulatory Operations Senior Manager supports a variety of activities in the Regulatory Affairs department related to regulatory operations and systems. The individual must have the ability to work independently, and also as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this job. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required. Essential Duties & Responsibilities Oversight of Myovant's Regulatory Information Management platform including file transfer, storage, tracking, and archival of Regulatory submission documents. Prepare high-quality global regulatory dossiers (electronic) according to health agency requirements and guidance for either drugs, biologics and/or gene therapy product(s); Provide oversight and support the processing of Myovant's Regulatory records within the company archive. Independently, serve as Regulatory Operations Lead for identified submission projects (including Marketing Applications). Provide guidance and partner with project teams (Regulatory Affairs and contributing business functions) supporting effective submission planning, building and dossier delivery activities; Review of regulatory documents and published dossier for technical completeness and compliance with health agency requirements; Manage various systems and tools within Regulatory (including, but not limited to, Publishing, eCTD Viewer, Authoring Templates, Regulatory Archive, Product Registration, Electronic Gateway); Contribute, and provide oversight to the maintenance of system documentation throughout the lifecycle of regulatory systems; Assess impact of regulatory changes to current work procedures, including in ex-US regions and provide necessary guidance to team; Lead and/or coordinate the development or update of regulatory processes (SOPs, Work Instructions and/or Internal Guidelines) for submission preparation (electronic or paper), support QC, and regulatory information management; Support in-house training to ensure optimal use of templates, processes and tools critical for submission documents and information management; and Functions as a change agent that can exhibit regulatory knowledge and awareness, technical competence, sound judgment and a professional demeanor. Represent Regulatory Operations in cross-functional meetings with Regulatory Affairs, Customer Service, Marketing, Supply Chain, Quality, Manufacturing Operations and Information Technology (IT). This may include Senior Leadership updates. Actively mentor and provide guidance and direction to support development of team peers. Core Competencies, Knowledge and Skill Requirements Extensive knowledge and experience with Microsoft Office Suite, Adobe Acrobat and plug-in tools, Regulatory Document and Information tools, and eCTD publishing systems Advanced understanding of relevant health agency requirements, submission standards, software validation concepts, and publishing best practices. Strong time management and organization skills Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required. Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction. Daily demonstration of a positive, 'can do' and service oriented attitude. Strong oral and written communicator; detail-oriented with a commitment to accuracy. Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks. Ability to multi-task and shift priorities quickly while working under tight deadlines. Skilled in developing collaborative internal and external relationships. Requirements Education BS/ BA in a relevant scientific discipline is preferred Experience 7 years of industry experience working in pharmaceutical drug development; previous experience in Regulatory Operations is required. TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT: Regularly required to operate standard office equipment Ability to work on a computer for extended periods of time Regularly required to sit for long periods of time, and occasionally stand and walk Regularly required to use hands to operate computer and other office equipment Close vision required for computer usage Occasionally required to stoop, kneel, climb and lift up to 20 pounds Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. If you require any accommodations, please email . Equal Employment Opportunity
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.
Position Overview Nektar has an exciting opportunity for a Sr. Director, Drug Safety to join their team. Overall responsibility for leading the Drug Safety Team and directing the safety surveillance of all company investigational drug products in development and for managing patient safety and meeting regulatory reporting requirements.. Actively participates in the oversight of patient safety in all on-going clinical trials. Directs and conducts ongoing safety surveillance of company drug products. Analyses changing risk/benefit profile of company drugs in clinical trials to identify potential safety signals and implements appropriate safety updates and risk mitigation plans. Manages compliance with SOPs and FDA and global regulations for the reporting of adverse events to regulatory authorities. Serves as medical safety expert for all products in various stages of development. Lead role to help respond to and resolve safety questions from regulatory authorities, as well as regulatory agency audits and corrective action plans. Manages internal staff and external resources to ensure delivery of quality pharmacovigilance servicses. Directs the development and preparation of reports for company management, as well as for external regulatory agencies. Directs the development and preparation of periodic and annual safety reports , investigator communications,product labeling/package inserts and other reports as necessary. Provides strategic planning, implementation, and management of drug safey operations to support clinical development of company products. Provides medical expert safety review input into all critical documents for clinical development of products. Helps select, develop,train, and evaluate personnel to ensure the efficient operation of the drug safety function. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs. Consistently works on abstract problems across functional areas of clinical development and medical affairs. Identifies and evaluates fundamental issues, providing strategy and direction for major functional areas involved with clinical development of pharmaceutical/biotech products. Interacts internally and externally with executive level management requiring negotiation of extremely difficult matters to influence policymaking bodies. Leads and directs the Drug Safety Team and all aspects of drug safety related to all company sponsored clinical development activities to manage patient safety and compliance with regulatory reporting requirements. Actively participates in oversight of patient safety in all on-going clinical trials. Directs and conducts ongoing safety surveillance of company drug products. Manages internal staff and external resources to ensure delivery of quality pharmacovigilance services. Negotiates contracts, interacts and supervises the activities of contract organizations and consultants for pharmacovigilance services. Provides ongoing advice to senior management on the changing risk-benefit profile of company drug products in clinical trials, based on analyses/evaluation of potential safety signals and implements appropriate safety updates and risk mitigation plans. Provides oversight of all clinical safety services including review of medical coding of adverse event data and management of SAEs through the entire lifecycle including preparation of similar-event analyses for unexpected and related serious adverse events (SAEs) from clinical trials. Manages compliance with SOPs, and FDA and global regulations for the reporting of adverse events to regulatory agencies, IRB/Ethics committees and Investigators. Serves as the medical safety expert for all products at all stages of clinical development (Phase 1, 2 and 3 and post-approval). Plays lead role to help respond to and resolve safety questions from regulatory authorities, as well as regulatory agency audits and corrective action plans. Supports drug safety function and effectively interfaces with all relevant cross functional departments and personnel to ensure safety training and compliance, and readiness level to pass internal/external audits. Directs the development and preparation of reports for company management, as well as for external regulatory agencies. Directs the development, preparation and compliance of periodic and annual safety reports (eg. US IND annual progress reports, EU annual safety reports, periodic line listings, NDA safety updates, etc.), investigator communications, product labeling/package inserts and other reports as necessary. Provides strategic planning, implementation, and management of drug safey operations to support clinical development of company products. Participates with other senior managers to establish strategic plans for the clinical development plan of investigational products. Provides medical expert safety review input into all critical documents for clinical development of products (eg. protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, , INDs, CTAs, etc). Establishes and manages independent Data Safety Monitoring Boards (DSMBs) for clinical studies, if required. Performs research on safety profiles of competitor products within therapeutic areas of interest to help develop effective competitive strategies, for clinical development of company drug products. Helps recruit and select personnel, and provides training, development, coaching and regular performance review feedback to direct reports. Participates in corporate development of methods, techniques and evaluation criteria for projects, programs, and people. Ensures departmental budgets and schedules meet corporate requirements. An MD degree is required. A minimum of 9 years of relevant drug safety experience is required. A minimum of 7 years previous management experience may be required. An in-depth knowledge and thorough understanding of FDA, EU, and global regulations, ICH guidelines, and GCPs that govern drug safety and pharmacovigilance are required. Experience with safety databases, and expertise in clinical safety assessments, safety signal detection and risk management, including interactions with regulatory authorities are required. Must be able to demonstrate extensive experience in the design of clinical studies and have a strong working knowledge of safety reviews for input into critical documents for drug development. Strong oral and written communication skills are required. Must have a demonstrated ability to solve problems with innovative solutions along with strong organizational skills. Excellent written and verbal communication skills are required. Previous experience working with senior management is required. Experience in conducting formal presentations to Sr. Management and key opinion leaders is required. Ability to research and understand the safety profiles of competitor products within therapeutic areas of interest to help develop effective competitive strategies, as well as an in-depth understanding of clinical product development in the pharmaceutical industry. Strong analytical skills, especially with regard to understanding and interpreting scientific research and literature are essential. Knowledge of GMP and GLP is preferred. Must be a demonstrated self-starter and team player with strong interpersonal skills. Must have strong computer skills with a proficiency in various software applications (eg. Microsoft Project, Word, Excel, Visio, PowerPoint). We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.
01/28/2021
Full time
Position Overview Nektar has an exciting opportunity for a Sr. Director, Drug Safety to join their team. Overall responsibility for leading the Drug Safety Team and directing the safety surveillance of all company investigational drug products in development and for managing patient safety and meeting regulatory reporting requirements.. Actively participates in the oversight of patient safety in all on-going clinical trials. Directs and conducts ongoing safety surveillance of company drug products. Analyses changing risk/benefit profile of company drugs in clinical trials to identify potential safety signals and implements appropriate safety updates and risk mitigation plans. Manages compliance with SOPs and FDA and global regulations for the reporting of adverse events to regulatory authorities. Serves as medical safety expert for all products in various stages of development. Lead role to help respond to and resolve safety questions from regulatory authorities, as well as regulatory agency audits and corrective action plans. Manages internal staff and external resources to ensure delivery of quality pharmacovigilance servicses. Directs the development and preparation of reports for company management, as well as for external regulatory agencies. Directs the development and preparation of periodic and annual safety reports , investigator communications,product labeling/package inserts and other reports as necessary. Provides strategic planning, implementation, and management of drug safey operations to support clinical development of company products. Provides medical expert safety review input into all critical documents for clinical development of products. Helps select, develop,train, and evaluate personnel to ensure the efficient operation of the drug safety function. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs. Consistently works on abstract problems across functional areas of clinical development and medical affairs. Identifies and evaluates fundamental issues, providing strategy and direction for major functional areas involved with clinical development of pharmaceutical/biotech products. Interacts internally and externally with executive level management requiring negotiation of extremely difficult matters to influence policymaking bodies. Leads and directs the Drug Safety Team and all aspects of drug safety related to all company sponsored clinical development activities to manage patient safety and compliance with regulatory reporting requirements. Actively participates in oversight of patient safety in all on-going clinical trials. Directs and conducts ongoing safety surveillance of company drug products. Manages internal staff and external resources to ensure delivery of quality pharmacovigilance services. Negotiates contracts, interacts and supervises the activities of contract organizations and consultants for pharmacovigilance services. Provides ongoing advice to senior management on the changing risk-benefit profile of company drug products in clinical trials, based on analyses/evaluation of potential safety signals and implements appropriate safety updates and risk mitigation plans. Provides oversight of all clinical safety services including review of medical coding of adverse event data and management of SAEs through the entire lifecycle including preparation of similar-event analyses for unexpected and related serious adverse events (SAEs) from clinical trials. Manages compliance with SOPs, and FDA and global regulations for the reporting of adverse events to regulatory agencies, IRB/Ethics committees and Investigators. Serves as the medical safety expert for all products at all stages of clinical development (Phase 1, 2 and 3 and post-approval). Plays lead role to help respond to and resolve safety questions from regulatory authorities, as well as regulatory agency audits and corrective action plans. Supports drug safety function and effectively interfaces with all relevant cross functional departments and personnel to ensure safety training and compliance, and readiness level to pass internal/external audits. Directs the development and preparation of reports for company management, as well as for external regulatory agencies. Directs the development, preparation and compliance of periodic and annual safety reports (eg. US IND annual progress reports, EU annual safety reports, periodic line listings, NDA safety updates, etc.), investigator communications, product labeling/package inserts and other reports as necessary. Provides strategic planning, implementation, and management of drug safey operations to support clinical development of company products. Participates with other senior managers to establish strategic plans for the clinical development plan of investigational products. Provides medical expert safety review input into all critical documents for clinical development of products (eg. protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, , INDs, CTAs, etc). Establishes and manages independent Data Safety Monitoring Boards (DSMBs) for clinical studies, if required. Performs research on safety profiles of competitor products within therapeutic areas of interest to help develop effective competitive strategies, for clinical development of company drug products. Helps recruit and select personnel, and provides training, development, coaching and regular performance review feedback to direct reports. Participates in corporate development of methods, techniques and evaluation criteria for projects, programs, and people. Ensures departmental budgets and schedules meet corporate requirements. An MD degree is required. A minimum of 9 years of relevant drug safety experience is required. A minimum of 7 years previous management experience may be required. An in-depth knowledge and thorough understanding of FDA, EU, and global regulations, ICH guidelines, and GCPs that govern drug safety and pharmacovigilance are required. Experience with safety databases, and expertise in clinical safety assessments, safety signal detection and risk management, including interactions with regulatory authorities are required. Must be able to demonstrate extensive experience in the design of clinical studies and have a strong working knowledge of safety reviews for input into critical documents for drug development. Strong oral and written communication skills are required. Must have a demonstrated ability to solve problems with innovative solutions along with strong organizational skills. Excellent written and verbal communication skills are required. Previous experience working with senior management is required. Experience in conducting formal presentations to Sr. Management and key opinion leaders is required. Ability to research and understand the safety profiles of competitor products within therapeutic areas of interest to help develop effective competitive strategies, as well as an in-depth understanding of clinical product development in the pharmaceutical industry. Strong analytical skills, especially with regard to understanding and interpreting scientific research and literature are essential. Knowledge of GMP and GLP is preferred. Must be a demonstrated self-starter and team player with strong interpersonal skills. Must have strong computer skills with a proficiency in various software applications (eg. Microsoft Project, Word, Excel, Visio, PowerPoint). We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.
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 . Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions and driving results. What Your New Manager Wants You To Know The Associate Director Regulatory Affairs represents Regulatory Affairs for pharmaceutical development projects and marketed products. Responsible for development and communication of all aspects of regulatory strategy on R&D project teams. Works with a team of regulatory professionals to assure successful planning and completion of regulatory activities on a worldwide basis. Responsible for knowledge of regulatory requirements of major regions (e.g. US, Canada EU, APAC) with responsibility for working with colleagues on a worldwide basis to support the global strategy. Responsible for content of all regulatory submissions. Acts as primary contact for the US FDA. Directs communications and interactions with US FDA and other regulatory agencies as assigned. Ensures technical accuracy and regulatory compliance of all submissions. Ensures that all submissions are made on time. Primary responsibility is in the Neuroscience TA. YOU ARE more than just a title, YOU ARE... First class team player : collaborate across multiple disciplines to ensure compliance and ability to influence cross-functional teams and senior leadership. You Will Represent Department on Global Project Team. Develop regulatory strategic plan in consultation with the global regulatory project team. Work with team to resolve complex project issues. Utilize regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure governmental approvals are obtained. Set strategy for submissions of product registration documents to Health Authorities. Interact with other line functions in the preparation, review, and completion of documents for regulatory submissions. Responsible for US and Canada submissions (strategy and submission preparation). Clearly articulate regulatory strategy at Global Regulatory Project Team meetings. Negotiate with teams to assure acceptance of regulatory strategy. Assure compliance with project team timelines and milestones. Effectively plan, organize, and conduct formal meetings with regulatory agencies. Interact with key personnel in regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues, and the approval of marketing applications. Provide interpretive analyses of complex regulatory guidance documents, regulations, or directives that impact Abbvie's products and operations. Advise personnel in other departments regarding their applicability and impact. #LI-PD1 Qualifications You Bring Education equivalent to a PhD or MD degree or equivalent in a scientific field, plus at least 6 years' experience in Regulatory Affairs with successful leadership roles on global project teams; or Education equivalent to a MS degree or equivalent in a scientific field, plus at least 8 years' experience in Regulatory Affairs with successful leadership roles on global project teams; or Education equivalent to a BS degree or equivalent in a scientific field, plus at least 10 years' experience in Regulatory Affairs with successful leadership roles on global project teams; Demonstrated excellence in developing global regulatory affairs strategy Expert knowledge of US, Canada and ICH regulations. Experience with European, Japanese and Chinese regulations is a plus. Ability to travel up to 15% In this role, we're looking for a leader who will : • Act as an Owner • Be Excellence Focused • Act as an Influencer Significant Work Activities N/A Travel Yes, 15 % 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.
01/23/2021
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 . Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions and driving results. What Your New Manager Wants You To Know The Associate Director Regulatory Affairs represents Regulatory Affairs for pharmaceutical development projects and marketed products. Responsible for development and communication of all aspects of regulatory strategy on R&D project teams. Works with a team of regulatory professionals to assure successful planning and completion of regulatory activities on a worldwide basis. Responsible for knowledge of regulatory requirements of major regions (e.g. US, Canada EU, APAC) with responsibility for working with colleagues on a worldwide basis to support the global strategy. Responsible for content of all regulatory submissions. Acts as primary contact for the US FDA. Directs communications and interactions with US FDA and other regulatory agencies as assigned. Ensures technical accuracy and regulatory compliance of all submissions. Ensures that all submissions are made on time. Primary responsibility is in the Neuroscience TA. YOU ARE more than just a title, YOU ARE... First class team player : collaborate across multiple disciplines to ensure compliance and ability to influence cross-functional teams and senior leadership. You Will Represent Department on Global Project Team. Develop regulatory strategic plan in consultation with the global regulatory project team. Work with team to resolve complex project issues. Utilize regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure governmental approvals are obtained. Set strategy for submissions of product registration documents to Health Authorities. Interact with other line functions in the preparation, review, and completion of documents for regulatory submissions. Responsible for US and Canada submissions (strategy and submission preparation). Clearly articulate regulatory strategy at Global Regulatory Project Team meetings. Negotiate with teams to assure acceptance of regulatory strategy. Assure compliance with project team timelines and milestones. Effectively plan, organize, and conduct formal meetings with regulatory agencies. Interact with key personnel in regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues, and the approval of marketing applications. Provide interpretive analyses of complex regulatory guidance documents, regulations, or directives that impact Abbvie's products and operations. Advise personnel in other departments regarding their applicability and impact. #LI-PD1 Qualifications You Bring Education equivalent to a PhD or MD degree or equivalent in a scientific field, plus at least 6 years' experience in Regulatory Affairs with successful leadership roles on global project teams; or Education equivalent to a MS degree or equivalent in a scientific field, plus at least 8 years' experience in Regulatory Affairs with successful leadership roles on global project teams; or Education equivalent to a BS degree or equivalent in a scientific field, plus at least 10 years' experience in Regulatory Affairs with successful leadership roles on global project teams; Demonstrated excellence in developing global regulatory affairs strategy Expert knowledge of US, Canada and ICH regulations. Experience with European, Japanese and Chinese regulations is a plus. Ability to travel up to 15% In this role, we're looking for a leader who will : • Act as an Owner • Be Excellence Focused • Act as an Influencer Significant Work Activities N/A Travel Yes, 15 % 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.
Ipsen Biopharmaceuticals, Inc.
Cambridge, Massachusetts
Title: Director, Global Regulatory Affairs, Oncology Company: Ipsen Bioscience, Inc. Job Description: Overall Accountability Accountable for the development, flawless execution and implementation of regulatory strategies activities for the assigned programs for assigned region or worldwide, working with R&D, Franchise, Operations and within the regulatory science community to bring innovative and compliant approaches to the development and maintenance of those products. Product/Project Leadership Accountable for the development and continuous adaptation of the regulatory strategies for all assigned programs within the assigned portfolio, either directly or through the supervision of the Regulatory Team: Provide regulatory input into target product profile (target indications, therapeutic positioning, and key differentiating characteristics). Provide regulatory input into the Integrated Development Plan. In collaboration with other Research & Development departments, define the optimal plan to reach the target product profile, taking into consideration the most favorable timing for all key markets. Continuously evaluate the global match between development objectives and current plan versus new key findings and regulatory requirements. In collaboration with R&D, Franchise, Operations and Project Teams, ensure plan adaptation when needed. Assess impact on timelines and/or label; proposes remediation where possible. With R&D, Franchise, Operations and Project Teams, define appropriate strategy in terms of sequencing of indications, dosage forms and geographies. Establish optimal label with appropriate balance between commercial expectations, regulatory requirements, and development outcomes. Identify opportunities and limiting factors for optimal label and propose alternative solutions. Incorporate commercialization challenges into regulatory strategy (not limited to trademarks, licensing agreements, product sourcing, legal status, distribution channels). Carry strategy beyond Marketing Authorization, to incorporate Pricing & Reimbursement considerations, in collaboration with Health Outcomes and Pharmacoeconomics. With Franchise, contribute to the definition of the appropriate strategy for the assigned product. Consider regulatory avenues to maximize intellectual property protection and data exclusivity. In collaboration with other GMRS functions ensure the establishment of CCDS and required safety plans for the assigned product. Ensure regional regulatory specificities and needs are incorporated into the global plans though collaboration with local and intercontinental RA where available. Define and execute strategy for regulatory consultation (e.g. Scientific Advice, FDA planned meetings, regulatory boards). Advocates to and seeks buy-in from senior leaders in Ipsen and Health Authorities to proposed strategies Responsible for ensuring potential risks have been identified and mitigation options proactively proposed for project team and senior management decision making. Accountable for the flawless execution and implementation of the related Global Regulatory plans and activities with internal or external resources as appropriate and by using Ipsen tools and processes. Responsible for ensuring outsourced activities are delivered on time and on budget. Responsible for identifying and alerting management regarding any service issues. Review and input to all key documentation relevant to Franchise plans as required. Responsible for conducting regulatory due diligence assessment on external opportunities Lead operational excellence initiatives within GRA Regulatory Intelligence Accountable for continuously monitoring the scientific evolution of the assigned diseases within the therapeutic area for its regulatory impact; incorporates external environment into plans. Accountable for collecting, recording and sharing of competitive regulatory information for Ipsen competitor products for the assigned disease areas within the therapeutic area. Responsible for monitoring the external environment to identify trends and assess potential impact on business and communicates this information to stakeholders in a timely and compelling way Responsible for promoting activities and processes to reinforce good external influencing behaviors in the GRA organization Building Relationships with Regulators Build effective relationships with global regulators for professional communications on Ipsen strategy in relation to assigned products/disease areas. Communication Ensures timely and accurate information of regulatory developments to all stakeholders (Management, governance committees, development and commercialization teams, Public Affairs, Legal, Investor Relations, etc.). Budget Contribute towards effective planning of the GRA budget. Ethics and Compliance Accountable for ensuring all activities are conducted in line with Ipsen's ethics and compliance policies. Experience / Qualifications Proven experience of drug development and managing complex worldwide products/projects within a relevant therapeutic area, in key geographies. Track record of building excellent relationships with FDA. Knowledge of EU and Asia Pacific (mainly China and Japan) regulatory environment would be a plus. Knowledge of medical device / drug device combination regulations would be a plus. Prior experience with hematological malignancies and solid tumors helpful. Advanced degree (or equivalent) in scientific discipline (not limited to Pharmacy, Medicine, Chemistry, Biological Sciences). Significant experience in the pharmaceutical industry, including minimum 10 years in Regulatory Affairs. Key Required Technical Competencies Excellent written and oral communication skills and delivers all communication with clarity and impact. Commands attention through a range of communication styles. Ability to distil key information from complex and extensive sources and present the information in a constructive way. Solid project management skills with proven ability to develop and implement longer term plans or delivery of large-scale projects. Consistent ability to foster strong matrix working. Proven track record of facilitating groups of individuals to work together on innovative regulatory solutions. Strong interpersonal and negotiation skills with a proven ability to build strong personal networks, both within and outside Ipsen and use them to secure appropriate support and outcome for a project. Proven capability to influence decision makers both internally and externally Strategic thinking with a proven ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulation in all regions. Shows a constant focus on improving performance and excellence in all tasks. Challenges and questions ways of working to seek improved process. Capable of seeing opportunities and revising process or approach to reduce barriers for others to be able to deliver more. Proven ability to lead change and communicate difficult messages effectively. IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.","datePosted":"2020-12-08T00:00:00.000Z
01/23/2021
Full time
Title: Director, Global Regulatory Affairs, Oncology Company: Ipsen Bioscience, Inc. Job Description: Overall Accountability Accountable for the development, flawless execution and implementation of regulatory strategies activities for the assigned programs for assigned region or worldwide, working with R&D, Franchise, Operations and within the regulatory science community to bring innovative and compliant approaches to the development and maintenance of those products. Product/Project Leadership Accountable for the development and continuous adaptation of the regulatory strategies for all assigned programs within the assigned portfolio, either directly or through the supervision of the Regulatory Team: Provide regulatory input into target product profile (target indications, therapeutic positioning, and key differentiating characteristics). Provide regulatory input into the Integrated Development Plan. In collaboration with other Research & Development departments, define the optimal plan to reach the target product profile, taking into consideration the most favorable timing for all key markets. Continuously evaluate the global match between development objectives and current plan versus new key findings and regulatory requirements. In collaboration with R&D, Franchise, Operations and Project Teams, ensure plan adaptation when needed. Assess impact on timelines and/or label; proposes remediation where possible. With R&D, Franchise, Operations and Project Teams, define appropriate strategy in terms of sequencing of indications, dosage forms and geographies. Establish optimal label with appropriate balance between commercial expectations, regulatory requirements, and development outcomes. Identify opportunities and limiting factors for optimal label and propose alternative solutions. Incorporate commercialization challenges into regulatory strategy (not limited to trademarks, licensing agreements, product sourcing, legal status, distribution channels). Carry strategy beyond Marketing Authorization, to incorporate Pricing & Reimbursement considerations, in collaboration with Health Outcomes and Pharmacoeconomics. With Franchise, contribute to the definition of the appropriate strategy for the assigned product. Consider regulatory avenues to maximize intellectual property protection and data exclusivity. In collaboration with other GMRS functions ensure the establishment of CCDS and required safety plans for the assigned product. Ensure regional regulatory specificities and needs are incorporated into the global plans though collaboration with local and intercontinental RA where available. Define and execute strategy for regulatory consultation (e.g. Scientific Advice, FDA planned meetings, regulatory boards). Advocates to and seeks buy-in from senior leaders in Ipsen and Health Authorities to proposed strategies Responsible for ensuring potential risks have been identified and mitigation options proactively proposed for project team and senior management decision making. Accountable for the flawless execution and implementation of the related Global Regulatory plans and activities with internal or external resources as appropriate and by using Ipsen tools and processes. Responsible for ensuring outsourced activities are delivered on time and on budget. Responsible for identifying and alerting management regarding any service issues. Review and input to all key documentation relevant to Franchise plans as required. Responsible for conducting regulatory due diligence assessment on external opportunities Lead operational excellence initiatives within GRA Regulatory Intelligence Accountable for continuously monitoring the scientific evolution of the assigned diseases within the therapeutic area for its regulatory impact; incorporates external environment into plans. Accountable for collecting, recording and sharing of competitive regulatory information for Ipsen competitor products for the assigned disease areas within the therapeutic area. Responsible for monitoring the external environment to identify trends and assess potential impact on business and communicates this information to stakeholders in a timely and compelling way Responsible for promoting activities and processes to reinforce good external influencing behaviors in the GRA organization Building Relationships with Regulators Build effective relationships with global regulators for professional communications on Ipsen strategy in relation to assigned products/disease areas. Communication Ensures timely and accurate information of regulatory developments to all stakeholders (Management, governance committees, development and commercialization teams, Public Affairs, Legal, Investor Relations, etc.). Budget Contribute towards effective planning of the GRA budget. Ethics and Compliance Accountable for ensuring all activities are conducted in line with Ipsen's ethics and compliance policies. Experience / Qualifications Proven experience of drug development and managing complex worldwide products/projects within a relevant therapeutic area, in key geographies. Track record of building excellent relationships with FDA. Knowledge of EU and Asia Pacific (mainly China and Japan) regulatory environment would be a plus. Knowledge of medical device / drug device combination regulations would be a plus. Prior experience with hematological malignancies and solid tumors helpful. Advanced degree (or equivalent) in scientific discipline (not limited to Pharmacy, Medicine, Chemistry, Biological Sciences). Significant experience in the pharmaceutical industry, including minimum 10 years in Regulatory Affairs. Key Required Technical Competencies Excellent written and oral communication skills and delivers all communication with clarity and impact. Commands attention through a range of communication styles. Ability to distil key information from complex and extensive sources and present the information in a constructive way. Solid project management skills with proven ability to develop and implement longer term plans or delivery of large-scale projects. Consistent ability to foster strong matrix working. Proven track record of facilitating groups of individuals to work together on innovative regulatory solutions. Strong interpersonal and negotiation skills with a proven ability to build strong personal networks, both within and outside Ipsen and use them to secure appropriate support and outcome for a project. Proven capability to influence decision makers both internally and externally Strategic thinking with a proven ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulation in all regions. Shows a constant focus on improving performance and excellence in all tasks. Challenges and questions ways of working to seek improved process. Capable of seeing opportunities and revising process or approach to reduce barriers for others to be able to deliver more. Proven ability to lead change and communicate difficult messages effectively. IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.","datePosted":"2020-12-08T00:00:00.000Z
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? Since 2013, Novartis Gene Therapies (formerly AveXis) has had one focus: bringing change to those devastated by genetic diseases. The Novartis Gene Therapies culture embraces this mission. As a compassionate and dedicated team, we are enthusiastic about the science behind our work and finding answers to difficult questions. We are dedicated to communities affected by rare diseases, and these patients and families are the motivation for everything we do. We have built a team with exceptional depth of experience, unified by a common vision; to develop gene therapies with the potential to positively impact the lives of the patients and families devastated by rare and life-threatening neurological genetic diseases. Though we are proud of what we have achieved to date, we remain relentlessly focused on making that vision a reality. The Sr. Director, Geneconomics Cost Modeler, is responsible for developing and implementing (hands on) global strategic economic research and cost models for managing the planning, implementation and publishing of health economics and cost models in disease areas of interest to Novartis Gene Therapies and through the product life cycle. This role oversees cost models conducted for company products and shares that research with other Novartis Gene Therapies stakeholders and regions. Responsibilities Provides insights to Early Development, Clinical R&D Commercial/Marketing/Translational Access, Medical Affairs regarding the development of Novartis Gene Therapies products. Designs cost modeling studies to quantify product value including clinical and/or economic impacts of gene therapy products. Conducts, develops, and validates health economic cost models and analysis, including but not limited to cost effectiveness, cost utility, cost minimization, cost benefit, and budget impact models, using published literature, clinical trial data and/or real world data inputs. Adapts economic models in accordance with local requirements / guidelines. Contributes to HTA submission documentation and tactics, and to pricing and reimbursement (pricing corridor, economically justifiable price, launch sequence/timing, negotiation argumentation). Leads the development of cost models project deliverables: models, reports, abstracts, manuscripts, and slide decks. Reviews and critiques medical and evidence-based health economic literature & statistical analyses in geneconomics. Presents and interprets findings to cross functional teams, including global patient access, clinical development, medical affairs, marketing team, and publication teams. Leverages EHR databases to support model development and reimbursement activities. Obtains value evidence scientific advice from HTAs / Payers and regulatory regarding cost models evidence package. Responds to external reviews and needs such as ICER, local HTAs (NICE, HAS, etc.) and engage external HEOR KOLs. Researches and performs critical economic analyses of medical and scientific evidence including systematic reviews and economic evaluations as the basis for HTA assessments and formulary evaluations. Contributes to the development of high quality global value and AMCP dossiers. Collaborates on the development of Quality of Life measures to generate utilities to be used in cost models. Attends HEOR, medical/scientific, and pharmacy professional meetings to keep up with changing trends and remain current within the field relating to modeling and new research trends affecting each product area. Oversees operation, resourcing and management of the modeling activities. Other related job duties as assigned. Qualifications MD, PhD or Master's degree in economics, health economics, public health, health policy and management, statistics, operational research or related field and 10 years relevant experience. 7 years demonstrated experience in economic modeling. Working knowledge of health economic modeling techniques, including decision analysis. Hand-on experience of using Markov model and discrete event simulation. Experience of using Tableau is preferred. Expert-level proficiency in Microsoft Excel (including Visual Basic), Treeage, and/or R. Possesses excellent HTA, Payer and reimbursement knowledge. Experience working in a global organization highly desirable. Experience working in a matrixed environment highly desirable. Record of publications in health economics, health services research, or clinical journals. Hand-on experience of cost-effectiveness analysis and/or budget impact analysis Proven ability to write and publish for medical or scientific audiences. Extensive working knowledge of ICER and HTAs needs and processes. Strong skills in data analytics and graphic interfaces. Strong organizational skills and proven ability to manage personal responsibilities on multiple priorities and/or projects at once. Ability to work independently and collaboratively. Outstanding ability to communicate technical and complex information to both technical and non-technical audiences. Possess strong business acumen in understanding the needs from ICER, HTAs and payers. Possesses excellent communication and interpersonal skills especially over departmental and geographical boundaries. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Novartis Gene Therapies is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-SN1
01/22/2021
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? Since 2013, Novartis Gene Therapies (formerly AveXis) has had one focus: bringing change to those devastated by genetic diseases. The Novartis Gene Therapies culture embraces this mission. As a compassionate and dedicated team, we are enthusiastic about the science behind our work and finding answers to difficult questions. We are dedicated to communities affected by rare diseases, and these patients and families are the motivation for everything we do. We have built a team with exceptional depth of experience, unified by a common vision; to develop gene therapies with the potential to positively impact the lives of the patients and families devastated by rare and life-threatening neurological genetic diseases. Though we are proud of what we have achieved to date, we remain relentlessly focused on making that vision a reality. The Sr. Director, Geneconomics Cost Modeler, is responsible for developing and implementing (hands on) global strategic economic research and cost models for managing the planning, implementation and publishing of health economics and cost models in disease areas of interest to Novartis Gene Therapies and through the product life cycle. This role oversees cost models conducted for company products and shares that research with other Novartis Gene Therapies stakeholders and regions. Responsibilities Provides insights to Early Development, Clinical R&D Commercial/Marketing/Translational Access, Medical Affairs regarding the development of Novartis Gene Therapies products. Designs cost modeling studies to quantify product value including clinical and/or economic impacts of gene therapy products. Conducts, develops, and validates health economic cost models and analysis, including but not limited to cost effectiveness, cost utility, cost minimization, cost benefit, and budget impact models, using published literature, clinical trial data and/or real world data inputs. Adapts economic models in accordance with local requirements / guidelines. Contributes to HTA submission documentation and tactics, and to pricing and reimbursement (pricing corridor, economically justifiable price, launch sequence/timing, negotiation argumentation). Leads the development of cost models project deliverables: models, reports, abstracts, manuscripts, and slide decks. Reviews and critiques medical and evidence-based health economic literature & statistical analyses in geneconomics. Presents and interprets findings to cross functional teams, including global patient access, clinical development, medical affairs, marketing team, and publication teams. Leverages EHR databases to support model development and reimbursement activities. Obtains value evidence scientific advice from HTAs / Payers and regulatory regarding cost models evidence package. Responds to external reviews and needs such as ICER, local HTAs (NICE, HAS, etc.) and engage external HEOR KOLs. Researches and performs critical economic analyses of medical and scientific evidence including systematic reviews and economic evaluations as the basis for HTA assessments and formulary evaluations. Contributes to the development of high quality global value and AMCP dossiers. Collaborates on the development of Quality of Life measures to generate utilities to be used in cost models. Attends HEOR, medical/scientific, and pharmacy professional meetings to keep up with changing trends and remain current within the field relating to modeling and new research trends affecting each product area. Oversees operation, resourcing and management of the modeling activities. Other related job duties as assigned. Qualifications MD, PhD or Master's degree in economics, health economics, public health, health policy and management, statistics, operational research or related field and 10 years relevant experience. 7 years demonstrated experience in economic modeling. Working knowledge of health economic modeling techniques, including decision analysis. Hand-on experience of using Markov model and discrete event simulation. Experience of using Tableau is preferred. Expert-level proficiency in Microsoft Excel (including Visual Basic), Treeage, and/or R. Possesses excellent HTA, Payer and reimbursement knowledge. Experience working in a global organization highly desirable. Experience working in a matrixed environment highly desirable. Record of publications in health economics, health services research, or clinical journals. Hand-on experience of cost-effectiveness analysis and/or budget impact analysis Proven ability to write and publish for medical or scientific audiences. Extensive working knowledge of ICER and HTAs needs and processes. Strong skills in data analytics and graphic interfaces. Strong organizational skills and proven ability to manage personal responsibilities on multiple priorities and/or projects at once. Ability to work independently and collaboratively. Outstanding ability to communicate technical and complex information to both technical and non-technical audiences. Possess strong business acumen in understanding the needs from ICER, HTAs and payers. Possesses excellent communication and interpersonal skills especially over departmental and geographical boundaries. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Novartis Gene Therapies is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-SN1
Global Blood Therapeutics
San Francisco, California
SENIOR MANAGER, REGULATORY AFFAIRS CMC Position Summary: The Senior Manager, Regulatory Affairs CMC will provide regulatory guidance on global Chemistry, Manufacturing and Controls (CMC) regulatory activities for Global Blood Therapeutics (GBT) compounds (small molecule) for the treatment of sickle cell disease (SCD) and other disorders. Responsibility will focus mainly on CMC regulatory filings, and providing strategic as well as operational management of the project teams in this area. In addition, responsibilities may include support to on-going clinical activities. The candidate will develop regulatory strategies and manage US and ex-US clinical applications and marketing applications, FDA and other regulatory interactions (responses to requests for information), for the product candidates. This will be an individual contributor and will report to Sr. Director, RA CMC. Essential Duties and Responsibilities: Manage internal review / approval process for CMC related submissions and regulatory questions; manage internal stakeholder meetings, adjudications meetings, and maintain internal trackers and databases, as appropriate Provide interpretation of regulatory authorities' feedback, policies and guidelines to GBT personnel. Support GBT during regulatory authority inspections on designated programs Develop regulatory strategic plans in conjunction with project teams and assist in the preparation of CMC submissions required for regulatory approval Work with project teams to resolve complex project issues. Utilize regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure regulatory agency approvals are obtained Responsible for supporting the filing of IND/CTA/NDA/MAA submissions. Support strategy developed for submissions of product registration documents to health authorities worldwide. Interact with other functions and external vendors, as necessary, in the preparation, review, and completion of documents for regulatory submissions Support the planning and preparation of formal meetings with regulatory agencies. Assure compliance with project team timelines and milestones Contribute to the preparation of regulatory impact assessments for change control management and deviation reports Accrue regulatory intelligence on the regions of interest for GBT products and educate the department of RA at large on the evolution of the regulatory landscape Qualifications: Bachelor degree in a Chemistry, Life Sciences or equivalent, advanced degree preferred. 6-9+years of relevant experience (at least 3 years of Regulator Affairs CMC experience) and has earned a BS or equivalent degree Experience providing guidance to team members Experience in eCTD format and structure Balance strategic thinking and strong analytical skills with ability to execute. Detail oriented with strong written, verbal communication and presentation skills Strong project management skills. Experience with international and particularly EU regulatory submissions and an understanding of worldwide small molecule guidelines and regulations a plus Demonstrated excellence in regulatory liaison/strategy Strategic thinking, leadership skills, assertiveness, strong technical background, and excellent negotiation and project management skills as evidenced by past performance on drug development project teams Can prioritize deadlines, projects, and adapt to quickly changing environment Can maintain excellent relationships with peers, despite workoad pressure and tight timelines Fit with GBT culture: Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Excitement about the vision and mission of GBT Integrity Values-based leadership Flexibility NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
01/21/2021
Full time
SENIOR MANAGER, REGULATORY AFFAIRS CMC Position Summary: The Senior Manager, Regulatory Affairs CMC will provide regulatory guidance on global Chemistry, Manufacturing and Controls (CMC) regulatory activities for Global Blood Therapeutics (GBT) compounds (small molecule) for the treatment of sickle cell disease (SCD) and other disorders. Responsibility will focus mainly on CMC regulatory filings, and providing strategic as well as operational management of the project teams in this area. In addition, responsibilities may include support to on-going clinical activities. The candidate will develop regulatory strategies and manage US and ex-US clinical applications and marketing applications, FDA and other regulatory interactions (responses to requests for information), for the product candidates. This will be an individual contributor and will report to Sr. Director, RA CMC. Essential Duties and Responsibilities: Manage internal review / approval process for CMC related submissions and regulatory questions; manage internal stakeholder meetings, adjudications meetings, and maintain internal trackers and databases, as appropriate Provide interpretation of regulatory authorities' feedback, policies and guidelines to GBT personnel. Support GBT during regulatory authority inspections on designated programs Develop regulatory strategic plans in conjunction with project teams and assist in the preparation of CMC submissions required for regulatory approval Work with project teams to resolve complex project issues. Utilize regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure regulatory agency approvals are obtained Responsible for supporting the filing of IND/CTA/NDA/MAA submissions. Support strategy developed for submissions of product registration documents to health authorities worldwide. Interact with other functions and external vendors, as necessary, in the preparation, review, and completion of documents for regulatory submissions Support the planning and preparation of formal meetings with regulatory agencies. Assure compliance with project team timelines and milestones Contribute to the preparation of regulatory impact assessments for change control management and deviation reports Accrue regulatory intelligence on the regions of interest for GBT products and educate the department of RA at large on the evolution of the regulatory landscape Qualifications: Bachelor degree in a Chemistry, Life Sciences or equivalent, advanced degree preferred. 6-9+years of relevant experience (at least 3 years of Regulator Affairs CMC experience) and has earned a BS or equivalent degree Experience providing guidance to team members Experience in eCTD format and structure Balance strategic thinking and strong analytical skills with ability to execute. Detail oriented with strong written, verbal communication and presentation skills Strong project management skills. Experience with international and particularly EU regulatory submissions and an understanding of worldwide small molecule guidelines and regulations a plus Demonstrated excellence in regulatory liaison/strategy Strategic thinking, leadership skills, assertiveness, strong technical background, and excellent negotiation and project management skills as evidenced by past performance on drug development project teams Can prioritize deadlines, projects, and adapt to quickly changing environment Can maintain excellent relationships with peers, despite workoad pressure and tight timelines Fit with GBT culture: Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Excitement about the vision and mission of GBT Integrity Values-based leadership Flexibility NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
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 . This position is responsible for overseeing International Public Affairs strategies and tactics to drive AbbVie's business in Oncology and Specialty Care, including Virology and Neuroscience. The role reports to the Senior Director, International Public Affairs and has accountability for the outcome of communication and patient relations activities within Oncology and Specialty, that have an impact on the broader reputation of the Company. The role sits on Oncology and Specialty leaderships for Global Marketing and Commercial Operations (GMCO), Global Commercial Development (GCD), as well on the respective TA Strategy Councils (TASCs) and relevant Asset Strategy Teams (AST), to contribute to the development of business strategies and acts as a strategic counsellor to these teams. This role also must work very closely with all relevant departments within AbbVie, particularly Corporate Responsibility, Communications and Brand, Marketing, Medical, Regulatory, Government Affairs, Market Access, HEOR and others, as relevant. The role manages three direct reports and an annual budget of ~$3MM. Major Accountabilities Specific functions performed include strategic stakeholder engagement for Oncology and Specialty, oversee affiliate launch readiness and conduct general affiliate preparedness. The role also oversees media relations and issues management for the respective TAs. Manages and develops a public affairs team responsible for developing communications strategies and plans that support overall business objectives for on-market and pipeline compounds. Has functional accountability over affiliate launch success for Oncology and Specialty medicines Has functional accountability over global brand plan execution for Oncology and Specialty marketed medicines. Provides strategic counsel and contributes significantly to the decisions of management, Oncology and Specialty leaderships, global brand teams and other internal stakeholders on courses of action to address proactive opportunities and manage issues. Links brand and therapeutic area public affairs strategies to overall CRBC strategic roadmap priorities. Works collaboratively with Areas and Affiliates, leading the co-creation of therapeutic area programs/plans against a strategic communications plan that advances brand reputation, shapes the healthcare environment and advances understanding of priority disease areas and the success of AbbVie medicines as defined by the global brand teams. Analyzes the surrounding environment and gathers stakeholder insights to inform global strategic planning, objectives and key business decisions. Anticipates potential issues and develop/implement appropriate actions to protect the Company and brands he/she is responsible for. Works closely with media from relevant countries to build an understanding and appreciation of the therapeutic area, brand(s), the Company and business priorities. Establishes media engagement plans that elevate the reputation of the brand(s), as per the priorities defined in collaboration with the brand teams. Acts as spokesperson where relevant. Develops and leads strategic patient advocacy programs, builds rapport and manages relationships with prioritized advocacy groups and patient organizations. Can oversee the strategy and execution of internal communication programs on behalf of the global teams. Facilitates internal global best practice sharing on brand communications. Consistently measures the success of the initiatives developed against the set of goals and integrates the learnings back into strategy design seeking permanent improvement. Supervises PR firms, outside vendors, contractors, etc. Responsible for talent development and succession planning for direct reports. Manages the department budget; oversees PR spend of several million dollars. Complies and is an advocate for the company's policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives of AbbVie. Qualifications Qualification Requirements Minimum of Bachelor's degree in communications, PR, marketing or related field. Minimum 10-15 years of directly relevant communications experience with international healthcare and/or industry experience required. Very strong business and marketing acumen. Demonstrated expertise in developing and executing insight-driven, strategic and measurable external public relations programs on behalf of pharmaceutical and/or consumer products. Proven track record of working with senior executives and leading teams. Strong understanding about the value of public relations and its role in the integrated marketing mix. Ability to provide strategic counsel for a variety of communications scenarios and to a variety of internal and external stakeholders. Exceptional verbal and written communication skills. Proven creativity, strategic, analytical and leadership capabilities. Demonstrated ability to work effectively in cross-functional teams and with multiple internal and external stakeholders; influence/negotiation skills and relationship management capabilities a must. Experience counselling senior business leaders on diverse, high profile and financially-material topics. Proven experience in issues/crises management. Strong interpersonal skills to quickly build rapport and credibility with AbbVie affiliates and leaders as well as other key internal and external stakeholders. Significant Work Activities N/A Travel Yes, 20 % of the Time 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.
01/20/2021
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 . This position is responsible for overseeing International Public Affairs strategies and tactics to drive AbbVie's business in Oncology and Specialty Care, including Virology and Neuroscience. The role reports to the Senior Director, International Public Affairs and has accountability for the outcome of communication and patient relations activities within Oncology and Specialty, that have an impact on the broader reputation of the Company. The role sits on Oncology and Specialty leaderships for Global Marketing and Commercial Operations (GMCO), Global Commercial Development (GCD), as well on the respective TA Strategy Councils (TASCs) and relevant Asset Strategy Teams (AST), to contribute to the development of business strategies and acts as a strategic counsellor to these teams. This role also must work very closely with all relevant departments within AbbVie, particularly Corporate Responsibility, Communications and Brand, Marketing, Medical, Regulatory, Government Affairs, Market Access, HEOR and others, as relevant. The role manages three direct reports and an annual budget of ~$3MM. Major Accountabilities Specific functions performed include strategic stakeholder engagement for Oncology and Specialty, oversee affiliate launch readiness and conduct general affiliate preparedness. The role also oversees media relations and issues management for the respective TAs. Manages and develops a public affairs team responsible for developing communications strategies and plans that support overall business objectives for on-market and pipeline compounds. Has functional accountability over affiliate launch success for Oncology and Specialty medicines Has functional accountability over global brand plan execution for Oncology and Specialty marketed medicines. Provides strategic counsel and contributes significantly to the decisions of management, Oncology and Specialty leaderships, global brand teams and other internal stakeholders on courses of action to address proactive opportunities and manage issues. Links brand and therapeutic area public affairs strategies to overall CRBC strategic roadmap priorities. Works collaboratively with Areas and Affiliates, leading the co-creation of therapeutic area programs/plans against a strategic communications plan that advances brand reputation, shapes the healthcare environment and advances understanding of priority disease areas and the success of AbbVie medicines as defined by the global brand teams. Analyzes the surrounding environment and gathers stakeholder insights to inform global strategic planning, objectives and key business decisions. Anticipates potential issues and develop/implement appropriate actions to protect the Company and brands he/she is responsible for. Works closely with media from relevant countries to build an understanding and appreciation of the therapeutic area, brand(s), the Company and business priorities. Establishes media engagement plans that elevate the reputation of the brand(s), as per the priorities defined in collaboration with the brand teams. Acts as spokesperson where relevant. Develops and leads strategic patient advocacy programs, builds rapport and manages relationships with prioritized advocacy groups and patient organizations. Can oversee the strategy and execution of internal communication programs on behalf of the global teams. Facilitates internal global best practice sharing on brand communications. Consistently measures the success of the initiatives developed against the set of goals and integrates the learnings back into strategy design seeking permanent improvement. Supervises PR firms, outside vendors, contractors, etc. Responsible for talent development and succession planning for direct reports. Manages the department budget; oversees PR spend of several million dollars. Complies and is an advocate for the company's policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives of AbbVie. Qualifications Qualification Requirements Minimum of Bachelor's degree in communications, PR, marketing or related field. Minimum 10-15 years of directly relevant communications experience with international healthcare and/or industry experience required. Very strong business and marketing acumen. Demonstrated expertise in developing and executing insight-driven, strategic and measurable external public relations programs on behalf of pharmaceutical and/or consumer products. Proven track record of working with senior executives and leading teams. Strong understanding about the value of public relations and its role in the integrated marketing mix. Ability to provide strategic counsel for a variety of communications scenarios and to a variety of internal and external stakeholders. Exceptional verbal and written communication skills. Proven creativity, strategic, analytical and leadership capabilities. Demonstrated ability to work effectively in cross-functional teams and with multiple internal and external stakeholders; influence/negotiation skills and relationship management capabilities a must. Experience counselling senior business leaders on diverse, high profile and financially-material topics. Proven experience in issues/crises management. Strong interpersonal skills to quickly build rapport and credibility with AbbVie affiliates and leaders as well as other key internal and external stakeholders. Significant Work Activities N/A Travel Yes, 20 % of the Time 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.
