- Aequor (Newbury Park, CA)
- …for inclusion in regulatory submissions. Coordination and execution of regulatory affairs processes and deliverables. Works under under the direction ... zone based on business needs in the evenings. Ideal Candidate: Previous Regulatory Experience professionally is highly preferred. Knowledge of FDA. Degree in life… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …As a result, this role will need to partner closely with teams and senior leaders from across Regulatory Affairs , as well as cross-functional ... Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, reporting, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Eisai, Inc (Nutley, NJ)
- …key business processes. Responsible for approval of medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs and Commercial ... your profile, we want to hear from you.The Medical Director, US Medical Affairs provides medical leadership for medical affairs strategy, planning and supportive… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …activities and ways of working. This role will also work with the Global Regulatory Affairs Leadership Team (GRA-LT) to define DS' priorities, strategy and ... MD, JD preferred Experience Qualifications7 or More Years Experience in pharma Regulatory Affairs , with at least 3 years developing regulatory strategies… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …leadership while driving results.Collaborate with internal and external stakeholdersInteract with senior CSPV/ Medical Affairs leadership teams to ensure Quality ... centered around rare diseases and immune disorders. Summary The Senior Director, Head Global PV Quality (DSI/DSE) reports to...key business function and collaborate with RD and Medical Affairs Quality to provide clinical safety QA advise wherever… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both internal ... Development, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams to deliver and drive the timely… more
- Eisai, Inc (Nutley, NJ)
- …hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning and supportive tactics mainly for GU therapeutic area. This ... working with key stakeholders to develop and execute the medical affairs plan, including data generations (including RWE), post-marketing research, medical… more
- Merck & Co. (North Wales, PA)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.- Specifically, the Senior Director… more
- Merck & Co. (Rahway, NJ)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May… more
- Merck & Co. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. Specifically, The Senior Clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …creation of developmental and regulatory strategy in collaboration with Regulatory Affairs ; Drafts clinical development plans, protocol profiles and sections ... indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; Represents clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the Product Material Review Team (PMRT) with the Legal, and Medical Affairs departments, ensuring consistency of materials across brands and departments, adherence ... cross functional assistance for PGC, Learning Management System (LMS) and Regulatory , as needed. ResponsibilitiesEditorial Review of Materials Review and consult… more
- Lundbeck (Chicago, IL)
- …include continuous collaboration with all relevant support departments: marketing, medical affairs , regulatory , IT, sales operations, commercial analytics, etc., ... of growth!Open to candidates anywhere in the greater United StatesSUMMARY:The Senior Manager Sales Training and Development is primarily responsible for managing… more
- Eisai, Inc (Nutley, NJ)
- …Functions Medical Affairs Strategic Plans: Under the direction of the Senior Medical Director, work with key stakeholders, management, and functional area leads ... for assigned therapeutic area. Under the direction of the Senior Medical Director, this role will be responsible for...Responsible for approval of medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …BD&L. Collaborates with cross-functional teams, including portfolio, marketing, medical, R&D, regulatory affairs , analytics, and other relevant NNI departments ... states. Work collaboratively with cross-functional teams including research and development, regulatory affairs , and commercial teams, to align product… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …sales, marketing, medical affairs , market access and policy/advocacy (MAPA), regulatory affairs , and other relevant NNI departments to ensure alignment ... strategies, and marketing promotion. Act as a liaison between marketing, medical affairs , and market access. Essential Functions US therapeutic area Strategy and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , and other relevant NNI departments to ensure alignment ... providing regular updates to leadership Product Evolution: Oversee product strategy and regulatory activities related to new clinical data or label changes. Lead… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , other relevant NNI departments, and external stakeholders ... development and/or life cycle activities Health Systems strategy: Collaborates with medical affairs and market access teams to inform a health systems strategy to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy align with regulatory requirements and compliance standards. Collaborate with regulatory affairs and compliance teams to navigate regulatory ... navigating the evolving landscape of healthcare and technology integration. This is a senior level strategic thinker who is leading a complex role in understanding… more
