- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you. Job Summary The Executive Director , Regulatory Affairs will provide leadership and direction for the global ... on the project team throughout the product lifecycle. Provide senior staff advice and guidance on regulatory ...Salary Transparency Language:The base salary range for the Executive Director , Global Regulatory Affairs -… more
- Merck & Co. (Upper Gwynedd, PA)
- …- Associate Principal Scientist, CMC, R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal Scientist/ Sr Principal Scientist in ... issues to GRACS CMC management, as neededDemonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies required Travel: Ability ... centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic… more
- Twist BioScience (South San Francisco, CA)
- …and infrastructure teams, Manufacturing Operations, Quality Assurance, Process Development, and Regulatory Affairs teams to define MES requirements, design ... Sr . Director , Manufacturing Execution System (MES)...our proprietary MES technologies will ensure strict adherence to regulatory requirements, optimize complex biological manufacturing processes, and align… more
- Novo Nordisk Inc. (WA)
- …colleagues locally and globally. Relationships Reports to the Market Access and Public Affairs Senior Director , Policy. Other internal relationships include ... About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare...in Plainsboro, NJ or Washington, DC. The Position The Director - US Tax, Trade, IP works on complex… more
- Genmab (NJ)
- … policy and/or intelligence deliverables. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr . Director , Labeling, Policy ... like a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with customers. Relationships This position reports into a Vice President or Sr . Director within the National Account Market Access Teams. Internally, ... About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. Associate Director , Medical Education - Oncology, is responsible for the strategic planning and execution ... of relevant medical communications deliverables aligned with the Medical Affairs strategic plan for assigned therapeutic area(s). These deliverables include… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …brand performance in alignment with overall business objectives. Relationships Reports to the Sr . Director , Wegovy Consumer Marketing . C ollaborates with sales, ... in? Are you ready to experiment with us? The Position The Associate Director Consumer Marketing will be responsible for supporting the development and execution of… more
- Merck & Co. (Rahway, NJ)
- …integrating state-of-the-art technology and applying rigorous scientific and ethical standards.The Senior Director has primary responsibility for the planning ... development (pre-clinical to post-licensure). With a focus on late-stage development, the Senior Director will manage the entire cycle of clinical development,… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole SummaryThe Principal Scientist/ Director , Value & Implementation (V&I) Outcomes Research, position resides in the V&I organization, which includes ... Global Medical and Scientific Affairs as well as Outcomes Research, and will support...and will support Pneumococcal Vaccines.Under the guidance of a senior leader, this position supports value evidence outcomes research… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ensure consistency with brand/therapy area vision and message. Relationships Reports to Senior Director of Cardio Renal Marketing Responsible for providing ... affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , other relevant NNI departments, and external stakeholders… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole SummaryUnder the guidance of a senior leader, an Associate Principal Scientist/Associate Director , has primary responsibility for ... is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates. The incumbent… more
- Merck & Co. (North Wales, PA)
- …role will focus on supporting HPV. Under the guidance of an Executive Director , within the Value and Implementation, Outcomes Research the incumbent has the ... of patient reported outcomes, epidemiological studies and economic modeling.The Director also works closely with Product Development Teams, Franchise Teams,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …other functional teams in NNI (including MAPA), including marketing, medical, R&D, regulatory affairs , finance, NNGlobal, and other relevant entities to develop ... design pull you in? Are you ready to experiment with us? The Position The Director Channel Strategy & Planning will play a critical role in shaping the future… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Finance, Customer Call Center, Enterprise Insights, Supply Chain, Procurement, Public Affairs , Public Policy, Regulatory , Legal, IT, Trade, Patient Safety ... reporting requirements and operational assessments. Relationships Reports to the Director , Patient Support Transformation and Enablement. Works closely with Market… more
- Ascendis Pharma (Palo Alto, CA)
- …the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology. The Sr . Director , Regulatory Affairs will serve as the ... trials as well as Life Cycle Management Strategies. The Sr . Director will work closely with the...devastating diseases. This position will report to the VP, Regulatory Affairs and ideally be based in… more
- Vistra (Shippingport, PA)
- …that are currently available and apply online. **Job Summary** The Director , Regulatory Affairs is a senior leadership role responsible for overseeing ... upgrades, or decommissioning. + Lead, mentor, and develop a team of regulatory affairs professionals, fostering a culture of accountability, compliance, and… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …to learn, grow and become your best self. Become a **maker of possible** with us. The Sr . Director , Regulatory Affairs is the ranking Regulatory ... with RA business partners, provides input into the budget process for Regulatory Affairs + Represents the Platform in interactions/negotiations with global… more
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