- Genmab (Plainsboro, NJ)
- …to fulfilling our purpose.The RoleGenmab is looking for an Associate Director , Global Regulatory Affairs, Regulatory Strategy to be a part of our Global ... Lead(s) on a compound in late-stage development to implement the US regulatory strategy for multiple new indications. You will act as contact person with FDA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …company's growth, thereby accomplishing corporate goals.Responsibilities:Develop and implement US regulatory strategy for assigned project(s). Strategize and ... with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development...will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and partner with FDA; direct, coordinate and implement the preparation of all regulatory submissions and provide regulatory support across all global projects, ... of others (team members); meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process… more
- Genmab (Plainsboro, NJ)
- …of the time per our hybrid policy.ResponsibilitiesReporting to the Team Lead of Regulatory Strategy , Global Regulatory Affairs, the key responsibilities ... passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.In this role, the regulatory... Regulatory Affairs (GRA) organization.In this role, the regulatory leader will be primarily responsible for the development… more
- Genmab (Plainsboro, NJ)
- …our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be ... portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr... Affairs (GRA) and will report to the Sr Director , Labeling, Policy and Intelligence. The position will be… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …lives for a living. Are you ready to make a difference? The Position The Strategy Director is a senior individual contributor role, and the job function requires ... solutions and always seeks to improve working procedures, quality, and output. The Strategy Director serves as the clinical development strategy lead… more
- Merck & Co. (North Wales, PA)
- …promotional review divisions of FDA (OPDP/APLB) or experience developing/leading the regulatory strategy for a product filing/launchUnderstanding of the product ... Job DescriptionReports to the Director /Senior Director in the Office of...strategy discussions and extended team meetings and providing regulatory guidance and perspective on marketing strategies and promotion… more
- Genmab (Plainsboro, NJ)
- …our best, and authentic is essential to fulfilling our purpose.The RoleThe Associate Director , Digital Strategy - Medical/Access/PSS & Paid Media will serve as ... US. This critical role reports directly to the Senior Director of Digital Strategy and will be...effortsEnsure perspectives from key stakeholders (Ops, Privacy, Data Science, Regulatory , IT) are accounted early and oftenSpearhead novel &… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …assigned to alliance assets for operational matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. Lead and prepare FDA ... rare diseases and immune disorders. Summary: This role is responsible for providing regulatory strategic and tactical leadership, and alignment to ways of working on… more
- Merck & Co. (North Wales, PA)
- …Headquarters Principal Scientist is responsible for development and implementation of global regulatory strategy for their assigned projects in the Vaccines and ... and Clinical Safety (GRACS) and external to GRACS.Develops worldwide product regulatory strategy to optimize label and obtain shortest time to approval by… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of product messages and materials across multiple functional areas, and propose regulatory strategy and solutions to challenging promotional concepts that meet ... Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide strategic regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Summary: Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's ... into a global strategy .Responsible for ensuring aligned global regulatory strategy is endorsed by GPT and other governance bodies.Serve as a leader… 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
- Genmab (Plainsboro, NJ)
- …to be our best, and authentic is essential to fulfilling our purpose.The Role The Director of US Medical Affairs Solid Tumors Strategy will report to the Senior ... Director , US Medical Affairs Solid Tumors Strategy Lead. S/he will provide medical affairs leadership for assigned asset(s)/indications and support for the… more
- Merck & Co. (Rahway, NJ)
- …cycle of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication. --Specifically, the Director may ... breakthrough science that radically changes the way we approach serious diseases. --The Director will report to an Associate Vice President in the Oncology Clinical… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director for the Integrated Logistics Procurement & Sourcing Organization will oversee a portfolio exceeding $750 million at a global ... supply of critical medicines through our supplier network while navigating diverse regulatory landscapes and country-specific routes to market.As a member of the… more
- Merck & Co. (Rahway, NJ)
- …strategy , target product profile development, health authority interactions, global regulatory filing strategy , launch readiness reviews, organized customer ... We are seeking a talented individual to join the team as Global Marketing Director to focus on expanding and growing our product, the first-and-only HIF2 inhibitor,… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy , lead activities, and develop ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Merck & Co. (Rahway, NJ)
- …barriers to reimbursement and market access, and provide input into clinical, regulatory , payer/access, marketing and evidence generation strategy and programsIn ... Job DescriptionTitle: Associate Principal Scientist/Associate Director , Outcomes ResearchRole SummaryUnder the guidance of a senior leader, an Associate Principal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary: This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team ... operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned… more
