- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose.The RoleGenmab is looking for an Associate Director , Global Regulatory Affairs , Regulatory Strategy ... to be a part of our Global Regulatory Affairs organization.In this role, you will work in close collaboration with the Global Regulatory Lead(s) on a… more
- Genmab (Plainsboro, NJ)
- …is looking for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.In this role, the regulatory ... hybrid policy.ResponsibilitiesReporting to the Team Lead of Regulatory Strategy, Global Regulatory Affairs , the key responsibilities include but are not… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational ... leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may...pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …. Brings issues with regard to ways or working or resources to the Head of US Regulatory Affairs and/or Global Regulatory Lead for asset to reach ... issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned... global product team meetings to provide US regulatory support and guidance as needed and manage day-to-day… more
- Merck & Co. (North Wales, PA)
- …corporate standards and policies and business objectives.Actively participate in labeling and global regulatory team meetings to ensure support for anticipated ... Job DescriptionReports to the Director /Senior Director in the Office of...all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Genmab (Plainsboro, NJ)
- …the needs of the US healthcare market through collaboration with US Commercialization, Global Medical Affairs , Clinical Development, Regulatory , and other ... be our best, and authentic is essential to fulfilling our purpose.The RoleThe Associate Director of US Medical Affairs Solid Tumors Strategy will report to the… more
- Genmab (Plainsboro, NJ)
- …the needs of the US healthcare market through collaboration with US Commercialization, Global Medical Affairs , Clinical Development, Regulatory , and other ... authentic is essential to fulfilling our purpose.The Role The Director of US Medical Affairs Solid Tumors... strategic and tactical planning in coordination with the Global Medical Affairs and other cross-functional teams.Represent… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Regional Director of Medical Affairs (RDMA) for Thoracic Malignancies holds primary responsibility for the development and execution of ... regional oncology Medical Affairs strategies and plans for Thoracic Malignancies in the...training both internally and externally in collaboration with the global scientific training and content teamsCoordinates, presents at and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …maintaining technical training programs related to GxP, Clinical, Medical and Regulatory affairs , Patient Safety required A thorough understanding and ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...ready to make a difference? The Position The Senior Director of CMR Knowledge & Technical Advancement (KTA) Department… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs , Data Management, Biostatistics, Non-clinical, Medical ... About the Department Our East Coast Global Development Hub brings together the best minds...external stakeholders. Relationships This position will report to Senior Director or Executive Director Safety Surveillance, US… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Medical Team, at the discretion of the Executive Director Represent NNI Medical Affairs on Global Core Medical Team (CMT) Collaborate with HEOR to provide ... Area in certain instances, at the discretion of Executive Director of Medical Affairs . Assists the Senior...Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs , Data Management, Biostatistics, Non-clinical, Medical ... About the Department Our East Coast Global Development Hub brings together the best minds...external stakeholders. Relationships This position will report to Executive Director of Global Safety US East Coast… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryReporting to the Senior Director , I&A, the Associate Director , Global Oncology Forecasting ... drive creation of demand and revenue forecasts. The Associate Director is a dynamic member of the Global...with Market Research, Competitive Intelligence, Marketing, MA, R&D, Finance, Regulatory and Market Access internally across global … more
- Genmab (Plainsboro, NJ)
- …to be our best, and authentic is essential to fulfilling our purpose.The RoleThe Director Global Market Access & Pricing Hematology will be responsible for ... is hybrid based in Princeton NJ (US) and will report to the Senior Director Global Access and Pricing. ResponsibilitiesLead the development of Global … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs , Quantitative Clinical Pharmacology, Clinical Safety and ... Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs , Translational Research, Research, Informatics Services, Project Management and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Clinical Directors, Medical Affairs directors, HEOR Directors, Market Access director , Marking directors and Global Project Vice Presidents (PVPs). The ... Novo Nordisk Inc (NNI) including Clinical Development, Medical, & Regulatory Affairs (CMR), Commercial Strategy & Marketing,...Global HQ and NNI. In addition, the Strategy Director may represent NNI on Global Project… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs , Data Management, Biostatistics, Non-clinical, Medical ... professionals, HAs, ECs, DMCs, and Academia. L ine management responsibility of Director /Associate Director Global Safety Lead, Senior Global Safety… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …team members, Global commercial and New Product Planning teams, Medical Affairs , Regulatory Affairs , Legal, and Market Access. Collaborates closely ... Nordisk, you will have the opportunity to build a life-changing career in a global business environment. We encourage our employees to make the most of their talent,… 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 ... Job DescriptionOur company is a global health care leader with a diversified portfolio...regulatory reporting, and publication. - Specifically, the Senior Director may be responsible for Evaluating pre-clinical and translational… more
