- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. SummaryThe Associate Director , Global Medical Affairs (GMA) Oncology- Medical ... internal global medical education trainings to support regional medical affairs team needs.ResponsibilitiesEnsure high quality, scientifically sound Global… more
- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose.The Role As part of our expanding US Medical Affairs (USMA) team, Genmab is seeking a Senior Director , USMA ... Solid Tumor Portfolio. This role will report to the VP/Head of US Medical Affairs and will be responsible for building and leading the USMA team for the solid… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned US RA strategist...ways of working across the Alliance within US regulatory affairs and will work closely with the US Regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... Qualifications7 or More Years in the pharmaceutical industry4 or More Years in regulatory affairs , NDA, sNDA, BLA filing to FDA Travel Ability to travel up to 30%… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... Years in the pharmaceutical industry preferred1 or More Years in regulatory affairs requiredExperience in (s)NDA/BLA filing to FDA preferred Travel Ability to travel… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... the product's lifecycle and across different indications. Represent Global Regulatory Affairs on the GPT (Global Project Team), Daiichi Sankyo governance processes,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience with ex-US labeling… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... variety of processes and projects for all of Legal & Corporate Affairs (LCA) including but not limited to: Vendor/Budget Management, Records Management, Litigation,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …understand the importance of, key internal constituents - Market Insights, Analytics, Medical Affairs , Sales Training, etc. Present to various internal ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... to ensure successful implementation of CDx and data collectionSupports Regulatory affairs in providing content and providing review of documents supporting CDx… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of documents supporting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …teams. Stakeholders include many functions within R&D and Commercial, and Medical Affairs . Responsibilities will be both process/capability development for ... leading change management initiatives preferred- Prior experience in clinical development, Medical Affairs , or Global Marketing preferred- Demonstrated success… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …alignment within (eg with translational research, clinical operations, clinical development, medical affairs CSPV and other internal groups) and outside ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Merck & Co. (Rahway, NJ)
- …commercial teams and cross divisional teams including R&D and manufacturing, medical affairs , Outcomes Research and AccessExecutional Excellence: Ability to ... commercial teams and cross divisional teams including R&D and manufacturing, medical affairs , Outcomes Research and AccessExecutional Excellence: Ability to… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director , Device Quality & Regulatory will play a pivotal leadership role within the organization, overseeing the quality assurance and ... regulatory CMC for complex medical devices, including auto-injectors and other innovative drug delivery...regulations and industry trends affecting device quality and regulatory affairs .Strategic ContributionsServe as a key member of the device… more
- Merck & Co. (Rahway, NJ)
- …Disease strategyLung Liaison on the organization's Pan-Tumor Early-Stage SquadCollaboration with Medical Affairs on strategic choices for advisory boards, ... Job DescriptionWe are currently recruiting for a Director Global Oncology Marketing for Lung cancer for...a complex set of stakeholders, including research and development, medical affairs , regulatory affairs , market… more
- Merck & Co. (Rahway, NJ)
- …commercial teams and cross divisional teams including R&D and manufacturing, medical affairs , Outcomes Research and AccessExecutional Excellence: Ability to ... expected to be a key growth driver for our company.These three Associate Director roles, Healthcare Provider (HCP) Strategy, Scientific Strategy, and Go to Market… more
