- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA is ... strategy and quality plan closely aligned with the Global Oncology Medical Affairs (GOMA), Oncology Business Unit (OBU) and Specialty Business Unit (SBU) Medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Sr. Director , Data Quality and Integrity (Global R&D & PV QA) ensures high ... process improvements. Collaborating with the Global QMS eCompliance team, the director oversees QA plans, promotes data governance, and engages stakeholders to… 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 ... regulatory reporting, publication, and presentation at national and international meeting.-They will lead cross-functional product development teams that oversee… more
- Genmab (NJ)
- …Management, Clinical Operations, Medical, Biomarker Management, Biostatistics, Medical Writing, and Regulatory Affairs to ensure alignment of data strategy with ... and protocol deviations and is a key driver for inspection readiness, regulatory compliance, and successful data submissions.The Associate Director will lead… more
- Merck & Co. (Rahway, NJ)
- …the guidance of a senior leader, a Senior Principal Scientist/Senior Director , has primary responsibility for developing value evidence strategies, and ... incumbent is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates and may… more
- Genmab (NJ)
- …with key stakeholders within Global Development Operations (GDO), Medical Affairs , Medical, and/or CROs, to enable expedited, predictive delivery for ... and tactical operational plans aligned to the commercial and regulatory objectives.Excellent stakeholder management, concise written communication, ability to… more
- Sanofi Group (Morristown, NJ)
- …best interests are represented **About You** This position requires a seasoned regulatory affairs professional with proven international experience from ... **Job Title:** Global Regulatory Affairs Device Head, Specialty Care...Device Head, Specialty Care Device and Combination Products (Sr. Director ) **Location** : Cambridge, MA or Morristown, NJ **About… more
- Bausch Health (Bridgewater, NJ)
- …itwhere your skills and values drive our collective progress and impact. The Associate Director , Regulatory Affairs handles regulatory development and ... for assigned pharmaceutical products. + Coordinate/Liaise with BHC country-specific pharmaceutical Regulatory Affairs personnel for international submissions… more
- Bausch Health (Bridgewater, NJ)
- …creates itwhere your skills and values drive our collective progress and impact. The Director of Regulatory Affairs coordinates and oversees regulatory ... industry and regulatory experience + Knowledge of pharmaceutical brand industry regulatory affairs discipline throughout the product lifecycle + Knowledge of… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …value and real-world evidence, US and global commercial teams, market access, and regulatory affairs , to ensure integrated global strategies and cohesive medical ... disorders, we are seeking a skilled and experienced Medical Director of CNS Early Assets, Global Medical Affairs...or early development (phase 1) assets either within Medical Affairs , Regulatory Affairs , or Clinical… more
