- J&J Family of Companies (Titusville, NJ)
- …interactions also includes individuals from project management, TA strategy, global regulatory affairs , finance, legal, quality assurance, quality monitoring & ... health, global clinical operations, health economics, epidemiology, global medical affairs and other scientific and business related...emerging from the Team and its affiliates + Assists Regulatory Affairs in the development of drug/device… more
- Takeda Pharmaceuticals (Boston, MA)
- … regulatory labeling landscape. + Understanding of other relevant regional regulatory nuances and requirements. + Understanding of scientific principles and ... bring life-changing therapies to patients worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the development… more
- Medexus Pharma (Pittsburgh, PA)
- …join our Medical Affairs team. The MSL will serve as a scientific expert and trusted advisor, engaging with Key Opinion Leaders (KOLs), healthcare providers ... guidance on publications and congress presentations. + Create and deliver medical affairs content: scientific slide decks, standard response letters (SRLs),… more
- Sanofi Group (Morristown, NJ)
- …Development Plan (in close cooperation with other members of the team, particularly Regulatory Affairs and Health Economics); adjusts and updates the strategy ... **Job Title:** Senior Clinical Research Director **Location:** Morristown, NJ Cambridge,...tasks. We are looking for individuals with drive, curiosity, scientific mindset, and appreciation of teamwork with a diverse… more
- Boehringer Ingelheim (Ridgefield, CT)
- …assigned assets, lead the Regulatory Excellence Team (RET) and represent Global Regulatory Affairs (GRA) on the Evidence Team. The Director, Global ... molecule) + Further degrees/certifications: Specialized Pharmacist or Master of Drug Regulatory Affairs , RAC certification Technical expertise: + In-depth… more
- Takeda Pharmaceuticals (Boston, MA)
- …in regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively ... on patients worldwide. Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of...resource gaps for assigned project(s). + May present to senior management as requested. + Participate with influence in… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ... Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor. **Job Category** Ext. Affairs , Regulatory , & Communications **Job Type** Full-Time more
- Gilead Sciences, Inc. (Foster City, CA)
- …A summer internship is available in the CMC (chemistry, manufacturing and controls) Regulatory Affairs Department at the Foster City, CA, campus of Gilead ... be enrolled in an Undergraduate/Graduate Program with a focus in chemistry, biology, regulatory affairs or closely related subject. The summer intern will… more
- Merck (Boston, MA)
- …innovative medicines, and we work with cross-functional colleagues in Global Medical and Scientific Affairs and Global Policy to ensure timely and equitable ... process (mainly Phase 2-3) including study design, medical monitoring, and medical/ scientific interpretation of study analyses, regulatory reporting, and… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …but not limited to Translational Research & Biomarkers, Clinical Management, Global Regulatory Affairs , Global Clinical Development (late phase), Data & ... to her/him on the early development CNS portfolio and Early Development Teams. This Senior Director is a strategic scientific and clinical leader accountable for… more