- Otsuka America Pharmaceutical Inc. (Boston, MA)
- The Associate Director of Regulatory Intelligence leads the collection and dissemination of regulatory intelligence and collaborates with SMEs to interpret the ... EMA, PMDA, ICH, etc. + General knowledge of global regulations for pharmacovigilance reporting for approved and investigational products. + Confirm list of upcoming… more
- Takeda Pharmaceuticals (Boston, MA)
- …inspire you and empower you to shine? Join us as a Executive Medical Director , Oncology Clinical Sciences in our Cambridge office. At Takeda, we are transforming the ... compounds. + Reviews and assesses overall safety information in conjunction with Pharmacovigilance and Medical Monitor of record for assigned compounds. + Oversees… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …company that will inspire you and empower you to shine? Join us as Director , Quantitative Clinical Pharmacology (QCP) Lead in our Cambridge, MA office. Our Data and ... statistics, programming, outcomes research and epidemiology, patient safety & pharmacovigilance , digital strategy, library sciences, and data architecture/governance) bring… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** US Medical Director - Neuromuscular and Neurodegenerative Diseases **Location:** Cambridge, MA / Morristown, NJ **About the Job** Sanofi focuses on ... product strategy + Work with Clinical, Global Medical/Scientific Communications, Pharmacovigilance , and Statistics teams on post-hoc analyses and benefit/risk… more
- Pfizer (Boston, MA)
- …alternate site clinic negotiations, and formulary inclusion for biosimilars. + Pharmacovigilance and post-market safety monitoring. + Preferred: + Oncology and/or ... Immunology & Inflammation therapeutic area expertise. + Proven success engaging Academic Medical Centers, Integrated Delivery Networks (IDNs), and large group practice community accounts. + Strong understanding of evolving healthcare landscape in US, including… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …Quality/Compliance experience. + Advanced knowledge of clinical research (GCP), pharmacovigilance (GVP) and medical throughout R&D and commercialization, and ... relevant regulations. + Preferably with experience in strategic roles involving quality systems and clinical portfolio oversight, large-scale audit programs, regulatory inspection management, investigation and remediation activities on a global level and… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …programming, outcomes research and epidemiology, patient safety & pharmacovigilance , digital strategy, library sciences and data architecture/governance) bring ... their expertise to our global program teams and reimagine our disciplines. They work with novel data streams, including real-world data and digital tools, and apply advanced analytics including artificial intelligence and automation. As part of DSI, the… more