- Takeda Pharmaceuticals (Boston, MA)
- …**OBJECTIVES:** + Provides oversight from a clinical research and pharmacovigilance perspective of regulated post-authorization activities in the commercial business ... affiliate and enables them to deliver their clinical research and pharmacovigilance -related regulated activities with high compliance and agility. + Establish and… more
- Takeda Pharmaceuticals (Boston, MA)
- …to the best of my knowledge. **Job Description** **About the role:** The Associate Director, Clinical & Quality Process Compliance is responsible for ensuring the ... compliance teams for regulations impacting Clinical, Safety and Clinical Pharmacovigilance Medical Quality (CPMQ) processes and procedures and determined by… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director, Audit Readiness, Patient Support Services, OPIE **Location:** Morristown, NJ Cambridge, MA **About the Job** Join the team ... bring hope to patients with some of the highest unmet needs. **The Associate Director, Audit Readiness** will report to the **Sr. Director, Patient Support Services… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director, Rare Blood Disorders, Patient Services **Location:** Cambridge, MA **About the Job** Join the team transforming care for people ... bring hope to patients with some of the highest unmet needs. The Associate Director, Sutimlimab Patient Solutions will report into the Director of Patient Services… more
- Sumitomo Pharma (Boston, MA)
- …a dynamic, highly motivated, and experienced individual for the position of ** Associate ** **Medical Director, Clinical Development - Oncology** . The associate ... for INDs, NDAs, and other related documents. + Partner with Drug Safety & Pharmacovigilance to assess the safety profile of compounds. + Maintain a high level of… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …inspire you and empower you to shine? Join us as an Associate Medical Director, Clinical Science, Neuroscience- Pulmonologist/Neurologist in our Cambridge, MA ... a vital contributor to our inspiring, bold mission. **POSITION OBJECTIVES:** The Associate Medical Director leads and drives strategy for the overall global… more
- Takeda Pharmaceuticals (Boston, MA)
- …to the best of my knowledge. **Job Description** **ABOUT THE ROLE** The Associate Director, GCP Audit & Compliance provides strategic quality oversight to clinical, ... medical, and pharmacovigilance suppliers across Takeda's global network. You will lead the risk-based supplier audit program, drive compliance insights, and partner… more
- 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
- Merck (Boston, MA)
- …interacting with health agencies (eg FDA); understand key elements in pharmacovigilance , drug safety monitoring, signal detection and processing of adverse reports; ... (c) **Global Medical/Scientific Affairs:** Exposure to the management of a product asset prior to, during and after the launch phase (US and Global) including caveats on drug promotion. After a successful first year, the Physician Scientist will be equipped to… more
- Takeda Pharmaceuticals (Boston, MA)
- …Quantitative Sciences, Programming, Global Evidence Outcomes, Patient Safety & Pharmacovigilance , and Strategic Operations The department integrates data science, ... analytics, and quantitative methods to enhance efficiency and precision throughout the drug discovery and development lifecycle. It leverages cutting-edge technology, machine learning, AI, and statistical methods to analyze complex datasets, generate… more