- Takeda Pharmaceuticals (Boston, MA)
- …preferred. + At least 5 years of experience in pharmaceutical industry within Drug Safety / Pharmacovigilance , with both investigational and marketed products. ... Company-wide patient safety expert for assigned pharmaceutical / biological / drug -device combined products, accountable for the safety strategy and major … more
- AbbVie (North Chicago, IL)
- …to support potential product related issues *Key medical quality interface with Pharmacovigilance & Patient Safety (PSEQ), Global Medical Affairs (GMA) and ... drug risk management and/or medical device/ combination product vigilance ( safety signal detection, data mining techniques, pharmacovigilance / device… more
- Boehringer Ingelheim (Ridgefield, CT)
- …programs reflect Boehringer Ingelheim's high regard for our employees. The Director , Global Regulatory Strategy Lead will provide strategic regulatory guidance and ... represent Global Regulatory Affairs (GRA) on the Evidence Team. The Director , Global Regulatory Strategy Lead will craft comprehensive, well-thought through… more
- Merck (Rahway, NJ)
- **Job Description** Director , Devices & Combination Products Complaints QA We are seeking a highly motivated and experienced Director of Combination Products ... products with a focus on auto-injectors, pre-filled syringes and other innovative drug delivery systems. The ideal candidate will have a strong background and… more
- AbbVie (Mettawa, IL)
- …communications, training, and clinical value proposition) and safeguarding patient safety (risk minimization activities and safety surveillance activities). ... the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements + Participates… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Senior Clinical Research Director , Ophthalmology **Location** : Cambridge, MA Morristown, NJ **About the Job** Are you ready to shape the future of ... medicine? The race is on to speed up drug discovery and development to find answers for patients...helping our teams accelerate progress. The Senior Clinical Research Director (CRD) is an **expert clinical lead for one… more
- BeOne Medicines (San Mateo, CA)
- …in clinical development, program leadership, biometrics, clinical operations, safety / pharmacovigilance , regulatory, molecular diagnostics, and translational ... The Executive Director , Clinical I/O Development will support BeOne Medicine's...2 studies in late development) + Seamless transition of drug candidates from research to early clinical development +… more
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- …+ Ensuring alignment amongst relevant functional groups + Review of report from Drug Safety / Pharmacovigilance , as needed + Preparing for and participating ... depression in adults as monotherapy and as adjunctive therapy. The Senior Director , Medical Affairs supports the Medical Affairs department in the development and… more
- BeOne Medicines (San Mateo, CA)
- …in clinical development, program leadership, biometrics, clinical operations, safety / pharmacovigilance , regulatory, molecular diagnostics, and translational ... The Director , Clinical Development, Solid Tumors will support BeOne...applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports + Clinical sections of Health Authority… more
- BeOne Medicines (San Mateo, CA)
- …in clinical development, program leadership, biometrics, clinical operations, safety / pharmacovigilance , regulatory, molecular diagnostics, and translational ... The Senior Director , Clinical Development, Solid Tumors will support BeOne...applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports + Clinical sections of Health Authority… more