- Cardinal Health (Mansfield, MA)
- Cardinal Health is seeking a Principal Regulatory Affairs Specialist to support the Medical Solutions Regulatory Affairs team. The selected candidate ... + May act as a mentor to less experienced colleagues **_Responsibilities_** + The Principal Regulatory Affairs Specialist is responsible for the support of… more
- Philips (Cambridge, MA)
- The Principal Regulatory Affairs Specialist will develop and execute the regulatory strategy for new product development, design changes, and field ... if:** + You've acquired a minimum of 7+ years' experience in Regulatory Affairs /Strategy within FDA regulated Medical Device environments. + You have proven… more
- Cytel (Cambridge, MA)
- **Who Are You?** An experienced Principal Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you ... will lead one or multiple medical affairs projects. You are excited and enthusiastic, motivate your...part of this new program. **Position Overview:** As a Principal Biostatistician, you are responsible for statistical activities in… more
- Bristol Myers Squibb (Devens, MA)
- …Stability, Analytical Development, Process Development, Manufacturing Sciences and Technologies, Regulatory Affairs , and other Cell Therapy Development ... QA, QC, analytical and process development, manufacturing sciences and technology, and regulatory affairs functions. + Supports the overall product quality… more
- Sanofi Group (Cambridge, MA)
- …data submissions. + Recognized authority in business process optimization in regulatory affairs . + Expert understanding of capability-based planning, agile ... **Job Title:** Principal Capability Professional for Registration Tracking xEVMPD **Location**...with enterprise impact, serve as a strategic bridge between regulatory SMEs, business process owners, and digital product teams,… more
- Prime Therapeutics (Boston, MA)
- … Affairs to understand, interpret and effectively communicate complex regulatory policies and contract obligations relevant to the segment, ensuring alignment ... of pharmacy with us. **Job Posting Title** Health Individual Marketplace Strategies Principal - Remote **Job Description** The Principal of Health Individual… more
- Edwards Lifesciences (Boston, MA)
- …at the heart of everything we do. As part of our Medical Affairs team, you'll foster internal and external collaboration to generate and disseminate evidence-based ... healthier lives. Join us and be part of our inspiring journey. The Principal Biostatistician will represent the Biostatistics department on all aspects of the… more
- Merck (Boston, MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... **Job Description** The Senior Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research activities… more
- Merck (Boston, MA)
- …on project teams, working closely with biomarker scientists, clinical and medical leads, regulatory affairs , clinical operations, and CMC teams. + **Reporting & ... implementation of novel PET tracers in oncology studies, guide regulatory submissions, and act as the PET imaging expert...robust study design and high-quality PET data collection. + ** Regulatory support** : Familiarity with regulatory and… more
- Merck (Boston, MA)
- …+ Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... **Job Description** The **Clinical Director ( Principal Scientist)** has primary responsibility for the strategic planning and directing clinical research activities… more