- 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
- Olympus Corporation of the Americas (Westborough, MA)
- …deliverables from assigned projects as required by the SDLC and will support Regulatory Affairs ' efforts in creating submission materials for various ... Interacting with a diversity of disciplines such as R&D, Quality Engineering, Regulatory Affairs , etc. + Independent organizational and time management skills… 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 ... colleagues while developing and expanding your career. The Clinical Director ( Principal Scientist) has primary responsibility for the planning and directing of… 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
- Wolters Kluwer (Waltham, MA)
- …Principal SaMD TPM acts as a bridge between engineering, product, regulatory affairs , clinical, and quality assurance teams, facilitating strategic ... The ** Principal SaMD Technical Program Manager** plays a pivotal...**Cross-Functional Collaboration:** Act as a liaison between engineering, product, regulatory affairs , clinical, and QA teams to… more