- Sanofi Group (Cambridge, MA)
- **Job Title:** Lead , Regulatory Data **Location** : Cambridge, MA, Morristown, NJ **About the Job** Are you ready to shape the future of medicine? The race ... Lead role is the business owner for the regulatory data migration at an operational level...**Main Responsibilities:** Primary areas of responsibility include: + The Lead , Regulatory Data role provides… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Global Regulatory Lead **Location** : Morristown, NJ, Cambridge, MA **About the Job** Are you ready to shape the future of medicine? The race is ... Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs Lead (GRL) is the fully accountable decision maker for the… more
- Sanofi Group (Cambridge, MA)
- … Affairs (GRA) Device Head, Specialty Care Device and Combination Products will lead a team responsible for device regulatory activities associated with Sanofi's ... was possible. Ready to get started? **Main Responsibilities:** + Lead , supervise and coach a team of regulatory...project strategies + Ability to synthesize and critically analyze data from multiple sources + Ability to travel internationally… more
- Fresenius Medical Center (Waltham, MA)
- …regulatory strategy and market access plans. + Utilize market intelligence and regulatory data to optimize product lifecycle management, regulatory ... delivery of high-quality pharmaceutical products. **PRINCIPAL DUTIES AND RESPONSIBILITIES:** + ** Regulatory Strategy Leadership:** + Lead the development of… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …for cell therapy and stem cell transplant. In this position you will build and lead a cell medicine regulatory affairs team and provide regulatory leadership ... the formulation of briefing documents focused on strategic and scientific content. + Build, lead and mentor the regulatory team and provide project teams with… more
- Tecomet (Manchester, NH)
- …practices remain compliant; + Oversee supplier qualification, audits, performance monitoring, and regulatory compliance of supply chain partners; + Lead and ... **POSITION SUMMARY:** The Quality Assurance & Regulatory Affairs Manager oversees the quality management system...and documentation; + Proficiency with Microsoft Office suite and data analysis tools; + Familiarity with quality management and… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …and Local Affiliates (LOCs) to design, scale, and operationalize prioritized Analytics and Data Science products. Lead AI and Analytics experiments, act as a ... regulatory requirements and compliance. + Strong proficiency in data -driven decision-making and analytics platforms. + Deep understanding of Data… more
- Wolters Kluwer (Waltham, MA)
- …the development of new datasets, delivered through web services architecture, with accompanying data visualization tools. + ** Lead Research & Market Analysis** : ... As a ** Lead Product Manager** on the Wolters Kluwer Health...and Consulting organizations. This role focuses on developing innovative data and analytics-driven products that address the complex needs… more
- Bristol Myers Squibb (Cambridge, MA)
- …lives. Read more: careers.bms.com/working-with-us . The Sr. Director, HRBP for Global Regulatory Strategy and Worldwide Patient Safety in Drug Development, plays a ... Services leaders for effective global deployment of People activities. + Analyzes key data and trends to drive organizational effectiveness and the development of a… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …my employment application is true to the best of my knowledge. **Job Description** ** Lead Counsel, SBU & R&D DD&T ( Data , digital and technologies) Contracts** ... issues and technology-related matters, including software licensing, intellectual property, data privacy, cybersecurity, and compliance, and assist in developing… more
- Sanofi Group (Cambridge, MA)
- …Contribute in the clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIP **Clinical expertise, scientific data evaluation and ... **Job Title:** Clinical Lead , I&I **Location** : Cambridge, MA or Morristown,...and cluster feasibility, medical review and validation of clinical data , study risk assessment + Support and input preparation… more
- Sanofi Group (Cambridge, MA)
- …thought was possible. Ready to get started? **Main Responsibilities:** + Serve as Device Regulatory Lead on assigned project teams (early phase, late stage and ... **Job Title:** GRA Device Lead **Location** : Morristown, NJ, Cambridge, MA, Framingham,...of products. The team is part of the Global Regulatory Affairs, Regulatory CMC and Device Department… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …empower you to shine? Join us as a Director, Quantitative Clinical Pharmacology Lead in our Cambridge, MA office. Takeda is a global, values-based, R&D-driven, top ... commitment to patients, our people, and the planet. Our Data and Quantitative Sciences group (DQS) is made up...The QCP role works in partnership with the pharmacometrics lead to drive a MIDD path within each At… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Digital Biomarker Operational Lead **Location** : Cambridge, MA, Morristown, NJ **About the Job** Are you ready to shape the future of medicine? The ... on establishing and executing digital biomarker programs that generate health-related data through digital health technologies (DHTs), provide valuable insights into… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Health Value Translation Lead **Location** : Morristown, NJ, Cambridge, MA **About the Job** Are you ready to shape the future of medicine? The race ... teams accelerate progress. Within Sanofi R&D, the Health Value Translation (HVT) Lead sits within Patient Informed Development and Health Value Translation function.… more
- Bristol Myers Squibb (Cambridge, MA)
- …to regulatory queries for the TM group + Participate/present data at scientific advisory boards to support drug programs/projects + Communicates regularly ... assigned programs. Key responsibilities of this role are to act as a lead scientist to deliver and implement biomarker strategies for clinical programs, develop… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Digital Device Quality Engineering Lead **Location** : Cambridge, MA **About the Job** At Sanofi, we're committed to providing the next-gen healthcare ... that patients and customers need. It's about harnessing data insights and leveraging AI responsibly to search deeper...Global Digital Team as a Digital Device Quality Engineering Lead . You will be responsible for the quality assurance… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Channel Launch and Execution Lead **Location:** Morristown, NJ, Cambridge, MA **About the Job** The Channel Launch & Execution Lead will serve as ... around the world. **Main Responsibilities:** **Launch Distribution Strategy Development** + Lead the end-to-end design and implementation of trade and distribution… more
- Bristol Myers Squibb (Cambridge, MA)
- …Read more: careers.bms.com/working-with-us . **Position Summary** The Clinical Development Lead sits within Clinical Development, which is a global organization ... trials. + CDLs are matrix leaders and managers who lead , develop, motivate and achieve results through teams; demonstrate...with target label indications and are designed to meet regulatory , quality, medical, and access goals + Serves as… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …clinical development, and post-market activities. Secure implementation and delivery of data and interpretation. **ACCOUNTABILITIES** + Partner with GI2 DDU research ... Translational Research to discover and validate targeted pathways based on human data and define candidate biomarkers for mechanisms of action and drug response.… more