- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director /Principal Medical Writer **Location:** Cambridge, MA Morristown, NJ **About the Job** Are you ready to shape the future of ... who has an extensive experience with the preparation of clinical documents and regulatory dossiers and has demonstrated leadership skills as submission lead. As an… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Director Bioanalytics Characterization **Location:** Framingham, MA **About the Job** Are you ready to shape the future of medicine? The race is on to ... in helping our teams accelerate progress. Join our Bioanalytics Mammalian team as Director of Bioanalytics Characterization and you'll be able to play a key role… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …Drug Safety, Clinical Sciences, Outcomes, Digital Health, Pharmaceutical Sciences/Device, and Global Regulatory Affairs. + Advanced knowledge of regulatory ... you and empower you to shine? Join us as Director , Quantitative Clinical Pharmacology (QCP) Lead in our Cambridge,... interactions. + Represents Clinical Pharmacology in meetings with global or regional regulatory agencies and be… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …external regulatory interactions. + Represents Clinical Pharmacology in meetings with global or regional regulatory agencies and be responsible for clinical ... and empower you to shine? Join us as a Director , Quantitative Clinical Pharmacology Lead in our Cambridge, MA...Experience in representing the QCP function in interactions with global or regional regulatory agencies at significant… more
- Sumitomo Pharma (Boston, MA)
- Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma ... seeking a dynamic, highly motivated, and experienced individual for the position of ** Director , Patient & HUB Operations, Rare Disease** . The Director , Patient… more
- Bristol Myers Squibb (Cambridge, MA)
- …development including analytical validation, clinical development, manufacturing, US and global regulatory submission, and commercialization of diagnostics. ... medicine and R&D. We have an exciting opportunity for a Senior Director to join the Precision Medicine, Bioanalytical and Translational Sciences organization, where… more
- Bayer (Cambridge, MA)
- … packages, regulatory exchanges and data therein; + Understanding of global pharmaceutical regulatory requirements, data standards (eg, IDMP, XEVMPD, SPOR), ... to make a real difference, there's only one choice.** ** Director R&D Reg Data Mgmt Expert DSAI** **YOUR TASKS...management with an initial specific focus on product and regulatory data. This role has broad accountabilities for the… more
- Grifols Shared Services North America, Inc (Fall River, MA)
- …Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being ... more than 110 countries and regions. The primary responsibility of the MSL Field Director is the management, performance, and coaching of a team of MSL direct… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Ensure clinical operations deliverables and work product are compliant with global regulatory and compliance requirements for clinical research, including but ... your future at Takeda. Join us as the Executive Director of Clinical Operations reporting to the Head of...complex global studies. + Expert knowledge of global regulatory and compliance requirements for clinical… more
- Hologic (Marlborough, MA)
- …Audit Program, ensuring compliance with FDA regulations, ISO standards, and other global regulatory requirements. If you thrive in a fast-paced, collaborative ... Director , Internal Audit Marlborough, MA, United States Are...standards (eg, ISO 13485:2016, ISO 14971), MDSAP, and other global regulatory requirements. + Expertise in Quality… more