- GE HealthCare (MA)
- …Pharmacovigilance Physician to lead and support drug safety activities across the ** United States and Canada** , with additional responsibilities in **global ... Strong knowledge of global pharmacovigilance regulations and guidelines, especially US FDA + Ability to work effectively...those who are legally authorized to work in the United States for this opening. Any offer… more
- Sanofi Group (Cambridge, MA)
- …are conducted in compliance with current regulations, laws, and guidance from FDA , EMeA, and CHMP, as well as with Sanofi's policies and procedures. **About ... **Job title:** Global Program Head , Neurology **Location:** Cambridge, MA **About the job**...they are required to perform. Including accountability and maintaining compliance training for direct reports + Works cross functionally… more
- Takeda Pharmaceuticals (Lexington, MA)
- …quality systems for medical device and digital health technologies, ensuring compliance with international regulatory requirements and Takeda Global procedures. + ... (IVDs), and Software as a Medical Device (SaMD), ensuring compliance with global quality standards. + Define and lead... with applicable medical device and software regulations (eg, FDA 21 CFR Part 820, ISO 13485, ISO 14971,… more
- Bristol Myers Squibb (Devens, MA)
- **Working with Us ** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is ... both at work and in their personal lives. Read more: careers.bms.com/working-with- us . **Position Summary** This position is responsible for providing investigation… more
- Parexel (Boston, MA)
- …Manager (CQOM), in collaboration with the Clinical Quality Operations Lead (CQOL) and Head of Clinical Quality Operations (CQO), is responsible for the execution of ... trends and provide relevant feedback to the CQOL and Head of CQO as appropriate within a specific therapy...Contact (POC) for a specific area of regulations (eg FDA , EMA, NMPA, etc.). As such, the Clinical Operations… more
- Takeda Pharmaceuticals (Boston, MA)
- …to the best of my knowledge. **Job Description** **_Objective / Purpose:_** The Head of Design & Delivery, PharmSci will lead the global digital product strategy ... + Ensure all products are developed and maintained in compliance with global regulations (eg, GxP, 21 CFR Part...with global regulations (eg, GxP, 21 CFR Part 11, FDA ) and Takeda's quality and risk management standards. +… more
- Sanofi Group (Cambridge, MA)
- …MA / Morristown, NJ **About the Job** This role reports into the Global Medical Head of Hemophilia; that is part of the Global Rare Disease Medical Team. Our Medical ... Supports regulatory interactions and respond to request from the global regulatory agencies ( FDA , EMA and other agencies) as required and appropriate + He/she will… more
- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration ( US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... we need passionate, driven people like you to help us get there. Our cutting-edge healthcare solutions span diagnostic...electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world… more
- Editas Medicine (Cambridge, MA)
- …of gene editing, and push the boundaries of what's possible in medicine, come join us and become an Editor! Decoding The Role: Editas Medicine is seeking a highly ... In this leadership role, you will serve as the Head of Toxicology within Editas and be responsible for...authorities, including the authoring of nonclinical safety sections of US and international regulatory applications + Manage CRO relationships… more