- Takeda Pharmaceuticals (Lexington, MA)
- …of my knowledge. **Job Description** **About the role:** Join Takeda as a Senior Manager, US Medical Information and Review where you will deliver high-quality, ... information / clinical expertise for assigned products to internal (Medical Affairs strategy teams, Therapeutic Area Units within R&D, commercial Brand teams)… more
- Highmark Health (Boston, MA)
- …acts within the parameters of federal and state laws, regulations, and regulatory guidance. The incumbent is also responsible for the administration, interpretation, ... and intake protocols, monitoring and implementation of new or changing regulatory requirements, risk assessment and audit execution, risk treatment plans, policy… more
- Fujifilm (Boston, MA)
- …business objectives. + Advise, counsel and report to Division General Counsel and senior business management on general legal and regulatory risks affecting the ... **Position Overview** We are hiring a Senior Counsel to be an integral part of...Description** **Responsibilities** + Manage and support the day-to-day legal affairs of assigned Medical Device businesses or operating divisions,… more
- Merck (Boston, MA)
- …scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations) + ... Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research throughout… more
- Amentum (Boston, MA)
- …Device, BioTech, etc.), is essential. This often includes experience with regulatory affairs , quality management systems (QMS), and project/program management. ... Senior Director of Operations, Integrated Facility Management, with...as necessary and desirable, to operational managers and other staff . + Ensures that the responsibilities, authorities and accountability… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …appropriate. + Collaborate with cross-functional teams including R&D, Quality Assurance, Regulatory Affairs , and Operations to align strategies and optimize ... **Position Overview:** The Senior Director, MSAT Biologics provides strategic and technical...validation lifecycle (PPQ, CPV, etc.) ensuring compliance with global regulatory standards. + Establish and oversee robust Continued Process… more
- Amgen (Cambridge, MA)
- …closely with cross-functional teams, including R&D, manufacturing, quality assurance, and regulatory affairs , to ensure alignment and successful design transfer. ... Join us and transform the lives of patients while transforming your career. Senior Engineer, Design Transfer Specialist **What you will do** Let's do this. Let's… more
- Highmark Health (Boston, MA)
- …position serves as a key liaison between Claims Operations, Customer Service, Regulatory Affairs , IT, Legal and other departments, proactively identifying, ... assessing, and mitigating compliance risks. The Analyst will monitor regulatory changes, interpret their impact on operational processes, and implement effective… more
- Beth Israel Lahey Health (Plymouth, MA)
- …latest trends in field of expertise especially related to health care quality, regulatory affairs , organizational behavior and leadership + Performs all duties ... affairs related to health care delivery and medical staff management of patient care while providing a visible,...leadership within the organization by working collaboratively with other senior leaders and medical staff leaders to… more
- Takeda Pharmaceuticals (Lexington, MA)
- …program management experienced in leading cross-functional clinical programs within Medical Affairs , Clinical Research, Regulatory , CMC or other drug development ... phases of development with significant experience within related functions (eg, Medical Affairs , Clinical Operations, Regulatory , CMC, Marketing). + Minimum of 5… more