- ConvaTec (Lexington, MA)
- …compliance with all relevant regulations including ICH GCP guidelines, local regulatory requirements, and Convatec's policies and SOPs. **Key Responsibilities:** + ... input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as… more
- Fujifilm (Boston, MA)
- …**Job Description** **Responsibilities** + Manage and support the day-to-day legal affairs of assigned Medical Device businesses or operating divisions, under the ... Division General Counsel and senior business management on general legal and regulatory risks affecting the Medical Device businesses, including with respect to… more
- Sanofi Group (Waltham, MA)
- …is accountable for all statistical aspects of clinical development/medical affairs plans, studies and submissions activities (when applicable), including quality, ... relevance to external stakeholders (eg regulatory authorities, medical journals), and scientific validity. We are...+ Contribute with project team members (ie: clinical, pharmacovigilance, regulatory , ) to gain Health Authorities acceptance of the… 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 ... the clinical development process, ranging from clinical trial designs to regulatory submissions while applying scientific rigor to statistical methods and… more
- State of Massachusetts (Boston, MA)
- …of Insurance ("DOI"), an Agency within the Office of Consumer Affairs and Business Regulation, administers the Commonwealth's insurance consumer protection laws ... prescription drug manufacturers, and of their disclosure practices in relation to regulatory standards and statutory requirements. * Manage the review of pharmacy… more
- Rhythm Pharmaceuticals (Boston, MA)
- …Associate Director, Scientific Communications as part of the North America Medical Affairs team to lead the strategic planning and execution of scientific ... all scientific communications adhere to industry codes, ethical standards, and regulatory requirements. Qualifications and Skills + Advanced degree (PhD, PharmD or… more
- State of Massachusetts (Boston, MA)
- …of Occupational Licensure (DOL), an agency within the Office of Consumer Affairs and Business Regulation (OCABR), protects consumers by making sure the professionals ... Commissioner for Boards, Operations, and Policy on Agency procurements. *External Affairs * * Coordinate with senior staff on legislation, policy initiatives,… more
- Dana-Farber Cancer Institute (Boston, MA)
- …Credentialing** + Provide executive oversight of the Office of Medical Affairs and Professional Credentialing. + Ensure medical staff credentialing, enrollment, and ... + Support medical staff committee infrastructure and maintenance of bylaws and regulatory standards. **Board and Faculty Communications** + Lead the development of… more
- Edwards Lifesciences (Boston, MA)
- …and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to ... with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize… more
- Boston University (Boston, MA)
- …entry-level employees. -Collaborates with colleagues in Budget & Planning, Financial Affairs , and other key stakeholders across the university to conduct scenario ... in a university environment. + Deep understanding of GAAP and other regulatory standards required for the higher education industry. + Experience creating… more