- 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
- Olympus Corporation of the Americas (Westborough, MA)
- …by applicable federal, state or local law. Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) ... supports business objectives through: proactive monitoring and application of global regulatory requirements within the regional QMS; leading the governance of the… more
- J&J Family of Companies (Cambridge, MA)
- …Titusville, NJ, or San Diego, CA. May require approximately 25% domestic and international travel. At Johnson & Johnson, we believe health is everything. Our ... closely with Neuroscience Therapeutic Area, Clinical Development, Quantitative Sciences, Regulatory and Patient Reported Outcomes as well as external collaborators… more
- Sumitomo Pharma (Marlborough, MA)
- …ensure system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. + ... and ensure final transfer of TMF is sufficient to support any potential regulatory filings. + Champion best practices for building and maintaining TMF health.… more
- Beth Israel Lahey Health (Boston, MA)
- …an office in the Sponsored Programs Administration Division under Research and Academic Affairs whose mission is to facilitate the conduct of research at Beth Israel ... status data into tracking system. (essential)** **Identifies and mitigates regulatory compliance, legal, intellectual property, and other risks. (essential)**… 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 ... Value and Evidence, Clinical development, Global Scientific Communications, Commercial, International teams and external partners to ensure alignment and integration… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …teams as needed. + Work closely with cross-functional teams, including commercial, regulatory , legal, R&D, and medical affairs , to ensure cohesive communication ... or consultancy, with expertise in corporate, product, executive, and/or international communications. + Experience supporting or managing therapeutic brands, as… more
- Takeda Pharmaceuticals (Boston, MA)
- …development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency ... external compounds (alliances and in-licensing opportunities) + Primary interface with Medical Affairs team for strategy and to support of product commercial efforts… more
- Sanofi Group (Cambridge, MA)
- …the evolving policy landscape. + Anticipate and interpret legislative, regulatory , and market trends; drive forward-thinking, cross-functional solutions to complex ... workgroups. + Draft and oversee the submission of formal comment letters, regulatory responses, and testimony. **Internal Advisory & Business Partnership** + Provide… more
- Candela Corporation (Marlborough, MA)
- …improvement actions related feedback. . Jointly accountable with Quality System (QS) and Regulatory Affairs (RA) Leadership for ensuring the QS is effectively ... established/maintained according to company policies/procedures and applicable local/state/federal/ international requirements. . Actively support Quality and Sustaining Engineering… more