- GRAIL (Boston, MA)
- …provide direction to regulatory staff and, when required, participate in senior management meetings as a delegate. The role fosters a work culture aligned with ... when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders...**Experience** + Minimum of 10 years of experience in regulatory , development, clinical affairs, quality, or program management… more
- Commonwealth Care Alliance (Boston, MA)
- …they relate to provider satisfaction and network performance. - Experience with change management and process improvement methodologies. - Knowledge of ... key healthcare providers, optimizing network performance, and ensuring compliance with regulatory standards. The Director drives initiatives that enhance… more
- Pfizer (Cambridge, MA)
- …and solid understanding of related disciplines, eg, Clinical Operations, Data Management , Safety, Biostatistics, Regulatory , Study Management , Pre-Clinical, ... study reports (CSRs), investigator brochures, statistical analysis plans, and regulatory documents. Foster a transparent environment that builds strong partnerships… more
- Curia (Boston, MA)
- …mitigation activities for equipment. + Provide technical support to clients for regulatory filings, change control and quality impact assessments. + Develops ... Director , Analytical Development in Hopkinton, MA Build your...methods using the ICH, FDA and EMA guidelines and regulatory requirements. + Multiple years of management … more
- United Site Services (Westborough, MA)
- …of strategic oversight and hands-on involvement. + Implement structured governance, release management , and change management for all enterprise ... project and event success. Our deep industry expertise, excellence in process management , and dedication to corporate responsibility are pillars of our value… more
- Olympus Corporation of the Americas (Westborough, MA)
- …https://www.olympusamerica.com/careers . **Job Description** Oversee all aspects of the Quality Management System (QMS) across the Americas. Ensures the QMS design ... supports business objectives through: proactive monitoring and application of global regulatory requirements within the regional QMS; leading the governance of the… more
- Parexel (Boston, MA)
- …close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and ... commitment in the individual studies. **Key Accountabilities** : **Site Management Responsibilities** + Contributes to the selection of potential investigators.… more
- Parexel (Boston, MA)
- …close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and ... include additional tasks associated with LSAD. **Key Accountabilities:** **Site Management Responsibilities** + Contributes to the selection of potential… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …implement processes for the review of Promotional and Disease awareness materials. + Change Management - ability to identify, advocate and implement change ... in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant management of regulatory ... you will contribute:** + Lead site-specific post-approval change management activities, including record evaluations and regulatory submissions (considering… more
