- Sanofi Group (Cambridge, MA)
- …team and internal partners such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing. + Advance ... full clinical study protocol. + Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other regulations. + Review… more
- Takeda Pharmaceuticals (Boston, MA)
- …management system (PEARL) to generate trending tables that are utilized in regulatory filings described below; Verify GMP test data meets the established product ... release and shelf life; Represent the Analytical Controls group within Pharmaceutical Science CMC project teams, which requires excellent organizational and… more
- Sanofi Group (Cambridge, MA)
- …team and internal partners such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing + Advance ... full clinical study protocol + Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other regulations + Review… more
- Cognizant (Boston, MA)
- …with Pharmaceutical Industry - Strong experience in Clinical and Regulatory domains and systems like Veeva Vault QMS, DMS (Preferred) **Leadership and ... seamless integration across platforms. - Coordinate CSV activities to ensure compliance with regulatory standards. - Utilize ALM tools to manage and streamline… more
- Actalent (Framingham, MA)
- …seeking a detail-oriented and assertive Facility Maintenance Inspector to ensure compliance with Good Manufacturing Practices (GMP) across both laboratory and ... identifying potential risks, and ensuring that all infrastructure meets regulatory and operational standards. Responsibilities + Conduct routine and scheduled… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …seeking a highly skilled, self-motivated **Senior Validation Specialist- CSV** to ensure compliance of computerized systems with regulatory requirements in the ... validation activities to meet FDA and potentially other global regulatory standards such as 21 CFR Part 11, GAMP...and driving all CSV activities required to maintain quality compliance as per existing Policies and Procedures for RCM.… more
- Sanofi Group (Cambridge, MA)
- …of Privacy Officers. You will be part of Sanofi Privacy Leadership and US Compliance Leadership team We are an innovative global healthcare company with one purpose: ... Risk Owners. Through this council, you will drive the Risk Management and Compliance plan, reporting its status to Executive Leadership through established KPIs; +… more
- BioLife Plasma Services (Boston, MA)
- …exceptional customer service by assisting with production tasks while maintaining strict regulatory compliance and safety standards. + **Develop Leadership and ... program, gain hands-on experience in operational production, including financial, regulatory , administrative, marketing, quality, facilities, and people management. Gain… more
- Sanofi Group (Cambridge, MA)
- …Identifies ways to optimize program execution without compromise to patients or compliance . + Accountable to maintain the integrated Medical and Integrated Evidence ... PM function. **About you** **Experience:** + 10+ years experience in the pharmaceutical industry in expanding roles in Medical or related field, including experience… more
- Teledyne (Billerica, MA)
- …research, deepwater oil and gas exploration and production, medical imaging and pharmaceutical research. We are looking for individuals who thrive on making an ... experience in developing, maintaining, and tracking specification and requirements compliance matrix, risk identification and risk mitigation. + Experience in… more
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