- NTT DATA North America (Canton, MA)
- …governance frameworks, and compliance standards. Ensure alignment with GxP, FDA , EMA, and other regulatory requirements throughout project delivery + ... multiple SAP projects and workstreams, ensuring alignment with business objectives, regulatory requirements, and technology roadmaps. + The ideal candidate brings… more
- Cambrex High Point (Waltham, MA)
- … compliance . + Author and review analytical protocols, reports, and SOPs in compliance with GMP and regulatory expectations. + Conduct GMP testing and ... tests. + Strong working knowledge of GMP requirements, ICH guidelines, and regulatory expectations ( FDA , EMA). + Experience in quality control testing,… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …and related activities occur as outlined in the monitoring plan and in compliance with all related regulatory standards. Monitoring will be performed through ... environment. This position will be responsible for promoting a culture of monitoring compliance and regulatory awareness within DFCI and DF/HCC. **Remote work… more
- Charles River Laboratories (Shrewsbury, MA)
- …management, interpretation, and reporting of study data and assuring the regulatory compliance of these projects, as appropriate. Additional responsibilities ... in accordance with company standard operating procedures and industry regulatory guidelines. This position will serve as the primary...in the direction and execution of assigned studies in compliance with regulations as they apply to the conduct… more
- Sanofi Group (Framingham, MA)
- …Project Approvals (A) + Project < 5M (D) and Project > 5M (A) + Regulatory Compliance Strategies (A) + Process Improvement Initiatiaves (A) + Vendor Selection ... Performs strategic planning and development activities for site CQ, including compliance , capacity, timeline and direction. + Align department objectives with… more
- Sanofi Group (Cambridge, MA)
- …are conducted in compliance with current regulations, laws, and guidance from FDA , EMeA, and CHMP, as well as with Sanofi's policies and procedures. **About ... strategy, and the network of collaborators from preclinical research to operational, regulatory and commercial functions. Success in this role requires the ability… more
- Takeda Pharmaceuticals (Boston, MA)
- …and regulatory requirements, such as the federal Anti-Kickback Statute, OIG Compliance Program Guidance, FDA legislation, FCPA, UK Bribery Act, etc., as ... * Lead and conduct audits of Takeda's Non-GxP financial, operational, and compliance processes to evaluate Takeda's control environment within the Americas region… more
- Biomat USA, Inc. (Worcester, MA)
- …Implements Standard Operating Procedures (SOPs) for quality control and overall regulatory compliance . . Maintains oversight of center training program ... to the appropriate parties. . Directs and monitors processes and ensures center compliance with all applicable state, federal, and company-designated regulations.… more
- Baystate Health (Springfield, MA)
- …leaders in matters of corporate law, business transactions, financing, medical staff, regulatory compliance , health law, legal aspects of drug diversion ... by state/federal agencies such as Attorney General's office, federal FDA or DEA, HCFA, State Board of Registration in...Work Experience:** Corporate transactions, medical staff and health care regulatory compliance , advice related to the legal… more
- Sumitomo Pharma (Boston, MA)
- …encounters is considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and ... and manages Safety Charters + Handles Health Hazard Evaluations and Ad-Hoc Regulatory safety inquiries. + Represents PVRM on post-marketing product specific and/or… more