- Sanofi Group (Cambridge, MA)
- …Coordinate with CRDs in the project, Global Project Head, The PV Rep, Regulatory + Provide expertise in the fields of clinical development and autoimmune conditions. ... management plans to assure successful execution of the clinical trials in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well… more
- Lilly (Boston, MA)
- …management of iPSC Master and Working Cell Banks, ensuring traceability, testing compliance , and alignment with regulatory expectations. + Drive the development ... preparation, and formulation workflows. + Collaborate cross-functionally with Quality, Regulatory , Analytical Development, and Manufacturing (CDMOs) to support CMC… more
- Beth Israel Lahey Health (Boston, MA)
- …of patients for participation in multiple clinical trials, ensuring compliance with federal, state and institutional guidelines. Financial responsibilities including ... the progress of protocols; planning and prioritizing the work. Management of regulatory aspects of the study, including interaction with Institutional Review Board.… more
- Pfizer (Andover, MA)
- …the site. Ensure materials are received, stored, moved and shipped on-time. Ensure compliance with all regulatory requirements as they pertain to the warehouse ... and in accordance with all applicable company, department, and regulatory requirements (FDA, cGMP, DOT, Hazmat, EPA, FAA etc.)...across the site. + Train warehouse staff and ensure compliance with all relevant SOPs and policies. Provide leadership… more
- Charles River Laboratories (Shrewsbury, MA)
- …+ Analyze basic to moderately complex laboratory assays based on protocols and in compliance with SOPs and GLP regulations. + Record project data in accordance with ... Zero to two years related laboratory experience, preferably in a pharmaceutical or contract laboratory environment. An equivalent combination of education and… more
- Dana-Farber Cancer Institute (Milford, MA)
- …Monitors the environment of care with attention to patient safety and assures compliance with regulatory agency standards. + Complies with applicable policies, ... response to interventions. + Documents care according to Institute and regulatory agencies' requirements. + Administers medications and other treatments, which may… more
- Charles River Laboratories (Wilmington, MA)
- …accurate and efficient in-take and log-in of client samples and material; ensure compliance with internal SOPs and timelines to enable timely initiation of client ... (ie process improvements, harmonization). * Ensure adherence to pertinent regulatory requirements and to departmental policies, GMP practices, and procedures… more
- Sanofi Group (Cambridge, MA)
- …Integrate activities of multi-disciplinary team including, clinical, research, translational, pharmaceutical development, supply chain, etc. in order to advance drug ... development projects + Work with project core team members (clinical, research, regulatory , etc.) to translate target specific biology or clinical knowledge into… more
- Takeda Pharmaceuticals (Boston, MA)
- …through the integration of new technologies, methodologies, and best practices. + Regulatory Compliance : Ensure all activities comply with relevant regulatory ... Qualifications: + Experience: Experience in a leadership role within a large pharmaceutical or biotechnology company is highly desirable. + A proven track record… more
- Charles River Laboratories (Worcester, MA)
- …including chromatography and mass spectrometry systems. Other: Full understanding of regulatory requirements of study types assigned, as well as Testing Facility ... of 7 years related experience in the contract research, academic, or pharmaceutical industry. An equivalent combination of education and experience may be accepted… more