- Charles River Laboratories (Shrewsbury, MA)
- …study management, interpretation, and reporting of study data and assuring the regulatory compliance of these projects, as appropriate. Serve as a Project Scientist ... protocols/plan in accordance with company standard operating procedures and industry regulatory guidelines. This position will serve as the primary scientific… 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 include ... protocols/plan in accordance with company standard operating procedures and industry regulatory guidelines. This position will serve as the primary scientific… more
- Sanofi Group (Cambridge, MA)
- …program strategy and the network of collaborators from research to operational, regulatory , and commercial functions. Success in this role requires the ability to ... The GPH will be delegated such responsibilities as interaction with regulatory /health authorities, approval of protocols, informed consent documents, clinical study… more
- Chiesi (Boston, MA)
- …Direct global early access and compassionate use programs, ensuring compliance with varied regulatory frameworks (eg, FDA , EMA, and other health authorities). + ... than 6,000 employees (Chiesi Group). To achieve its mission of improving people's quality of life by acting responsibly towards society and the environment, the… more
- Cambrex High Point (Waltham, MA)
- …manufacturing and tech transfer of peptide APIs. + Strong understanding of regulatory guidelines (ICH Q8/Q9/Q11, FDA /EMA expectations) and process validation. + ... customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities… more
- Abbott (Westford, MA)
- …work environment. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... meet new product introduction schedules, and enhance productivity and product quality . **MAIN RESPONSIBILITIES** + Provide leadership to engineering and facilities… more
- Sanofi Group (Cambridge, MA)
- …strategic business support to maintain Sanofi's commitment to ethical practices and regulatory compliance. We are an innovative global healthcare company with one ... monitoring program across multiple Business Units to ensure compliance with regulatory requirements, internal policies, and product messaging + Maintain robust… more
- Children's Hospital Boston (Boston, MA)
- …appropriate regulatory agencies. + Collaborates with physicians, nursing, and quality programs to ensure clinical policies and procedures are compliant with ... committees related to transfusion medicine. + Ensures compliance for inspection by regulatory bodies overseeing hospital enterprise wide transfusion ( FDA , AABB… more
- System One (Harvard, MA)
- …Actions. + Decision making of non-conformance through a deep understanding of Quality Systems Regulatory expectations + Reviews and approves Quality ... Contract, Potential for extension or conversion to permanent Responsibilities + Provides Quality Assurance (QA) support to Devens Site and reporting Manger through … more
- Lilly (Boston, MA)
- …and scientific data generated both internally and externally are in line with quality and regulatory expectations. + Understand in-process and final product ... critical quality attributes to support a research to development (R...test protocols, SOPs, technical reports, and relevant sections of regulatory submissions. Participate in regulatory interactions as… more