- Sanofi Group (Cambridge, MA)
- …while maintaining full compliance with relevant company, industry, legal and regulatory requirements + Demonstrate operational understanding and risk management by ... sharing information and answering questions based on approved material within Regulatory guidelines. + Engages with appropriate stakeholders to understand the state… more
- State of Massachusetts (Boston, MA)
- …Director ("AED") assists the Executive Director ("ED") with the administration and regulatory functions of the Unit, including collaboration with the BBRS and its ... position requires someone with great attention to detail who enjoys regulatory work, facilitating conversations regarding technical regulatory matters, improving… more
- 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. ... support + Answer to medical questions raised by EC/IRBs, sites **Contribution to regulatory and safety documents and meetings:** + Represents his/her project at key … more
- Children's Hospital Boston (Boston, MA)
- …on planning, design, and implementation, ensuring conformance with hospital and regulatory standards. + Serving as Project Manager for designated projects and ... drawings, RFIs, submittals, and shop drawings, to ensure contractor product submissions are on schedule, Architect/Engineer reviews are timely and complete, and… more
- Sanofi Group (Cambridge, MA)
- …nonclinical safety strategies, designing safety pharmacology and toxicology studies, authoring regulatory documents, being a member of an integrated Project Team, ... internal and external partners, and interacting with and responding to global regulatory agencies. In addition, you will review compounds for potential in-licensing… more
- Hologic (Marlborough, MA)
- …diagrams. + Collaborate with cross-functional teams (Product Engineering, DevSecOps, Regulatory , Quality) to integrate security into the product lifecycle. + ... their operating environments. + Collaborate with Program Management and Regulatory teams to provide security input for audits and...teams to provide security input for audits and FDA submissions . + Maintain current knowledge of FDA and other… more
- Dana-Farber Cancer Institute (Boston, MA)
- …of cell processing protocols, ensuring efficiency, scalability, and adherence to regulatory standards. Is responsible to insure alignment between Sponsor and CMCF ... documentation. + Regulatory Compliance: Stay current with industry regulations and standards...developing validation protocol, and collaborating with sponsors on IND submissions . + Works closely with Manager and Technical Director… more
- State of Massachusetts (MA)
- …support to other MGC divisions, the Network Operations Center (NOC), and regulatory compliance with MGC licenses. This position assists with implementing and ... MGC policies, procedures, systems operations, and requirements. * Act as regulatory gaming and sports wagering compliance representative for the MGC, working… more
- Beth Israel Lahey Health (Boston, MA)
- …and other sponsored grant activity. Remain abreast of current trends, practices, regulatory and/or policy changes of granting entities, which may impact internal ... to ensure compliance with all regulations. + Ensure all regulatory trainings and approvals are met before and after...and approvals are met before and after all grant submissions and awards are made, including but not limited… more
- Carrington (Boston, MA)
- …and other assessment documentation to ensure compliance with audit controls and regulatory requirements. + Create and maintain a repository of support documentation ... for audit/assessment submissions to ensure consistency across all requests. + Actively...+ Ensure the continuity and accuracy of audit and regulatory responses. + Review the IT Department policies and… more
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