- Orchard Therapeutics (Boston, MA)
- …effective cross-functional collaboration with Clinical Operations, Data Management, Biostatistics, Regulatory , Medical Affairs , Pharmacovigilance and other teams ... of third party vendors . Monitors departmental progress on program objectives and develops contingency plans as needed ....reporting, management, and operations . Desired experience - US regulatory environment, US government affairs Skills .… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …the organizations mission, vision, scientific objectives and business goals + Collaborate with senior leaders to help integrate medical affairs into the overall ... of regulatory guidelines and compliance requirements relevant to medical affairs activities. + Proven leadership and people management skills and the ability… more
- Eversource Energy (Westwood, MA)
- …to help manage resolution through the corporate Claims process\. + Work with Government Affairs and Regulatory Affairs to ensure that key state/federal ... respective SMEs, e\.g\., Community Relations, Corp Communications, Media Relations, Gov't Affairs , Regulatory , Environmental, Real Estate, etc\. + Develop… more
- Sanofi Group (Cambridge, MA)
- …Global Project Head (GPH) is delegated various responsibilities by the Senior GPH and/orTherapeutic Area Head to provide leadership, supervision, and coordination ... The GPH position requires achieving results through others and supporting the senior management team in achieving corporate goals. The GPH establishes the goals… more
- State of Massachusetts (Boston, MA)
- …of Occupational Licensure (DOL), an agency within the Office of Consumer Affairs and Business Regulation (OCABR), protects consumers by making sure the professionals ... Provide written and oral advice to the Agency on regulatory matters related to MSAC. * Establish and maintain...standards at sanctioned events. *Direct MSAC Investigation and Compliance Program ** ** ** * Assign and monitor MSAC complaints… more
- Astellas Pharma (Cambridge, MA)
- …enterprise objectives. -Play a strategic lead role, in collaboration with Research, Regulatory Affairs and Early Development and Translational Sciences, to ... with other Medical Heads across Oncology and Biopharma/Cell&Gene and with senior leadership of Clinical Operations, Quantitative Sciences, Regulatory and… more
- Bristol Myers Squibb (Cambridge, MA)
- …(Masters, PhD, PharmD, BSN, etc.) with at least 3+ years of Regulatory Affairs experience in the pharmaceutical industry. **Key Competency Requirements** ... issues, and risks in written and verbal format to regulatory senior leadership team and other governing...Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources… more
- Sanofi Group (Cambridge, MA)
- …leaders, patient advocacy associations, clinical development, Global Medical Leadership, Regulatory , Medical Affairs , Product Communications, and lead agency ... and science story in partnership with Clinical Development and Global Medical Affairs . + Provide oversight and commercial accountability for Global Corporate … more
- Takeda Pharmaceuticals (Boston, MA)
- …patients worldwide. The Director, PMO Project Management will support the Global Regulatory Affairs (GRA) Initiatives PMO by leading departmental and enterprise ... a plus. + Strong understanding of R&D drug development, with experience in regulatory affairs , clinical, or pharmacovigilance. + 10+ years of experience in… more
- Cardinal Health (Mansfield, MA)
- …pharmaceutical products of Cardinal Health. Chemistry Services is a part of Quality, Regulatory & Medical Affairs (QRMA) Scientific Services. Under the umbrella ... use specialized instruments to perform Assay and impurity/degradant tests for stability program for solid dose pharmaceuticals. **_This role is 100% onsite at our… more