- Merck & Co. (Boston, MA)
- …studies.Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.Specifically, the Executive Director may be… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. As an Associate Director, Global Regulatory Affairs Marketed Products you will ... area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively… more
- Veterans Affairs, Veterans Health Administration (Bedford, MA)
- Summary This position is located in the Associate Director's Office at the VA Bedford Healthcare System. This position is full-time at 40 hours per week. ... influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP) Participation in the Coronavirus Disease 2019… more
- Takeda Pharmaceuticals (Lexington, MA)
- …of proposed promotional and disease state materials. + Collaborate with Regulatory Affairs , Medical, Legal, Commercial, and Compliance, execute and ... of my knowledge. **Job Description** Join Takeda as an Associate Director, US Advertising & Promotion Regulatory ... regulatory requirements. + Understand broad concepts within Regulatory Affairs and potential effects across the… more
- Takeda Pharmaceuticals (Boston, MA)
- …Regulatory Project Management and Strategic Planning - GI2 TAU within our Global Regulatory Affairs organization, based remotely. + Partners with the Global ... through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global ...around the world. This position is currently classified as " remote " in accordance with Takeda's Hybrid and Remote… more
- Takeda Pharmaceuticals (Boston, MA)
- …area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively ... area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively… more
- Takeda Pharmaceuticals (Boston, MA)
- …FDA/EMA/PMDA regulations; ICH guidance; GLP/GCP requirements; SEND requirements, etc.). + Regulatory Affairs Credential (RAC-Drugs) is an advantage. + Strong ... to the best of my knowledge. **Job Description** **About the role:** ** Associate Director, Nonclinical Regulatory Writing and Submission Support,** **_Oncology… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director, Global Labeling Lead where you will be responsible for the ... and assures that Takeda labeling content and processes conform to regulatory requirements. Management of Local Exceptions and LOC Interactions + Manages… more
- Takeda Pharmaceuticals (Boston, MA)
- …all applicable laws, regulations, and policies + Interact directly with Clinical, Statistics, Regulatory Affairs , and Medical Affairs to fully understand ... and be empowered to deliver your best. As part of the Global Medical Affairs Oncology team, you will report to the Scientific Communications Group Lead, Solid… more
- Commonwealth Care Alliance (Boston, MA)
- …guidance, direction, and practical translation of privacy requirements (legal, regulatory , contractual and, as applicable, those emanating from national ... direct and indirect reports, and may have dotted line and/or regulatory /governance oversight responsibility of other relevant areas. **Supervision Exercised:** +… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …**Job Description** **About the role:** Reporting into Global Medical Communications, the Associate Director, Global Medical Affairs Congress Excellence Lead is ... and manage the annual congress strategic planning process for Global Medical Affairs (including forecasting +3 years) and ensuring proper linkage to the Annual… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …to the best of my knowledge. **Job Description** **About the role:** The Associate Director, Global Medical Communications is a dynamic, strategic role within Global ... Medical Affairs that collaborates with cross-functional partners to oversee one...Medical Communications planning and execution for GI + The Associate Director, Global Medical Communications leads and is accountable… more
- Bristol Myers Squibb (Devens, MA)
- …Stability, Analytical Development, Process Development, Manufacturing Sciences and Technologies, Regulatory Affairs , and other Cell Therapy Development ... QA, QC, analytical and process development, manufacturing sciences and technology, and regulatory affairs functions. + Supports the overall product quality… more
- Elevance Health (Woburn, MA)
- …and tactical issues. + Work collaboratively with other teams, including legal, compliance, regulatory affairs , in supporting the business. + In a complex and ... ** Associate General Counsel Sr. - Pharmacy** **Location:** This position will work a hybrid model ( remote and office). The ideal candidate will live within 50… more
- Merck (Boston, MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. **Specifically, The Senior Clinical Director May… more
