- Takeda Pharmaceutical Company Limited (Lexington, MA)
- …program management experienced in leading cross-functional clinical programs within Medical Affairs , Clinical Research, Regulatory , CMC or other drug development ... phases of development with significant experience within related functions (eg, Medical Affairs , Clinical Operations, Regulatory , CMC, Marketing). Minimum of 5… more
- IMS Group (Cambridge, MA)
- …team and internal partners such as clinical operations, translational medicine, regulatory affairs , biostatistics, drug discovery, drug safety, marketing Advance ... Review documents supporting clinical development such as Investigator's brochure, regulatory documents for IND/CTA, clinical sections of integrated development… more
- Takeda Pharmaceutical Company Limited (Boston, MA)
- …inspire you and empower you to shine? Join us as a Executive Medical Director , Oncology Clinical Sciences in our Cambridge office. At Takeda, we are transforming the ... people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for… more
- Vertex Pharmaceuticals (Boston, MA)
- …and software/tools Own statistical support in the therapeutic areas and/or Global Medical Affairs he/she leads including early/late clinical developments, ... Job Description General Summary: The Executive Director of Biostatistics is a strategic, dynamic, and empowered leader, overseeing statistical functions in support… more
- Takeda Pharmaceutical Company Limited (Boston, MA)
- …functions (eg project management, clinical monitoring, data management process, regulatory affairs , pharmacovigilance, etc.) to enable meaningful dialogue ... and empower you to shine? Join us as the Director , Supplier Relationship Management (FSP) based in Cambridge, MA...towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work… more
- Vertex Pharmaceuticals (Boston, MA)
- …liaison between Clinical Development and other internal groups at Vertex (eg, Regulatory Affairs , Clinical Operations) for assigned studies Represents Vertex to ... Job Description General Summary: The Clinical Development Medical Director will serve as the Medical Lead for Vertex clinical trials, working with cross-functional… more
- Glycomine (Boston, MA)
- …etc). Collaborate cross functionally with internal teams, including Clinical Development, Regulatory Affairs , Translational Medicine and Program Leadership to ... activities are performed prior to each site activation. Work closely with the Director of Clinical Operations to review the study timelines and milestones are being… more
- Northeastern University (Boston, MA)
- …to develop the business unit. Collaborate with cross functional teams including Medical Affairs , Regulatory Affairs , Legal, Value & Access and Finance ... based in Cambridge, MA. About Ipsen Biopharmaceuticals, Inc.: Ipsen is a global , biopharmaceutical group focused on innovation and specialty care. The group develops… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) ... Your skills could be critical in helping our teams accelerate progress. The Associate Director , Global Regulatory Affairs - Global Labeling Strategy… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) **About the ... families. Your skills could be critical in helping our teams accelerate progress. The Director , Global Regulatory Affairs - Global Labeling Strategy… more
- Takeda Pharmaceuticals (Boston, MA)
- …what is possible in order to bring life-changing therapies to patients worldwide. The Director Global Regulatory Affairs , Neuroscience is responsible for ... andbuilding appropriate regulatory strategy. + Participates in cross-functionalinitiativeswithin Global Regulatory Affairs and Takeda R&D. **How… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and Promotion ... prescription medicine promotion. **How you will contribute:** + As our Associate Director , Global Regulatory Affairs Advertising and Promotion lead you… more
- Takeda Pharmaceuticals (Boston, MA)
- …Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC. **How you will contribute:** + Plan, ... meetings, international experience preferred. + Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. The Senior Global Regulatory Affairs , Neuroscience is responsible for developing ... Teams (GRTs) and representing the regulatory function on cross-functional Global Program Teams. The Senior Director also will lead discussions of… more
- Takeda Pharmaceuticals (Boston, MA)
- …my knowledge. **Job Description** **Objective / Purpose:** + Defines, develops and leads global strategies to maximize global regulatory success towards ... + Provides leadership and development for direct reports, including those that serve as global regulatory leads responsible for the design and execution of … more
- Fresenius Medical Center (Waltham, MA)
- …+ 12+ years of experience in regulatory affairs , focusing on regulatory strategy, submissions, and global market access in the pharmaceutical industry. + ... Regulatory Strategy Leadership:** + Lead the development of global regulatory strategies for the company's pharmaceutical...a Master's, PhD, or MBA is highly preferred). + Regulatory Affairs Certification (eg, RAC) is preferred.… more
- Takeda Pharmaceuticals (Boston, MA)
- …understands probabilities of technical success for the solutions. + Effectively represent the Global Regulatory Affairs (GRA) function in senior level ... for providing strategic guidance and oversight for the delivery of global regulatory strategies to support development of biomarkers, diagnostic tests, devices… more
- Takeda Pharmaceuticals (Lexington, MA)
- …and approves - as needed - technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards. + When in a GRA CMC Product ... tactical regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and / or commercial products approvals… more
- Rhythm Pharmaceuticals (Boston, MA)
- …commercialization and life cycle of Rhythm products. This role reports into the Director , Global Regulatory Affairs . Responsibilities and Duties ... to overcome barriers, together. Opportunity Overview In the Associate Director , Regulatory Affairs role, you...execution of regulatory filings, maintaining compliance with global regulatory standards and commitments. You will… more
- Sumitomo Pharma (Boston, MA)
- …, Regulatory Advertising & Promotion** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...function as the Regulatory reviewer for assigned products. This position is responsible… more
