- Merck & Co. (Boston, MA)
- Job DescriptionPosition Description:The Vice President, Regulatory Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory ... strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel medicines.Contributing to the continuous improvement of the… more
- Merck & Co. (Boston, MA)
- Job DescriptionThe Associate Vice President (AVP)/Section Head , Global Clinical Development, Pediatrics will focus on driving strategy, development, and life-cycle ... vaccine projects, including pipeline candidates and licensed products. The Section Head manages Product Development Team (PDT) leaders and clinical directors… more
- Merck (Boston, MA)
- **Job Description** Position Description: The Vice President, Regulatory Affairs, General Medicine, will contribute to the mission and vision of the Global ... Regulatory Affairs and Clinical Safety (GRACS) function of Our...working a Hybrid work consisting of three total days on- site per week, Monday - Thursday, although the specific… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Compliance Head - US FDA **Location** : Framingham, MA, Morristown, NJ **Job Title:** Compliance Head - US FDA **Location** : Framingham, MA, ... secure product launches and support compliance through audits, inspections, regulatory surveillance, and advocacy. Grounded in core values Integrity, Collaboration,… more
- Bristol Myers Squibb (Cambridge, MA)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . **VP, Head of Data Sciences & Advanced Analytics** **Position Summary:** We are ... seeking a highly skilled and experienced Head of Data Science and Advanced Analytics to lead...for decision-making across the drug development cycle, generation of regulatory -ready evidence and real-time risk monitoring. Ensure proper data… more
- Merck (Boston, MA)
- **Job Description** The Associate Vice President (AVP)/Section Head , Global Clinical Development, Pediatrics will focus on driving strategy, development, and ... vaccine projects, including pipeline candidates and licensed products. The Section Head manages Product Development Team (PDT) leaders and clinical directors… more
- Dana-Farber Cancer Institute (Boston, MA)
- The Clinical Research Coordinator work within the Head & Neck Oncology clinical research program and support the research team in the overall conduct of clinical ... protocol related samples including shipment to outside entities as required. Maintains regulatory binders and ensures study compliance with all state, federal, and… more
- Astellas Pharma (Cambridge, MA)
- ** Head , Discovery, Targeted Therapy** Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are ... cancer biology in the context of diseases such as GI/GU cancers is crucial. The Head , Discovery, Targeted Therapy, will report to the Head , Cancer Biology and be… more
- Sanofi Group (Framingham, MA)
- …and funding's. + Execution + Coordinate all the functions required at site ( Regulatory , Quality, Production, Supply Chain, Procurement, Engineering, MSAT, SMS) ... **Job Title:** Head of Sanofi Manufacturing System (SMS) Supplier Excellence...team is to drive industrial performance to achieve the site 's strategy and ambition. The OpEx team brings a… more
- Sanofi Group (Framingham, MA)
- …Pharmacovigilance, Manufacturing, Site Quality Head for a Manufacturing Site , etc.). + Previous experience as a Regulatory Authority Inspector. + ... secure product launches and support compliance through audits, inspections, regulatory surveillance, and advocacy. Grounded in core values Integrity, Collaboration,… more
- Pfizer (Cambridge, MA)
- …practices; drive relentless digital innovation; ensure unwavering compliance with global regulatory standards; and act as a trusted strategic advisor to the ... Head of Medical Affairs and other vaccines senior leaders....new science data, shifts in public opinion, and evolving regulatory landscapes to modify and refine the Pfizer global… more
- Takeda Pharmaceuticals (Lexington, MA)
- …of action items and deliverables, distribution of minutes, and maintenance of relevant SharePoint site (or equivalent). + Partners with the Head of US Medical ... and Investigator Initiated Research (IIR). Specific objectives include: + Partners with Head of US Medical Clinical Science Lead to translate strategy into… more
- Bristol Myers Squibb (Cambridge, MA)
- …and Quality and Compliance leadership + The role will report directly to the Head of Clinical Development and will deputize as required, and will be a core ... supervise and have accountability for the clinical components of regulatory filings + Will contribute to overall strategy for...experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location.… more
- Bristol Myers Squibb (Cambridge, MA)
- …quality delivery of innovative protocols and data packages for CSRs and Regulatory Filings. The Program Lead oversees all clinical studies within assigned ... * May serve as a delegate of Clinical Scientist Head as needed * Partners with the Clinical Development...of innovative protocols and data packages for CSRs and Regulatory Filings * Oversees all clinical studies within assigned… more
- Bristol Myers Squibb (Cambridge, MA)
- …of the oncology pipeline. **Summary** Reporting to the Solid Tumor Lung Disease Head in Translational Medicine, the incumbent will be part of the translational group ... oncology. + Manage relationships with key internal stakeholders including regulatory , clinical and commercial and scientific communications and external… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Takeda's commitment to sustainability and safety. You will report into the Head , Environmental Compliance and Sustainability. **How you will contribute:** + Maintain ... regulations, as well as Takeda's internal policies. + Provide expertise, either on- site or remotely, to assist sites with the investigation and resolution of… more
- Veolia North America (Hudson, MA)
- …site . **Required Certification/Licenses/Training:** + Minimum water/wastewater license as required by regulatory agency at site . + Must possess a valid ... I and II First Responder Certification if required by site . + Obtain and maintain minimum water / wastewater...ground; and works with hands extended above and below head and body up to 40 minutes using hand… more
- Veolia North America (Westborough, MA)
- …**Required Certification/Licenses/Training:** + Minimum water / wastewater license as required by regulatory agency at site . + Must possess a valid driver's ... I and II First Responder Certification if required by site . + Minimum water / wastewater operator state certification....ground; and works with hands extended above and below head and body up to 40 minutes using hand… more
- GE HealthCare (Boston, MA)
- **Job Description Summary** Reporting to the Global Head of Imaging & Digital, you will join our Imaging & Digital Group, within the R&D department of GE ... strategy and formalize this in study documents including imaging manual, quality manual, site training materials and image review charter + Advise imaging staff at… more
- Option Care Health (Boston, MA)
- …career.** Option Care Health, Inc. is the largest independent home and alternate site infusion services provider in the United States. With over 8,000 team members ... plans to achieve goals of targeted opportunity. + Complies with accreditation, legal, regulatory , and safety requirements and assures their team does the same. +… more
