- Merck & Co. (Boston, MA)
- Job DescriptionThe Senior Director ( Sr . Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving ... execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director May Be Responsible For: Evaluating pre-clinical and… more
- Merck & Co. (MA)
- Job DescriptionThe Senior Director ( Sr . Principal Scientist) has primary responsibility for the strategic planning and directing clinical research activities ... execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Senior Director May Be Responsible For:Evaluating pre-clinical and… more
- Pfizer (Cambridge, MA)
- …and external partners, such as project leaders, research units, biostatistics, regulatory affairs , clinical pharmacology, human genetics, translational oncology, ... study reports (CSRs), investigator brochures, statistical analysis plans, and regulatory documents. Foster a transparent environment that builds strong partnerships… more
- Sumitomo Pharma (Boston, MA)
- …a dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs (Oncology).** The Associate Director ... is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will...Comfortable presenting to all levels of the organization including Senior Management. **Education and Experience** + Bachelor's degree in… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …possible in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and Promotion (GRA ... promotion. **How you will contribute:** + As our Associate Director , Global Regulatory Affairs Advertising...if there is new data or campaigns that require senior level management input or alignment. + Strategic business… more
- Sanofi Group (Cambridge, MA)
- …departmental activities, and direct reports. + In conjunction with the Sr . Director /Product Support Head, imparts senior regulatory guidance and advice ... **Job Title:** Director , US Regulatory Affairs - Advertising and Promotion (Hybrid) **Location:** Cambridge, MA Morristown, NJ **About the Job** Are you… more
- Bristol Myers Squibb (Cambridge, MA)
- …. **Position Summary** The Director of Early Precision Medicine Regulatory Affairs leads global regulatory strategy for biomarkers ... Solid scientific background, PhD., MD, PharmD, MS + Significant experience in regulatory affairs and diagnostic-related development eg, >8-10 years. + Scientific… more
- Evident Scientific (Needham, MA)
- Sr . Mgr., Regulatory Affairs (RA)...inspections, and QMS compliance activities. Reporting to the Global Director of Regulatory Affairs - Clinical ... compliance, and operational excellence across global and regional projects. **Key Responsibilities** ** Regulatory Affairs (US Focus)** + Act as US regulatory… more
- GRAIL (Boston, MA)
- …products with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval ... and leadership. They may manage and provide direction to regulatory staff and, when required, participate in senior...of Standard Operating Procedures and policy guidelines within the regulatory affairs department. + Perform other duties… more
- Cengage Group (Boston, MA)
- …day. To learn more, please see https://www.cengagegroup.com/about/inclusion-and-belonging/ . The ** Senior Director of** **State** **Government Affairs ** ... Chief Communications Officer and work in partnership with the Sr Director of Federal Government Affairs...+ Use your deep knowledge of state legislative and regulatory processes to create strategies for effective engagement that… more
