- Merck (Cambridge, MA)
- …external vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug discovery and ... and interpretation of data. + Maintain a comprehensive understanding of global regulatory expectations and shape, present and defend regulatory documents and… more
- Sanofi Group (Cambridge, MA)
- …to the protocol development, study feasibility and risk assessment, regulatory submissions, protocol training, scientific review of data, and cross-functional ... validation of clinical data. + Participate in internal governance and regulatory meetings. **Cross-Functional Collaboration** + Serve as the scientific reference for… more
- Takeda Pharmaceuticals (Lexington, MA)
- …design verification and validation testing, risk assessments, DHF creation, regulatory submission authoring, general project team technical support, and extensive ... Lead or assist in deviation, complaint and failure investigations. + Author regulatory Common Technical Document (CT) to support submission. + Mentor engineering… more
- Takeda Pharmaceuticals (Boston, MA)
- …aspects of signal detection/safety review activities. + Draft responses to regulatory /ethics safety questions. + Close working relationship with physicians, both ... + Perform ad hoc analyses eg in response to regulatory queries. + Integral to Global Safety Teams and...reports for product safety profile and addressing safety -elated regulatory authority requests (2 years); apply clinical trial methodology,… more
- Bristol Myers Squibb (Cambridge, MA)
- …data to support development + Serving as principal functional author for Regulatory submission, study reports, and publications + Provides oversight and medical ... of the literature + Keeps abreast of development and regulatory issues related to other competitive or relevant compounds...**Degree Requirements** + Advanced degree(s) in relevant field: MD, MD/ PhD (or x-US equivalent) and clinical expertise in a… more
- Sanofi Group (Cambridge, MA)
- …strategy, and the network of collaborators from preclinical research to operational, regulatory and commercial functions. Success in this role requires the ability ... The GPH will be delegated such responsibilities as interaction with regulatory /health authorities, approval of protocols, informed consent documents, clinical study… more
- Charles River Laboratories (Shrewsbury, MA)
- …study management, interpretation, and reporting of study data and assuring the regulatory compliance of these projects, as appropriate. Serve as a Project Scientist ... protocols/plan in accordance with company standard operating procedures and industry regulatory guidelines. This position will serve as the primary scientific… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …to post commercialization; with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director, GCD is responsible for all the ... + Formulating a rationale to develop the drug in accordance with a clinical and regulatory strategy. + Working with experts and consultants in the field to refine a… more
- Bristol Myers Squibb (Boston, MA)
- …on translational data generated to support asset development and contribute to regulatory submissions. This individual will work on cross-functional project teams to ... scientists, as well as BMS members from clinical, medical, commercial, regulatory , and diagnostics. Individual will also engage with external academic… more
- Charles River Laboratories (Shrewsbury, MA)
- …management, interpretation, and reporting of study data and assuring the regulatory compliance of these projects, as appropriate. Additional responsibilities include ... protocols/plan in accordance with company standard operating procedures and industry regulatory guidelines. This position will serve as the primary scientific… more