- J&J Family of Companies (Cambridge, MA)
- …and external human data resources. + Partner with Clinical Development, Global Regulatory Affairs , Data Science, Patient Reported Outcomes, Statistics and other ... core functions in Precision Measures (including Biomarkers & Imaging) to contribute to holistic measurement plans (across molecular, imaging, digital, clinical and other measures) for our compounds in development. + Develop relationships with key scientists… more
- Eversource Energy (Westwood, MA)
- …\(5\+ year\) range distribution plans\. + Supports the community relations and regulatory affairs teams for clear communications on the Company's electrification ... status reports\. + Supports any related documentation and/or testimony to support regulatory filings\. + Presents recommendations and/or results to all levels of… more
- Sumitomo Pharma (Boston, MA)
- …but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs , Data Management and Biostatistics is essential. ... as required. + Coordinate responses to ad hoc safety issues such as regulatory authority, site, or health care professional requests, along with PV physician,… more
- Philips (Cambridge, MA)
- …including Medical Affairs , Clinical Development, Research & Development, and Regulatory Affairs . + **Develops** clinical evidence strategies for New Product ... a key member of the Ultrasound Medical and Clinical Affairs team and serves as a subject matter expert,...to support medical device performance in alignment with EU regulatory standards (MEDDEV 2.7.1 Rev. 4, EU Medical Device… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …chemistry, analytical development, drug product development, manufacturing, quality assurance, and regulatory affairs , to develop and implement effective process ... or business processes. + Responsible for authoring relevant sections of regulatory documents, validation plans, development reports, process flow diagrams (PFDs),… more
- Takeda Pharmaceuticals (Boston, MA)
- …functions (eg project management, clinical monitoring, data management process, regulatory affairs , pharmacovigilance, etc.) to enable meaningful dialogue ... within Takeda and with partners. + Proven experience in Alliance/Partnership excellence: deep understanding/experience of building, maintaining, and closing partnerships including tools/methods. + Expertise in the ability to perform root cause analysis,… more
- Rhythm Pharmaceuticals (Boston, MA)
- …or related field + 8+ years of highly relevant pharmaceutical/biotechnology experience in Regulatory Affairs Operations + Knowledge and understanding of the drug ... to overcome barriers, together. Opportunity Overview The Associate Director (AD) of Regulatory Operations is responsible for assisting the Head of Regulatory … more
- Sanofi Group (Cambridge, MA)
- …of relevant pharmaceutical/biotechnology experience, including at least 4 years of relevant Regulatory Affairs experience (regional and global), in early and ... **Job Title:** Regulatory Strategist **Location:** Morristown, NJ/Cambridge, MA **About the...accelerate progress. As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global… more
- Eversource Energy (Westwood, MA)
- …System Planning, Engineering, Siting, Real Estate, Legal, Project Management, Engagement, Regulatory Affairs , Environmental Affairs , and other internal ... System Planning, Engineering, Siting, Real Estate, Engagement and Equity, Regulatory , Procurement, Legal, Scheduling, and later\-stage Project Management\. This role… more
- Medtronic (Boston, MA)
- …Collaborate cross-functionally with software development, systems engineering, quality assurance, and regulatory affairs teams to ensure seamless integration and ... verification of software components. + Participate in design reviews, risk assessments, and project planning to provide early feedback on software design and testability. + Contribute to the strategic planning and continuous improvement of the overall software… more