- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …cross-functionally with analytical team members, process chemistry, formulation development, regulatory affairs , quality assurance, and other departments to ... drug substance and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols and timelines,… more
- Beth Israel Lahey Health (Boston, MA)
- …an office in the Sponsored Programs Administration Division under Research and Academic Affairs whose mission is to facilitate the conduct of research at Beth Israel ... Deaconess Medical Center (BIDMC). SPC is the central research administration...status data into tracking system. (essential)** **Identifies and mitigates regulatory compliance, legal, intellectual property, and other risks. (essential)**… more
- Sumitomo Pharma (Boston, MA)
- …but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs , Data Management and Biostatistics is essential. ... PV Operations on cross-functional program and project teams; support PV Medical Safety activities on cross-functional program and project teams, as required.… more
- Sanofi Group (Cambridge, MA)
- … standards for radiopharmaceuticals across regions. + Partner with Quality and Regulatory Affairs to maintain audit readiness and ensure patient safety. ... Serve as the strategic interface between Sanofi's internal teams (Manufacturing, Commercial, Medical , Regulatory ) and external partners (notably Orano Med and… more
- Sanofi Group (Cambridge, MA)
- …with strategically important account development. It also works cross-functionally with Sales, Medical , Training, Payer Access & Public Affairs (PA&PA), Patient ... integrated into key account strategies + Collaborate across marketing, medical , training, payer access & public affairs ,...budget management & presentation skills + Experience with MLR ( Medical , Legal, Regulatory ) review process a plus… more
- Pfizer (Cambridge, MA)
- …and external partners, such as project leaders, research units, biostatistics, regulatory affairs , clinical pharmacology, human genetics, translational oncology, ... clinical study reports (CSRs), investigator brochures, statistical analysis plans, and regulatory documents. + Foster a transparent environment that builds strong… more
- Hologic (Marlborough, MA)
- …compliance. + Collaborative and team-oriented, building strong relationships across R&D, Regulatory Affairs , Manufacturing, and other key stakeholders. + ... Are you passionate about driving innovation while ensuring compliance and quality in medical device development? At Hologic, we are seeking a **Lead Design Assurance… more
- Eliassen Group (Boston, MA)
- …risk management, and communication across all stakeholders. * Coordinate with Regulatory Affairs to ensure documentation and submission readiness for ... http://careers.eliassen.com/iXUiCO + Description + Recommended Jobs **Description:** Our Fortune 500 Medical Device client is seeking a Project Manager to lead a… more
- Bristol Myers Squibb (Devens, MA)
- …standards across all lab operations. + Collaborate with QC, Analytical Development, and Regulatory Affairs to support product release and regulatory ... position plays a key role in maintaining data integrity, supporting regulatory inspections, and driving continuous improvement across quality control laboratories.… more
- State of Massachusetts (Boston, MA)
- …of Insurance ("DOI"), an Agency within the Office of Consumer Affairs and Business Regulation, administers the Commonwealth's insurance consumer protection laws ... of providers, or that employ utilization review systems to evaluate the medical necessity and appropriateness of requested health care services. The primary purpose… more