- Bausch + Lomb (Columbus, OH)
- …advancement of eye health in the future. **Objectives** A member of the global technical CMC team for global regulatory CMC strategy for submissions and ... surveillance and US regulatory licensing. **Responsibilities** + Proactively communicate CMC regulatory strategy, key issues and any other critical topics… more
- West Pharmaceutical Services (Exton, PA)
- …Requisition ID: 66496 Date: Sep 12, 2024 Location: Exton, Pennsylvania, US Department: Regulatory Affairs Description: **Who We Are:** At West, we're a dedicated ... Project Management (RPM) role is responsible for management of regulatory affairs projects associated with West's global...IEC 62304, ISO 11608), 21 CFR Part 820 and CMC regulatory requirements. + Experience in medical… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …of pharmaceutical drug and device development process. + Experience in Regulatory Affairs /Operations/information preferred. + Knowledge and practical experience ... with internal and external key stakeholders: including Chemistry Manufacturing and Controls ( CMC ) team members and Contract Research Organizations (CROs), as well as… more
- Novo Nordisk (Lexington, MA)
- …(statistics, pharmacometrics), Research and Early Development, Global Translation, Global Medical Affairs , Global Safety (GS), Bioanalysis, CMC and occasionally ... Are you ready to make a difference The Position The Clinical Pharmacology Specialist can be accountable for the Clinical pharmacology strategy for phase 1-4 in… more
- IQVIA (Durham, NC)
- …CTL&D Specialist + Other Interfaces: Quality and Compliance Manager/ Specialist , R&D/Local Operating Company staff (including Medical Affairs ), Bioresearch ... **Overview:** The Site Investigational Product Specialist (SIPS) will serve as a subject matter...to applicable Johnson & Johnson SOPs, Wis, policies, local regulatory requirements, etc. + Co-author of the IPPI and… more
- Rush University Medical Center (Chicago, IL)
- …and coding. Certifications may include Certified Professional Coder (CPC), Certified Coding Specialist (CCS) and Certified Medical Coder ( CMC ), and any other ... communicates with Revenue Cycle colleagues, study teams, patients, Office of Research Affairs , IRB, RUMC Compliance, and all partners in the Research Continuum. *… more