- Astellas Pharma (Northbrook, IL)
- **Medical Affairs Global Strategic Brand Lead, Precision Medicine** Do you want to be part of an inclusive team that works to develop innovative therapies for ... in remote work are encouraged to apply. **Purpose and Scope:** The Medical Affairs Global Strategic Brand Lead (MA GSBL) Precision Medicine (PM) is accountable for… more
- University of Washington (Seattle, WA)
- …program SOPs, policies, GCP and FDA regulations. The QA procedures include regulatory and clinical compliance reviews of trial activities such as source ... groups integral to the successful completion of research projects. * Oversee regulatory affairs coordination as outlined by protocol objectives. This includes… more
- Astellas Pharma (Northbrook, IL)
- …team meetings, influencing decisions with rigorous statistical insight. + Collaborate with Clinical Development, Medical Affairs , Regulatory , Market Access, ... team supporting evidence generation and decision-making, with responsibility spanning clinical trial statistics, exploratory statistics, medical affairs … more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …Department, Marketing, Sales, Research and Development, strategy/portfolio management, Regulatory Affairs , and Pharmacovigilance. External collaboration includes ... Functions + Possesses deep specialty/scientific knowledge and in-depth knowledge of medical affairs and clinical development within the Rheumatology specialty. +… more
- Cardinal Health (Albany, NY)
- …and performing investigator-initiated research of NPHS products + Collaborate with NPHS Clinical Affairs to enhance patient enrollment in NPHS-sponsored ... medical affairs professionals who report to the Sr Director of Regulatory & Medical Affairs . **Responsibilities:** + Collaborate across multiple functions… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …papers, and literature reviews). The Analyst III requires a thorough understanding of FDA regulatory requirements for complaint handling and MDR reporting per ... team member/ leader, in fulfilment of corporate objectives for FDA regulatory compliance. Performs routine assignments independently;...Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs … more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …and competitors as well as a general understanding of important topics including clinical trial design, drug development, regulatory decision making and public ... most senior communications advisor to leaders in Commercial and Brand, Medical Affairs , Clinical Development and Portfolio Strategy regarding strategic TA,… more
- University of Colorado (Aurora, CO)
- …experience. + Two (2) - four (4) years of related quality assurance and regulatory affairs experience in a clinical laboratory. + MT(ASCP) or ... | Department of Medicine | Division of Allergy and Clinical Immunology | ClinImmune | The Center for ...through audits and occurrence reports to the Director of Regulatory Affairs and/or Quality Manager, which are… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …Pharmacy, or related fields, required. + 10+ years of relevant experience in regulatory affairs , compliance, or quality assurance in the pharmaceutical, biotech, ... Director of Inspection Readiness is responsible for ensuring organizational preparedness for regulatory agency inspections (eg, FDA , EMA, PMDA, etc.) across… more
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- … Clinical Affairs Lab Operations team. This role contributes to regulatory submissions (eg, FDA and global agencies) by executing molecular and ... with no direct or indirect supervisory responsibilities. The role operates within the Clinical Affairs Lab Operations team and is accountable for executing… more