- Organon & Co. (Plymouth Meeting, PA)
- …of industry experience in R&D functions (eg, Clinical Research, Early Development, Medical Affairs , Pharmacovigilance, Regulatory Affairs , etc.) + At least ... three years of experience in project management. + Proficient with MS Project, MS Timeline, and all Office products. + A working understanding of and application of principles, concepts, practices, and standards of pharmaceutical project management. + Worked… more
- Sanofi Group (Swiftwater, PA)
- …with colleagues mainly from PSPV as well as Pre-Clinical & Clinical Development, Regulatory Affairs , Medical Affairs , Legal and Global Business Units ... + Provides safety expertise, disease and patient knowledge for assigned products in terms of benefit-risk assessments, and risk management (incl. risk minimization measures) **About You** **Experience:** + Excellent clinical judgment + Capability to synthesize… more
- Belcan (Indianola, PA)
- …team consisting of a broad range of subject matter experts from R&D, Quality, Regulatory , Medical Affairs , Sales and Marketing and Product Supply. This position ... industry. Key Work Relations . Internal: Collaborate with R&D, Quality, Regulatory , Medical Affairs , Sales and Marketing and Product Supply and others. .… more
- Highmark Health (Harrisburg, PA)
- …position serves as a key liaison between Claims Operations, Customer Service, Regulatory Affairs , IT, Legal and other departments, proactively identifying, ... assessing, and mitigating compliance risks. The Analyst will monitor regulatory changes, interpret their impact on operational processes, and implement effective… more
- Merck (North Wales, PA)
- …will work collaboratively with other leaders in Clinical Development and Global Regulatory Affairs . The AVP provides leadership and direction through ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Kelly Services (Malvern, PA)
- …analysis. + Coordinate data collection and trend analysis as requested by QA and Regulatory Affairs including the annual report required for maintenance of the ... to assist with change control, equipment startup, and technical training, assuring regulatory compliance and technical feasibility of proposed changes. + Serve as… more
- Cytel (Harrisburg, PA)
- …with cross-functional teams, including analytical scientists, process engineers, and regulatory affairs , to develop and implement appropriate statistical ... complex manufacturing data to ensure product quality, consistency, and regulatory compliance. **As a Principal Biostatistician, your responsibilities will include:**… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …appropriate. + Collaborate with cross-functional teams including R&D, Quality Assurance, Regulatory Affairs , and Operations to align strategies and optimize ... process validation lifecycle (PPQ, CPV, etc.) ensuring compliance with global regulatory standards. + Establish and oversee robust Continued Process Verification… more
- Glenmark Pharmaceuticals Inc., USA (Allentown, PA)
- …Quality Reporting System) cases, coordinating with manufacturing sites for investigation and Regulatory Affairs for arranging more information/ samples from FDA. ... or more GXPs, in-depth knowledge of EU and US FDA regulatory standards, knowledge of regulatory standards in other counties desirable Knowledge and Skills +… more
- KPH Healthcare Services, Inc. (Latrobe, PA)
- …to provide improved efficiencies, profitability, and customer service. + Responsible for all regulatory affairs as it pertains to pharmacy to ensure all ... locations are operating within state, federal and other regulatory guidelines, and corporate policies are adhered to + Responsible for the monitoring of bench… more