- Sanofi Group (Swiftwater, PA)
- …Manufacturing and Supply network (eg procurement, supply chain, finance) to ensure compliance with internal and regulatory requirements, and to disposition ... LM GenMed. This individual provides strategic leadership, direction, and oversight for compliance and risk management programs and is responsible for fostering a… more
- Merck (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... data + Produce tables and graphics for inclusion in study reports and regulatory submissions + Ensure programmatic traceability from data source to modeling result +… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …This role is responsible for ensuring the robustness, scalability, and compliance of upstream operations through effective technology transfer, validation support, ... and/or review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to upstream processing. +… more
- Sanofi Group (Swiftwater, PA)
- …product team to meet goals and priorities. Assures operations are conducted in compliance with regulatory authorities. Assures operations are conducted in ... compliance with cGMPs, CBER, WHO, EP and other regulatory bodies. Plans and initiates the overall production schedules...experience in working with a production department of a pharmaceutical company. + Experience in FDA Regulated Industry +… more
- Prime Therapeutics (Harrisburg, PA)
- …Clinical Program Management, Utilization Management (UM), Formulary, GuidedHealth, Pharmaceutical Trade Relations, Pharmacy Audit, Clinical Operations and/or ... client and internal program reporting, which may include UM Savings, Compliance , Utilization data, Retrospective Drug Utilization Review (DUR), Concurrent DUR,… more
- Sanofi Group (Swiftwater, PA)
- …in quality assurance activities (Gemba walks, filter testing)** **Ensure compliance with cGMP and documentation requirements** **Manage production processes and ... + Serve as point of contact for training initiatives, regulatory audits, and change control + Complete Gemba walks...with 2+ years of experience in a cGMP or pharmaceutical manufacturing environment + Or Associate degree with 1+… more
- Guidehouse (Philadelphia, PA)
- …all levels, to deliver product planning, pricing, reimbursement, product commercialization, and regulatory and compliance solutions. Do you think you are up ... Guidehouse's Life Sciences practice is an engine of innovation, helping pharmaceutical , biotech, medical device, and diagnostic companies develop custom solutions… more
- Guidehouse (Philadelphia, PA)
- …all levels, to deliver product planning, pricing, reimbursement, product commercialization, and regulatory and compliance solutions. Do you think you are up ... Guidehouse's Life Sciences practice is an engine of innovation, helping pharmaceutical , biotech, medical device, and diagnostic companies develop custom solutions… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …and advocates for Otsuka prominence in CNS space + Provides input into regulatory documents, including product labeling + Accountable for resourcing of personnel and ... that the medical strategy function operates effectively and efficiently Ensures compliance with all relevant Corporate Policies (CO) and Standard Operating… more
- University of Pennsylvania (Philadelphia, PA)
- …and reports directly to the Associate Director, PSOM Office of Clinical Research Compliance . The Clinical Quality Specialist will work as part of the Compliance ... will work with senior team members to facilitate and conduct high quality compliance reviews, which include review preparation, conduct, close out and reporting, to… more