- Veterans Affairs, Veterans Health Administration (Philadelphia, PA)
- …The Joint Commission (TJC), National Fire Protection Association (NFPA), Food and Drug Administration ( FDA ), Nuclear Regulatory Commission (NRC), Association ... Knowledge of standards including National Fire Protection Association (NFPA), Food and Drug Administration ( FDA ), the Joint Commission (TJC), and the Association… more
- Merck (West Point, PA)
- …As part of Our Company's Manufacturing Division, within the Vaccines Drug Substance Commercialization (VDSC), the Upstream department provides the technical process ... commercial manufacturing processes for the upstream portion of vaccines drug substance processes. VDSC supports various commercialization activities, early and… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …study design and complex analysis issues, FDA issues, and general drug development. + Reviews clinical, statistical, and regulatory literature for current ... values and will be responsible for providing statistical expertise/input in the drug development including clinical development plan and regulatory submission… more
- West Pharmaceutical Services (Williamsport, PA)
- …processes related to the manufacture of West products. Ensure compliance with regulatory requirements and West procedures. Proactively develop, lead, and drive the ... quality assurance plans ensuring compliance with regulations, oversee interactions with regulatory agencies and build strong relationships with internal and external… more
- Merck (West Point, PA)
- …degree is preferred. + Leadership experience with working knowledge of device, biologic/ drug product, and process development including regulatory submission and ... & Process Development (DPPD) Team designs, develops, and commercializes novel biologic/ drug /vaccine - device enabled combination products to achieve safe and… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …approaches. + Ensure training content is accurate, current, and aligned with global regulatory requirements ( FDA , EMA, ICH). **Compliance & Risk Management** + ... and managing cross-functional teams. + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA , EMA, etc.). + Proven ability to… more
- J&J Family of Companies (Spring House, PA)
- … regulatory submission documents that summarize toxicology, safety pharmacology, drug metabolism, and pharmacokinetics studies. This role will collaborate closely ... pharmacokinetic (PK) and discovery biology project leads, medical writers, global regulatory dossier leaders, and other subject matter experts (SMEs) to drive… more
- Merck (North Wales, PA)
- …and quality management of submission data standard deliverables for world-wide regulatory application submissions of drug and vaccine clinical development ... questions for FDA edata mailboxes (CBER/CDER), attendance at meetings with regulatory agencies ( FDA , EMA, PMDA). + Guide project teams preparing submission… more
- University of Pennsylvania (Philadelphia, PA)
- …reporting requirements of all external review organizations, most notably the Food and Drug Administration ( FDA ). In addition to clinical trial management, the ... reporting requirements of all external review organizations, most notably the Food and Drug Administration ( FDA ). In addition to clinical trial management, the… more
- University of Pennsylvania (Philadelphia, PA)
- …comply with all policies relating to the University of Pennsylvania, Penn Medicine, FDA , GCP and other regulatory standards. The Clinical Research Coordinator ... research investigators, Research Team Leaders, our clinical research nurse(s), and regulatory coordinator. The ACC received an exceptional rating from the National… more