- Sanofi Group (Swiftwater, PA)
- …with US FDA and EMA. Supports strategic negotiations with worldwide Regulatory Health Authorities so that appropriate and pragmatic positions are negotiated with ... of medicine? The race is on to speed up drug discovery and development to find answers for patients...Ready to get started? **Main Responsibilities:** + Develop global regulatory CMC strategies and risk assessments for development projects… 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
- Charles River Laboratories (Wayne, PA)
- …We have proudly worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits ... worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on… more
- Merck (West Point, PA)
- **Job Description** **Join Our Team as a Biologics** ** Drug Substance & Cell Banking Leader** **!** Are you ready to take your career to the next level? We are ... seeking a dynamic and visionary Biologics Drug Substance & Cell Banking Leader to spearhead our...DS & cell banking process development, process characterization and regulatory filing activities to ensure a smooth and clear… 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, second… more
- Envista Holdings Corporation (Quakertown, PA)
- …activities. + Ensure that the company's products comply with the US Food and Drug Administration ( FDA ), local and state agencies and global health authority and ... growing, energetic, and diverse mix of professionals spanning engineering, operations, regulatory and quality backgrounds that work collaboratively in the fast-paced… more
- West Pharmaceutical Services (Exton, PA)
- …within the ERP Services Delivery model, West policies, and procedures as well as regulatory requirements including but not limited to Sarbanes-Oxley and FDA GMP. ... ERP-SAP S4 Hana Services Delivery model, West policies and procedures as well as Regulatory requirements including but not limited to Sarbanes-Oxley and FDA GMP.… more
- MTF (Olyphant, PA)
- …MTF's quality assurance standards and compliance with ISO, AATB, TGA and FDA regulations. Maintain raw material and post-irradiated material inventory to prevent ... using aseptic techniques according to specified work order and regulatory requirements. 2. Aseptically transfer completed work orders to...and is in compliance with ISO, AATB, TGA and FDA regulations. 7. Execute transactions in QAD to ensure… more
- Geisinger (Danville, PA)
- …recommends improvements for dosimetry or image quality. + Supports inspections/audits from regulatory /recommending bodies including TJC, PA DEP, FDA , ACR, and ... meets the American College of Radiology (ACR) and United States Food and Drug Administration ( FDA ) definition of a qualified medical physicist (QMP).… more
- WellSpan Health (York, PA)
- …and ad hoc reports, as required by investigators, management, sponsors, and/or regulatory bodies. Ensures billing of study procedures to the appropriate funding ... and informed consent documentation requirements are met as per the GCP, FDA and IRB guidelines. Registers and accomplishes randomization of patients enrolled in… more