- IQVIA (Raleigh, NC)
- …(samples, promotional and educational materials) to maximize return within regulatory and ethical guidelines. + Maintains accountability for all pharmaceutical ... samples in accordance with FDA and PDMA guidelines. + Utilize the sales automation system to document call and program activity. + Complete initial and ongoing… more
- Belcan (Sanford, NC)
- …suppliers/contractors to ensure compliance with local and global quality standards, regulatory requirements, and industry guidance. * Provide QA review and approval ... utilities, automation, sterile filling, and clean facilities. * Strong understanding of FDA , EMA, local regulations and guidelines, ICH guidelines, and industry best… more
- University of North Carolina- Chapel Hill (Chapel Hill, NC)
- …Word. In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; ie Good Clinical Practice ( GCP ), Food and Drug ... Administration ( FDA ) regulations and International Conference on Harmonization ( ICH ) guidelines. Previous experience in hospital-based clinical trials required.… more
- Norstella (Raleigh, NC)
- …and biotech companies around the world, along with regulators like the FDA , and payers. By providing critical proprietary data supporting AI-driven workflows, ... and education materials regarding benefits offerings, wellness programs, and regulatory requirements (eg, ACA, HIPAA, ERISA). + Collaborate with Payroll,… more
- Veterans Affairs, Veterans Health Administration (Durham, NC)
- …care program that meets current Joint Commission, Food and Drug Administration ( FDA ), College of American Pathologists (CAP), NFPA, and VA requirements, particularly ... in the healthcare environment. Knowledge of healthcare industry standards and related regulatory agency and organization (including, but not limited to The Joint… more
- ThermoFisher Scientific (Raleigh, NC)
- …Ensure platform compliance with healthcare regulations including HIPAA, CLIA, IVDR, FDA , and GLP. + Work cross-functionally with product management, R&D, Commercial, ... and Regulatory teams to align platform capabilities with business objectives. + Contribute to platform roadmaps, achievements, and ongoing improvement efforts.… more
- Pfizer (Rocky Mount, NC)
- …and medical devices. + Working knowledge of Food and Drug Administration ( FDA ) Regulations/Guidance, and Good Manufacturing Practices (GMP). + Ability to work both ... public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses… more
- Catalent Pharma Solutions (Greenville, NC)
- …+ Compile and maintain all information and document relevant to all work under FDA guidelines. + Other duties as assigned. **The Candidate** + Associate degree in ... other specifications. + Good understanding of cGMPs, industry and regulatory standards and guidelines. + Goodunderstandingoffederalandlocalregulationsregardinghealthandsafetywithinmanufacturingand packaging environments. +… more
- United Therapeutics (Research Triangle Park, NC)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... products in accordance with ICH Good Clinical Practice (GCP), applicable regulatory guidelines and company standard operating procedures (SOPs). Will support… more
- BD (Becton, Dickinson and Company) (Mebane, NC)
- …Review:** Performtimelyandaccuratereview of batch records to ensure compliance with regulatory and internal standards. + **Label Printing:** Manage label printing ... such as MS Office (Word, Excel and Power Point). + Knowledge of GMP, FDA , ISO and OSHA requirements. At BD, we prioritize on-site collaboration because we believe… more