- Fujifilm (Holly Springs, NC)
- …QC Chemistry ensures GMP-compliant laboratory operations in accordance with regulatory guidelines. This role performs technical/compliance reviews and approves ... North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …R, etc.** + Excellent working knowledge of phase I clinical operations, drug development, multi-region regulatory requirements. + Good working knowledge of ... **pharmacometrics** activities related to pre-IND, IND, phase1-3, PK, PK/PD and regulatory submissions. You will conduct analysis, execution and reporting of… more
- GE Vernova (Wilmington, NC)
- …delivery of equipment packages and engineering documentation in accordance with contract requirements, business procedures, and regulatory agency guidelines ... internal and external customers, suppliers, partners, the NRC and international regulatory authorities on technical issues. + Incorporate design requirements into… more
- Cambrex High Point (Durham, NC)
- …global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire ... analytical support, such as release and stability testing of drug substances and drug products. Able to...+ Responsible for ensuring compliance with cGMP and other regulatory guidelines. + Analyze information for technical correctness and… more
- ThermoFisher Scientific (Greenville, NC)
- …softgel drug products from development to commercialization. As the Contract Development Manufacturing Organization (CDMO) market leader, we have built a ... **Environmental Conditions** Office **Job Description** **Location/Division Specific Information** The Drug Product Division (DPD) is one of the three divisions… more
- Wells Fargo (Charlotte, NC)
- …and technology teams, specializing in vendor relationship management and carrier contract negotiation. This role leads and contributes to technology initiatives that ... years proven experience in technology business systems consulting, vendor management, and contract negotiation. + 5+ years' experience specifically in voice and data… more
- Cambrex High Point (Durham, NC)
- …global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire ... analytical support, such as release and stability testing of drug substances and drug products. Able to...+ Responsible for ensuring compliance with cGMP and other regulatory guidelines. + Analyze information for technical correctness and… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …trial and submission support, lead the R&D audit program, engage with regulatory authorities, and maintain clinical data integrity. The leader will be responsible ... audits at all relevant facilities, investigator sites, and vendors (including contract research organizations) and ensure that audit results are communicated, and… more
- WSP USA (Raleigh, NC)
- …expenses, ensuring profitability and satisfactory performance, and supervising subcontractors, contract work, and employees. + Responsible for the contribution and ... with applicable Federal, State, and Local Agency laws, policies, and regulatory requirements. + Support the overall long-term strategy, growth, and pipeline… more
- Prime Therapeutics (Raleigh, NC)
- …of network contracts, participation requirements, analysis of pharmacies, and ensuring contract and regulatory compliance. This position is accountable for ... fee schedule revisions align with Supply Chains COGS strategies for specialty drug management + Lead and implement network initiatives by facilitating and performing… more
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