- Veterans Affairs, Veterans Health Administration (Long Beach, CA)
- …of the environment of care program that meets current Joint Commission, Food and Drug Administration ( FDA ), College of American Pathologists (CAP), NFPA, and VA ... promoted to the full performance level without further competition when all regulatory , qualification, and performance requirements are met. Selection at a lower… more
- CommonSpirit Health (Santa Maria, CA)
- …research participants under the direction of the PI, and/or coordinate study drug administration with hospital/clinic Pharmacy staff. + Process labs for clinical ... the study sponsor and IRB as required by GCP, FDA , OHRP and CommonSpirit Health policy. + In conjunction...+ Prepare, manage and submit all required any required study/ regulatory , documents, applications and forms, including but not limited… more
- Cedars-Sinai (Los Angeles, CA)
- …ensures compliance with all federal and local agencies including the Food and Drug Administration ( FDA and local Institutional Review Board. **Primary Duties and ... adverse events, concomitant medication use, protocol compliance, and response to study drug . + Schedules and participates in monitoring and auditing activities. +… more
- Cedars-Sinai (Los Angeles, CA)
- …ensures compliance with all federal and local agencies including the Food and Drug Administration ( FDA and local Institutional Review Board. **_*This position is ... adverse events, concomitant medication use, protocol compliance, and response to study drug . + Schedules and participates in monitoring and auditing activities. +… more
- Gilead Sciences, Inc. (Foster City, CA)
- …translational science, biomarker strategy, and early clinical trial design. + Regulatory knowledge: Familiarity with FDA /EMA guidance for preclinical and ... Team Leads to support a diverse portfolio of small molecule and biologics drug candidates across development and commercial stages. There will be three Senior… more
- Cordis (Irvine, CA)
- …products and the successful launch of new therapies, such as our sirolimus drug -coated balloon. Additionally, you will identify trends in clinical practice and KOL ... information request about off-label products or indications + Collaborate with regulatory and compliance teams to ensure all scientific/marketing materials adhere to… more
- Sutter Health (Sacramento, CA)
- …of Homeland Security (DHS), Drug Enforcement Administration (DEA), Food and Drug Administration ( FDA ) and United States Pharmacopeia (USP). + Possess written ... stock levels, checking accuracy of pricing, and completing required regulatory documentation. Performs advanced level technician work. Exercises sound judgment… more
- ThermoFisher Scientific (San Francisco, CA)
- …cell therapy operations, commercial drug substance manufacturing, or commercial drug product manufacturing in an FDA regulated environment is required. ... Specific Information** Our Cell Therapies San Francisco site is part of the Drug Substance Division (DSD)of the Pharma Services Group (PSG). Launched in May 2023,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …The ideal candidate would also have: + Experience with CMC requirements for drug development and manufacturing of a range of product modalities. + Comprehensive ... the biopharmaceutical industry, R&D, and product commercialization, including the regulatory framework, and of global biopharmaceutical manufacturing sector and… more
- Sutter Health (Mountain View, CA)
- …of Homeland Security (DHS), Drug Enforcement Administration (DEA), Food and Drug Administration ( FDA ) and United States Pharmacopeia (USP). + Possess written ... adequate stock levels, checking accuracy of pricing, and completing required regulatory documentation. Adheres to all standards, procedures, cleaning protocols, and… more