- Stanford University (Stanford, CA)
- …regulatory compliance. + Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure ... and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. + Knowledge… more
- Stanford University (Stanford, CA)
- …regulatory compliance. + Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure ... and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. + Knowledge… more
- Abbott (Sylmar, CA)
- …and other regulatory requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, ... from varied disciplines including Clinical Medicine, Engineering, Marketing and Regulatory Affairs required. + Strong knowledge of defined development process… more
- Ascendis Pharma (Palo Alto, CA)
- …(Argus preferred) + Experience with MedDRA coding and global safety reporting regulatory requirements. + Expert knowledge of FDA safety regulations, ICH ... our core values of Patients, Science, and Passion, we use our TransCon(R) drug development platform to fulfill our mission of developing new and potentially… more
- Abbott (Sylmar, CA)
- …(EMS), and other regulatory requirements. Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company ... The demonstrated ability to understand and comply with applicable Food & Drug Administration ( FDA ) regulations and Company operating procedures, processes,… 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. Maintains research ... field with groundbreaking, life-saving research. From genetic counseling and targeted drug therapies to a growing array of minimally invasive procedures,… more
- BeOne Medicines (Emeryville, CA)
- …driving strategies, programs, and external engagement + Understanding of the prescription drug regulatory environment and clinical trial submission process in ... representative patient enrollment. This role collaborates across Clinical Operations, Regulatory , Development, and corporate functions to embed diversity into study… more
- Kelly Services (Irvine, CA)
- …and finished products. + Develop and validate stability-indicating analytical methods for drug products in accordance with USP and regulatory guidelines. + ... company in Irvine, CA. If you're passionate about advancing drug product development and mentoring others in a dynamic,...forms. + Knowledge of **cGMP** , **USP** , and ** FDA ** regulatory requirements. + Experience preparing CMC… more
- Sutter Health (Berkeley, CA)
- …billing, pricing, record keeping, and provision of services required to meet regulatory requirements. Maintains records of drug distribution and works with ... of Homeland Security (DHS), Drug Enforcement Administration (DEA), Food and Drug Administration ( FDA ), and United States Pharmacopeia (USP). Possess written… more
- Sutter Health (Novato, CA)
- …billing, pricing, record keeping, and provision of services required to meet regulatory requirements. + Maintains records of drug distribution, works with ... of Homeland Security (DHS), Drug Enforcement Administration (DEA), Food and Drug Administration ( FDA ) and United States Pharmacopeia (USP). + Possess written… more