- Cedars-Sinai (Los Angeles, CA)
- …efficiency, training of personnel, and identifying new research opportunities. Ensures compliance with all federal and local agencies including the Food and ... Drug Administration ( FDA ) and local Institutional Review Board (IRB). **What are...in patient condition, adverse events, concomitant medication use, protocol compliance , response to study drug. + Maintains accurate source… more
- BeOne Medicines (Emeryville, CA)
- …responsible for independently overseeing and conducting GCP audits, to ensure compliance with GCP regulations and industry standards, in accordance with applicable ... regulatory requirements, guidelines, laws and internally established standards and...with supporting and involvement in GCP inspections (main inspectorates ( FDA , EMA, CFDI etc.,)) and other country specific inspectorates… more
- Cedars-Sinai (CA)
- …improving efficiency, training of personnel, or identifying new research opportunities. Ensures compliance with all federal and local agencies including the Food and ... Drug Administration ( FDA ) and local Institutional Review Board (IRB). Primary Duties...in patient condition, adverse events, concomitant medication use, protocol compliance , response to study drug. + Maintains accurate source… more
- Cedars-Sinai (Beverly Hills, CA)
- …improving efficiency, training of personnel, or identifying new research opportunities. Ensures compliance with all federal and local agencies including the Food and ... Drug Administration ( FDA ) and local Institutional Review Board (IRB). **What are...in patient condition, adverse events, concomitant medication use, protocol compliance , response to study drug. + Maintains accurate source… more
- Cedars-Sinai (Los Angeles, CA)
- …research information. Presents study information at regular research staff meetings. Ensures compliance with all federal and local agencies including the Food and ... Drug Administration ( FDA ) and local Institutional Review Board (IRB). Primary Duties...in patient condition, adverse events, concomitant medication use, protocol compliance , response to study drug. + Maintains accurate source… more
- Cardinal Health (Sacramento, CA)
- …IDNs, hospitals, physician offices, etc.), strategic sourcing, marketing, regulatory / compliance and contract manufacturing. **_Responsibilities_** + Demonstrate ... collaborate with subject matter experts from other departments, especially the Legal, Regulatory Counsel and Compliance teams + Demonstrate knowledge of general… more
- Sutter Health (Sunnyvale, CA)
- …requirements with ability to optimize procurement strategies while meeting regulatory requirements + Analyze reports/processes and the administrative functions ... adequate stock levels, checking accuracy of pricing, and completing required regulatory documentation. + Addresses second-level technical and mechanical issues with… more
- UCLA Health (Los Angeles, CA)
- …Ensuring the safe and accurate completion of protocol-required procedures according to regulatory guidelines, FDA CFR, GCP, and institutional best practices is ... about protocol requirements, and emphasizing the significance of protocol compliance . The role requires maintaining all necessary documentation in accordance… more
- Gilead Sciences, Inc. (Foster City, CA)
- …development from early development to commercial launch, filing experience with FDA /EMA, and in-depth technology understanding for biological products are the key ... as an author and reviewer of CMC sections in regulatory filings, and support interactions with health agencies. +...control strategies for biologics products. + Well versed in FDA and ICH guidelines relating to registration, quality, and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …strong relationships + Understanding of the pharmaceutical payer marketing that includes FDA regulatory and legal environment (PIE, FDAMA-114, etc.) + Proven ... experience preferred + Understanding of the pharmaceutical payer marketing that includes FDA regulatory and legal environment (PIE, FDAMA-114, etc.) + Computer… more