- BeOne Medicines (Emeryville, CA)
- …role (as Lead or Co-auditor) who is responsible for independently overseeing and conducting GCP audits, to ensure compliance with GCP regulations and ... Audit : Perform on-site or remote audits (routine, for-cause/directed); Evaluate compliance with GCP regulations, internal quality standards, and relevant… more
- ASM Research, An Accenture Federal Services Company (Sacramento, CA)
- …firewall & reverse web proxy, and overall network security). + Perform logging within the GCP environment in compliance with DLA RMF and Audit Log SOP, and ... **Telecommunications Network Engineer** Google Cloud Platform ( GCP ) Cloud Telecommunications Network Engineer supporting day-to-day support of GCP architecture… more
- Ascendis Pharma (Palo Alto, CA)
- …and supporting implementation of CAPAs as necessary + Work Closely with Ascendis GCP /PV Compliance team and Commercial organization as required to ensure ... discuss new MAP-related processes. + Through coordination with Ascendis GCP and PV Compliance team will provide...Through coordination with Ascendis GCP and PV Compliance team will provide appropriate representation during PV related… more
- Terumo Neuro (Aliso Viejo, CA)
- …and FDA regulations. Job duties: + Develop and implement SOPs to ensure GCP /ICH compliance for data management, database operations, clinical report writing, ... Audit data management vendors, as appropriate. + Assure regulatory compliance of vendors with company SOPs, FDA and ICH...skills, ability to coach and mentor. 4. Knowledgeable in GCP standards, FDA and ICH guidelines, and recommended CDM… more
- Gilead Sciences, Inc. (Foster City, CA)
- …for the successful oversight and completion of a broad spectrum of GCP audit activities and deliverables across large sites, countries, or multiple regions. ... as a primary point-of-contact to assigned R&D groups and advise on: GCP regulatory requirements; relevant Gilead policies and procedures supporting audits and… more
- Ascendis Pharma (Palo Alto, CA)
- …activities may include but are not limited to: + Through coordination with Ascendis GCP and PV Compliance team will provide appropriate representation during PV ... in the safety database and are reported according to ICH- GCP guidelines, Healthy Authority regulations and company SOPs, Work...+ Supports with the oversight of regulatory and departmental compliance by ensuring timely processing of ICSRs in the… more
- Ascendis Pharma (Palo Alto, CA)
- …Ascendis Pharmacovigilance System Master File (PSMF) + Through coordination with Ascendis GCP and PV Compliance team will provide appropriate representation ... are processed in the safety database and are reported according to ICH- GCP guidelines, Healthy Authority regulations and company SOPs, Work Instructions and Business… more
- Ascendis Pharma (Palo Alto, CA)
- …proactive surveillance of products in development. . Through coordination with Ascendis GCP and PV Compliance team will provide appropriate representation during ... Science for patient safety and pharmacovigilance activities for ensuring corporate compliance with all applicable laws and regulations and as appropriate, local… more
- Google (Sunnyvale, CA)
- …of Public Cloud services, with a focus on Google Cloud Platform ( GCP ). Google's software engineers develop the next-generation technologies that change how billions ... offering seamless scalability, built-in reliability, enhanced security, and consistent compliance governance. Google Cloud accelerates every organization's ability to… more
- Bristol Myers Squibb (San Diego, CA)
- …(input on inclusion/exclusion and other safety-related clinical considerations) + Fulfills GCP and compliance obligations for clinical conduct and maintains ... all required training Clinical D evelopment E xpertise & S trategy + In collaboration with the Clinical Development Lead, designs and develops clinical plans and protocols with a strong strategic focus based on knowledge of asset/drug, disease area and… more