- Stanford University (Stanford, CA)
- …leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions, and respond to requests and questions. + ... milestones, and invoice sponsors according to study contract. + Ensure regulatory compliance. Regularly inspect study document to ensure ongoing regulatory… more
- BeOne Medicines (Emeryville, CA)
- …and non-medical functions (eg, Marketing, Market Access, HEOR, Legal, Compliance, Regulatory , etc.). This position will also assist with program management, ... and tracking of IITs, EAPs, Phase IV studies and create the structure for review of post-hoc analysis requests. This is a Remote-based position with direct reports.… more
- Boehringer Ingelheim (Fremont, CA)
- …the different phases of the supplier life cycle (eg, audits). + Generation, review , negotiation and maintenance of Quality Assurance Agreements with CMOs, CLOs and ... person, first escalation point and source of quality guidance (eg, material review board decision-making) to resolve quality issues triggered by interactions with… more
- Bristol Myers Squibb (San Diego, CA)
- …may be a member of the Clinical Development Team (CDT) + Conducts medical data review of trial data, including eligibility review + Holds responsibility for site ... disease area and relevant science in order to meet regulatory and disease strategy targets + Provides oversight and...the disease area by attending scientific conferences and ongoing review of the literature + Keep s abreast of… more
- Safran (Irvine, CA)
- …Identify and analyze potential failure modes and recommend design improvements. Review customer specifications and statement of work to ensure overall technical ... products and modify existing products to support customer, manufacturing, regulatory , industry standard, and market requirements. Provide technical support, interact… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …aspects of upstream process technology transfers to CDMOs, including documentation review , gap analysis, and risk assessment. + Provide expert technical oversight ... of upstream manufacturing operations at CDMOs, including review of batch records, deviation investigations, and change controls. + Lead or significantly contribute… more
- Veterans Affairs, Veterans Health Administration (Los Angeles, CA)
- …outpatient records. Inpatient duties consist of the performance of a comprehensive review of documentation within the health record to assign ICD-10-CM and ... of DRGs. Outpatient duties consist of the performance of a comprehensive review of documentation within the health record to accurately assign ICD-10-CM codes… more
- Stantec (Sacramento, CA)
- …and water-related nature-based solutions in California's complex political, regulatory , and ecological environment. Candidates must have California water ... have strong federal, state, and local water agency client networks, regulatory agency relationships, expertise in the Sacramento-San Joaquin River Delta (preferred),… more
- Abbott (Alameda, CA)
- …responsible for maintaining comprehensive research documentation for audits, inspections and regulatory submissions. Develop and/or conduct the continuous review ... risk review meetings between functional groups, completing risk management review reports and ensuring execution of actionable items, guide the monitoring and… more
- Carollo Engineers (Walnut Creek, CA)
- …to join our team. This role is critical in providing comprehensive contract review and risk analysis beyond standard policy checklists. The ideal candidate will come ... are looking for someone who is proactive, solutions-oriented, and can confidently review contracts with a critical eye, identify red flags, and recommend thoughtful… more