- Sumitomo Pharma (Sacramento, CA)
- …cross-functional ad-hoc projects or assignments that require safety input, ensures compliance with regulations/internal SOPs, and fosters a culture of "Safety First" ... and risk management regulations and guidelines, including pre- and post-marketing US FDA and/or EU ICH safety requirements** + Expertise in medical review of… more
- Stryker (San Jose, CA)
- …Areas of Responsibility:** + Ensure divisional achievement of quality, regulatory, and compliance targets + Direct activities to ensure new product development and ... and objective-setting for team members + Develop best practices to ensure compliance and drive revenue through improved customer experience + Provide a platform… more
- Cedars-Sinai (Santa Monica, CA)
- …and Sponsor representatives to successfully implement research protocols, in compliance with all regulatory requirements. **Primary Duties and Responsibilities:** + ... planning, projecting resource requirements, and developing systems to ensure protocol compliance and patient safety. + Responsible for accurate and timely data… more
- Hologic (San Diego, CA)
- …quality management system and moderate/high complexity projects in support of compliance and overall Hologic continuous improvement efforts. The incumbent will ... and Collaboration: + Leads project(s) to support process improvements and compliance . + Identifies specific action steps, accountabilities and timelines for… more
- Stryker (Irvine, CA)
- …across the business and for customers while ensuring regulatory standards and compliance . **What You Will Do:** + Work closely with operations, business functions, ... onboarding materials, documentation practices, and targeted training programs focused on compliance , quality culture, and process understanding. + Mentor and oversee… more
- Ascendis Pharma (Palo Alto, CA)
- …(CAPA) as applicable. + Supports with the oversight of regulatory and departmental compliance by ensuring timely processing of ICSRs in the Safety Database and ... submission to Health Authorities or partners as applicable. + Ensure any non- compliance or late ICSR are identified and ensure deviations are filed in accordance… more
- Kelly Services (Irvine, CA)
- …developing, and testing according to established policies, procedures, government and compliance regulations, and customer requirements_ + _Build prototypes and work ... efficacious design and processes_ + _Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and… more
- Cedars-Sinai (Beverly Hills, CA)
- …teams to develop and negotiate budgets, review contracts, and ensure compliance with institutional and sponsor regulations. This position requires strong attention ... budgets, details budgets, and responsible for monitoring accounts and invoicing. Ensures compliance with all federal and local agencies including the Food and Drug… more
- Sumitomo Pharma (Sacramento, CA)
- …Summary of Efficacy (ISE) strategy for NDA/BLA submissions, ensuring compliance with regulatory expectations. + Collaborate closely with cross-functional ... Bayesian Statistics + Good understanding and working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations is a plus + Advanced proficiency… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …concept through to commercialization-with a sharp focus on scientific rigor and regulatory compliance . This new role is ideal for someone who thrives in environments ... concept through to commercialization-with a sharp focus on scientific rigor and regulatory compliance . This new role is ideal for someone who thrives in environments… more