- Abbott (Sylmar, CA)
- …solutions comply with relevant regulatory standards and collaborate with Regulatory Affairs to support submission strategies and post-market surveillance. + ... AI-based SaMD modules. Support international regulatory submissions. + Ensure AI...scientific findings, and cultivate partnerships with academia, startups, and regulatory bodies. **Qualifications** + Bachelor's degree required. Ph.D. required… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …cross-functionally with analytical team members, process chemistry, formulation development, regulatory affairs , quality assurance, and other departments to ... drug substance and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols and timelines,… more
- AbbVie (South San Francisco, CA)
- …areas of work may include clinical trials, patient safety, and global medical affairs (GMA). The Associate Director works in partnership with experts in multiple ... of a team. Lead/develop statistical strategy for project development and regulatory submission. + Provide statistical leadership for design, analysis and reporting… more
- AbbVie (Irvine, CA)
- …strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations and emerging issues. ... scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses and other program documents. Lead development,… more
- BeOne Medicines (Emeryville, CA)
- …development. This role partners closely with Clinical Pharmacology, Clinical Biomarker, Regulatory Affairs , and Clinical Development to ensure robust study ... design, insightful data analysis, and timely support for global regulatory submissions. Deep expertise in PK modeling, including non-compartmental and population PK… more
- AbbVie (South San Francisco, CA)
- …team physicians, epidemiologists, safety analysts), Statistical Programming, Clinical Statistics, Regulatory Affairs , and Medical Writing. Safety Statisticians ... + Provide strategic input on safety related submissions to regulatory agencies and responses to requests from regulatory...MS (with at least 14 years of experience) or PhD (with at least 10 years of experience) in… more
- Gilead Sciences, Inc. (Foster City, CA)
- …ensuring high-quality output and fiscal discipline. + **Collaborate cross-functionally** with Regulatory , Legal, Medical Affairs , CL&D, II&D, Global Marketing, ... and sustaining market leadership. + Advanced degree (MBA, PharmD, PhD , MD) preferred. + Deep understanding of regulatory... PhD , MD) preferred. + Deep understanding of regulatory requirements and their impact on HCP marketing. +… more
- City and County of San Francisco (San Francisco, CA)
- …Managed Care (eg, Office of Coordinated Care, Quality Management, Utilization Management, Regulatory Affairs ). Core responsibilities of the Assistant Director of ... Center, and over 15 primary care health centers. The Population Health Division ( PHD ) provides core public health services for the City and County of San… more
- Abbott (Pleasanton, CA)
- …work closely with cross-functional peers in quality, operation, marketing, clinical and regulatory , medical affairs , commercials to define an aligned and ... protected. + Interfaces with appropriate internal and external resources ( regulatory , customers, etc.) to ensure development programs meet regulatory… more
- AbbVie (Irvine, CA)
- …opinion leader interactions related to the disease area(s); partners with Medical Affairs , Commercial and other functions in these activities as required, consistent ... strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations and emerging issues.… more