- Gilead Sciences, Inc. (Foster City, CA)
- …healthcare compliance . + Experience with the following is preferred: pharmaceutical regulations; compliance frameworks; industry standards; drug pricing (eg, ... aligned with the company's US and global objectives, industry dynamics, regulatory landscape, and other external dynamics. + Lead, inspire, role-model, manage,… more
- Cedars-Sinai (Los Angeles, CA)
- … staff, and Sponsor representatives to successfully implement research protocols, in compliance with all applicable regulatory requirements. + Establishes and ... entry and reporting, including resolution of queries from sponsors or regulatory entities. + Coordinates institutional, pharmaceutical and internal audits,… more
- Cedars-Sinai (CA)
- … staff, and Sponsor representatives to successfully implement research protocols, in compliance with all applicable regulatory requirements. **Primary Duties and ... entry and reporting, including resolution of queries from sponsors or regulatory entities. + Coordinates institutional, pharmaceutical and internal audits,… more
- Element Materials Technology (Concord, CA)
- …customer expectations at Element Concord. The Manager's main duties are to ensure compliance and accuracy when reporting results to clients. The Manager must provide ... services that adhere to the quality management system, client requirements, and regulatory requirements as applicable ie ISO/IEC 17025:2017, USP, GMP, FDA, and ICH… more
- Gilead Sciences, Inc. (Foster City, CA)
- …of clinical trial protocols for inflammation programs, ensuring scientific rigor and regulatory compliance . + Serve as the clinical lead on cross-functional ... key role in shaping clinical strategy, collaborating cross-functionally with research, regulatory , safety, and commercial teams to advance innovative therapies that… more
- AbbVie (South San Francisco, CA)
- …regulatory agencies as needed. Validate external statistical software to ensure compliance with SOPs and regulatory requirements. Significant Work Activities: ... of a team. Lead/develop statistical strategy for project development and regulatory submission. + Provide statistical leadership for design, analysis and reporting… more
- Amgen (Thousand Oaks, CA)
- …responsibilities include:** + Implement global environmental management systems to assure compliance with all country, state, and local regulatory requirements ... role will work with an empowered team to lead global environmental compliance management programs and support the development of innovative and compliant solutions.… more
- AbbVie (Irvine, CA)
- …+ Based on strong medical and scientific experience, knowledge of compliance and regulatory requirements, Allergan Aesthetics customers, markets, business ... industry, academia, or equivalent. + Knowledge of clinical trial methodology, regulatory and compliance requirements in Aesthetic Medicine. + Ability to… more
- AbbVie (Irvine, CA)
- …plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations ... scientific and business strategy. *Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and… more
- Grifols Shared Services North America, Inc (San Diego, CA)
- …Edit and maintain technical documentation including operator manuals, package inserts, and regulatory submission documents in compliance with regulatory ... and company standards + Edit documents to support Labeling Development in compliance with ISO, cGMP, EU MDR and FDA guidelines, working within established… more