- Lundbeck (Ontario, CA)
- … Environment/ Compliance ** - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to ... policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. **REQUIRED EDUCATION, EXPERIENCE and SKILLS:** + Bachelor… more
- Gilead Sciences, Inc. (La Verne, CA)
- …Oversight:** + Ensure product transfer team can deliver products to meet compliance with regulatory requirements, Current Good Manufacturing Practices (cGMPs), ... Packaging, Quality Assurance (QA), Quality Control (QC), Validation, Supply Chain, Regulatory /CMC, EHS, Finance, IT, and Engineering. **Project Team Management:** +… more
- Gilead Sciences, Inc. (Foster City, CA)
- …for informed business decisions and outcomes. + Strong understanding of pharmaceutical compliance regulations for Meetings, Congresses, M&E Technology solutions ... US Commercial, Technology & Data Insights, focusing on capabilities, compliance , operational efficiency, technology innovation, data driven insights supporting… more
- Pfizer (San Francisco, CA)
- …is up-to-date and integrated into key commercial systems. + **Data Accuracy and Compliance ** : Ensure that all data management processes comply with regulatory ... processes, ensuring smooth transitions and adoption by relevant teams. ** Compliance and Data Security** + **Data Compliance **...** : Ensure oncology data management processes adhere to regulatory guidelines such as HIPAA, GDPR, and other data… more
- Astrix Technology (Los Angeles, CA)
- …Practices (cGDP) throughout all document processing and handling activities. + Ensure compliance with regulatory standards for pharmaceutical and technical ... properly documented, accurate, and compliant with internal policies and regulatory requirements. **Key Responsibilities** + Transcribe information from physical… more
- Cedars-Sinai (Beverly Hills, CA)
- …best practice care delivery, collaborating with other healthcare team members. + ** Regulatory Compliance :** Utilize knowledge of regulating agencies (FDA, USP, ... etc.), best practice standards, and institutional policies and procedures to maintain regulatory compliance . + **Education and Training:** Participate in the… more
- Merck (Sacramento, CA)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... tools and framework for driving Go/No Go decisions on programs and rapid regulatory approvals + Foster collaboration within QP2 to achieve results, remove barriers… more
- Merck (San Francisco, CA)
- …size and survival. A + Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology, authoring ... regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs),...required:** + Ph.D. with at least seven years of pharmaceutical drug development experience relating to: PKPD, pharmacometrics, mathematics,… more
- Merck (South San Francisco, CA)
- …record of increasing responsibility and independence in a similar role in pharmaceutical drug development, regulatory agency, or academia. + Educational ... external vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug discovery and… more
- Cytel (Sacramento, CA)
- …and a strong understanding of statistical programming within a biotech or pharmaceutical environment. The ideal candidate will contribute to the maintenance of ... Listings, and Figures (TLFs) using SAS. Familiarity with GxP standards for regulatory submissions is essential. + Develop and maintain open-source software platforms… more