- BeOne Medicines (San Mateo, CA)
- …taken when recalls or product complaints arise during product lifecycle for the assigned project . + Provide CMC regulatory review for clinical protocols and ... regulatory strategies as well as authoring CTD CMC sections for the assigned project to...is a plus. + Demonstrated leadership as a people manager . + Experience in authoring complex technical documents, CTD… more
- Cardinal Health (Sacramento, CA)
- …systems and contributes to reports and presentations for clients. May serve as a project manager for smaller projects and ensure that team members achieve ... **_What Chemistry, Manufacturing & Control ( CMC ) contributes to Cardinal Health_** The _Scientist I,...of experienced Scientists, learns variety of internal, client, and regulatory systems and develop authoring and project … more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units ... associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external...needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling,… more
- AbbVie (Irvine, CA)
- …(TPP), Asset Plan and PDP, tracking progress in conjunction with the Portfolio Project Manager , with attention to committed timeline and budget. + Ensures ... brands (Development, Discovery, Development Sciences, Operations, Commercial, Market Access, Regulatory , Safety, Project Management, Medical Affairs, etc., and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Senior Director, Product Management Team Lead (Early Phase) will have experience serving as project manager for early phase biopharma molecules and will serve as ... **KEY RESPONSIBILITIES** Reporting to the Executive Director of Product & Project Management and operating within the broader Pharmaceutical Development and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Support or represent function and work collaboratively on cross-functional teams to support project team strategy and regulatory filings. . Fully embrace a ... documentation practices. . Author technical documents such as protocols, reports, regulatory dossier, etc. and prepare data-focused presentations for internal and… more
- Astrix Technology (San Diego, CA)
- …and day-to-day operations within the QC department + Report directly to the CMC Expert Manager **Qualifications:** + Master's degree in Chemistry (Bac+5); ... technical documentation + Perform analytical data review to ensure compliance with regulatory and quality standards + Manage and execute stability studies + Support… more