- Sumitomo Pharma (Sacramento, CA)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director , Commercial Data Management** . This high impact role ... confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and procedures, by ensuring that all… more
- AbbVie (Irvine, CA)
- …analytical method transfer/optimization/validation, product characterization, regulatory submission, and continuous improvement for ... join us as a Group Leader based in Irvine, CA reporting to the Director , PDS&T Toxins. Responsibilities: + Manage the protein characterization group by working with… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …to drive alignment of labeling content and strategy. + Partner with Global Regulatory Affairs to ensure that all labeling is aligned with the product global ... all global labeling components. + Represent Global Labeling on product-specific Regulatory and Cross-Functional teams, as appropriate. + Collaborate with global… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …of possible** with us. As a strategic partner reporting to the Sr Director of Global Integrated Supply Chain (ISC), you'll connect platform teams with manufacturing ... **Skills** + Advanced knowledge in operational excellence, quality systems, regulatory compliance, and financial management + Proficiency with ERP systems… more
- PagerDuty (San Francisco, CA)
- …requires a strategic legal partner who can navigate complex technical and regulatory landscapes while driving business innovation. This role reports directly to the ... activities and future plans. + Has deep understanding of applicable laws and regulatory frameworks and can deftly apply legal requirements to help advise and draft… more
- BeOne Medicines (San Mateo, CA)
- …study/project teams supporting hematology studies and interact with Clinical, Regulatory , Statistical Programming, Data Management and other Research Scientists in ... meet analysis requirements, internal standard operating procedures, and external regulatory requirements. + Analyzes data and interprets results from clinical… more
- AbbVie (Irvine, CA)
- …Tissue Management Science, Product Development, Clinical, Medical Affairs, Quality, Regulatory , Health Economics Outcomes Research, Global Access & Pricing ... and economic claims. + Develops close working relationship with R&D, regulatory /legal, medical affairs, clinical, GMAP, HEOR, market research, operations, downstream… more
- Taiho Oncology (Pleasanton, CA)
- …Reports. + Investigator Brochures. + Population PK and/or Exposure-Response reports. + Regulatory Documents, including NDAs and MAAs and responses to questions from ... regulatory authorities. + Academic publications, including scientific meeting abstracts and peer-reviewed articles. + Lead the implementation of operational… more
- BeOne Medicines (Emeryville, CA)
- …Job:** + The individual should collaborate internally with Quality, Supply Chain, Regulatory Affairs and externally with CDMO to ensure timely and successfully ... project delivery at all stages. **Manage drug product technology transfer** + Coordinate with internal and external parties to establish tech transfer plan and project timeline + Lead the collaboration with all relevant functions to implement and complete… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …Analytics, Otsuka Information Technology (OIT), Sales Operations, and Medical/ Regulatory /Legal integrated business partners. **Minimum Qualification:** + Bachelor's ... degree in data sciences, computer science and 4-6 years of relevant experience **Preferred Knowledge, Skills, and Abilities:** + Demonstrated experience with scripting and implementing data analytics algorithms and models. Hands on experience using a modeling… more