- University of Rochester (Rochester, NY)
- …office workflows, accounts receivable collaboration, payer rules, compliance, and regulatory requirements. The Assistant Coding Manager must exhibit exceptional ... Additionally, this role is responsible for ensuring compliance with all regulatory requirements and maintaining adherence to coding standards to ensure that… more
- Veterans Affairs, Veterans Health Administration (Philadelphia, PA)
- …precision mental health care. 2. Provides consultation to investigators on all regulatory oversite of the research portfolio and in particular clinical trials. ... and family psychotherapy. 5. Provides consultation to professional staff within CMC VAMC system and to community providers, concerning clinical assessment findings… more
- Sanofi Group (Washington, DC)
- …support in R&D for pre-clinical work, bioassay and biomarker research and/or CMC , biological assay, and biomarker research. He/She will work in close collaboration ... accurate assessments are made for decision-making, while ensuring compliance with regulatory expectations. **Main responsibilites** Acts as the lead statistician and… more
- BeOne Medicines (Emeryville, CA)
- …worldwide, Commercial Supply Chain, CMO Project Managers, Alliance Managers, Quality and CMC Development partners to ensure supply continuity with optimal cost and ... requested. * Partner with key global stakeholders from Supply Chain, Packaging, CMC manufacturing and Quality on CMO supplier selection, negotiation and management.… more
- AbbVie (North Chicago, IL)
- …This position will be an integral part of the product development and CMC teams and will have strong collaborations with several stakeholders, including discovery ... the cross-functional Product Presentation and Device Strategy Team (PPDST) and the CMC team. + Effectively and timely communicates study plans, risks and mitigation… more
- AbbVie (South San Francisco, CA)
- …. Job Description Sr. Scientist I Cell/Molecular Biology The Development Sciences Biologics CMC Drug Substance Cell Line Development Group in South San Francisco, CA ... lab notebook. + Author detailed technical reports that support regulatory filings at all stages from IND to BLA....biology screens + Familiarity with Chemistry, Manufacturing and Controls ( CMC ) and specifically CHO cell line development for GMP… more
- Gilead Sciences, Inc. (Foster City, CA)
- …quality attributes, propose and justify analytical control strategies, author relevant regulatory filings for biologic drug substance and drug product. + Lead ... with LC-MS based biologics characterization and data analysis to support CMC process development + Experience with analytical method development, validation, and… more
- Integra LifeSciences (Plainsboro, NJ)
- …will provide quality compliance support to the Collagen Manufacturing Center ( CMC ) Plant. This function shall participate in the development, review and/or ... Device Directives, Canadian Medical Device Regulations, and other applicable regulatory agencies. Experience with assessing quality suppliers and purchasing… more
- Capgemini (New York, NY)
- …**Your Role** As a Senior Consultant, you'll act as a **trusted regulatory advisor** for pharma and biotech clients, leading engagements on **submission readiness ... (IND/NDA/BLA/MAA)** , ** regulatory strategy** , **eCTD compilation/automation** , **CDISC compliance** , and **inspection preparedness** . You'll pair deep … more
- Amgen (Cambridge, MA)
- …leader in delivering superior, robust drug product manufacturing processes, high-quality CMC sections, and ensuring supply of commercial products. Drug Product Team ... integrated development of combination products, process improvements, life cycle changes, regulatory submissions, annual product reviews, etc. DPTLs are part of an… more