- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …relevant company SOPs, GPP (Good Publication Practices), ICMJE guidelines, and global regulatory /legal requirements, establishing governance frameworks to ensure ... with the Nephrology & Immunology BU Lead and cross-functional teams (eg, Global Integrated Evidence & Innovation, Clinical Development, Regulatory , Commercial)… more
- BeOne Medicines (Emeryville, CA)
- …**Cross-Functional & External Engagement** + Serve as the analytical liaison across GCO, Regulatory , Medical Affairs , Access, and Corporate Affairs to ensure ... **General Description:** Reporting to the Head/ Director of Clinical Trial Diversity, the Associate Director will operationalize BeOne's clinical trial diversity… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …standards. + ** Regulatory Guidance and Frameworks** : Closely work with Regulatory Affairs team to define and own the development of industry-specific ... organizational culture. **Qualifications:** + Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs , or related field (Master's or RAC… more
- Ascendis Pharma (Palo Alto, CA)
- …their skills. The Regulatory Project Manager will be an integral part of Global Regulatory Affairs , providing project management leadership to key ... across the Ascendis pipeline. As a part of the Global Regulatory Affairs team, you...team (specifically from: Talent Acquisition Partner or Human Resources Director ) is not allowed. If this occurs your ownership… more
- J&J Family of Companies (Irvine, CA)
- …development team members. + Partner with Clinical Research (and other partners, eg, Regulatory Affairs ) in the development and execution of product and/or ... Strategic Marketing (GSM), Health Economics and Market Access (HEMA), and Clinical Affairs (CA). Associate Medical Director , under limited supervision, in… more
- Pfizer (Sacramento, CA)
- …stakeholders via established triage process + In collaboration with US and/or Global Medical Affairs colleagues, partner with IM/SC Research & Development ... **ROLE SUMMARY** The Internal Medicine Field Medical, Director is responsible for providing Migraine therapeutic area/product expertise for the designated… more
- J&J Family of Companies (Irvine, CA)
- …development experience required + In-depth knowledge of ophthalmic clinical trial design, regulatory affairs , and Good Clinical Practice + Strong analytical, ... Entrepreneurship, Good Clinical Practice (GCP), Inclusive Leadership, Leadership, Ophthalmology, Regulatory Affairs Management, Relationship Building, Scientific Research,… more
- Genentech (South San Francisco, CA)
- …generation, ensuring alignment with Roche standards, legal frameworks, and evolving global regulatory expectations. External Partnerships & Community Impact + ... population health-related training. + Possess a sophisticated understanding of the evolving global and US regulatory , medical practice, and economic environments… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …study report (FSR), including authoring statistical sections. + Discusses strategies with Global Clinical Development and Regulatory Affairs regarding study ... team and key stakeholders across different functional areas such as clinical, regulatory affairs , asset management, safety and clinical operation. + Familiar… more
- Abbott (Alameda, CA)
- …This role ensures worldwide compliance with FDA, ISO 13485, EU MDR, and other global regulatory standards. The Director will provide strategic leadership, ... Group (MEG) and No Product Return (NPR) will lead global medical device vigilance, post-market surveillance, and regulatory...* Minimum 8-10 years of experience in Quality Systems, Regulatory Affairs , or Quality Assurance within the… more