- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …statistical expertise/input in the drug development including clinical development plan and regulatory submission strategy. This is a strategic and critical role in ... TFLs for interim or final analyses + Participate strategic planning of regulatory interactions and Provides tables and listings for FDA meeting briefing packages.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …an active therapeutic area with phase 3 and 4 PBC studies and global regulatory filings underway or expected, with potential for work across earlier phases, as well. ... study planning, conduct, and read-out; lifecycle planning; scientific communication; regulatory filings; real world evidence strategies to support clinical programs;… more
- AbbVie (South San Francisco, CA)
- …and collaborative role, the Director works in partnership with clinical and regulatory experts to advance medicines to our patients. Responsibilities: + Lead the ... or those of a team. Lead statistical strategy for project development and regulatory submission. + Direct and review the development of design, analysis and… more
- MetroLink (Los Angeles, CA)
- …and utilities to ensure compliance with railroad engineering standards and regulatory requirements. This position involves managing projects and tasks as part ... substitute for a portion of required experience. PREFERRED QUALIFICATIONS + Professional Engineer's license + Prior experience working on railroad structures… more
- SpaceX (Sunnyvale, CA)
- …mobile dead zones around the world. In this role, you will drive SpaceX's regulatory and policy strategy to enable this ground-breaking service with a focus on ... policy with a world class team. RESPONSIBILITIES: + Lead regulatory strategy and policy development end to end, towards...+ High aptitude to jump into new domains + Professional fluency in French, Spanish, Portuguese, Japanese or other… more
- Bristol Myers Squibb (San Diego, CA)
- …This hybrid role combines the scientific writing of key clinical and regulatory documents with oversight of medical writing vendors, timelines, resources, and ... Writing (70%)** + Author, edit, QC, and publish high-quality clinical and regulatory documents in accordance with ICH, GCP, and company standards including: +… more
- AbbVie (Irvine, CA)
- …and combination products. The role serves as Deputy Person Responsible for Regulatory Compliance for assigned Device Legal Manufacturer under EU MDR 2017/745, ... office Minimum). Responsibilities: + Serves as the Deputy Person Responsible for Regulatory Compliance for assigned Device Legal Manufacturer under EU MDR 2017/745,… more
- GE Aerospace (San Ramon, CA)
- …function to help arrive at a decision. **Required Qualifications** + Statutory and insurance regulatory requirements a must. + Prior technical controllership and ... facts and formulate technical accounting positions, considering statutory & regulatory guidance, insurance industry practices. **Desired Characteristics** +… more
- AbbVie (Irvine, CA)
- …(Development, Discovery, Development Sciences, Operations, Commercial, Market Access, Regulatory , Safety, Project Management, Medical Affairs, etc., and substantial ... Brand Team, CMC, Integrated evidence strategy team, Value and Access team, Regulatory strategy, etc.). + Ensure development and alignment with deliverable team… more
- Albireo Energy, LLC (Anaheim, CA)
- …and associate PMs, mentoring them on best practices and supporting their professional development. Resource and Subcontractor Management: + Lead the coordination and ... and Standards: + Ensure full adherence to company standards and regulatory requirements (federal, state, and local), proactively addressing potential compliance… more