- Genentech (South San Francisco, CA)
- …Team, alongside other senior leaders such as the VP, Head of Scientific Operations. This individual will manage a team of two Medical Science Health Population ... environments impacting Roche/Genentech, coupled with thorough knowledge of US regulatory /FDA requirements. + Scientific credibility and enterprise thinking… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …with cross-functional teams such as Marketing, Operations, Finance, Regulatory Affairs , Quality Assurance, Medical & Scientific Affairs , Legal, ... or franchises through strong collaboration with sales, marketing, operations, finance, regulatory affairs , quality assurance, medical/ scientific affairs… more
- Merck (South San Francisco, CA)
- …+ Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. **Specifically, The Clinical Director May Be… more
- Genentech (South San Francisco, CA)
- …stakeholders, including Commercial, Public Affairs & Access, US Medical Affairs , Legal and Regulatory , and cross-functional global counterparts and other ... **The Position** ** Senior Manager, Product Public Relations** **Why Genentech** From...public relations strategies that are integrated with Commercial, Public Affairs & Access, US Medical Affairs , cross-functional… more
- Bristol Myers Squibb (Brisbane, CA)
- …(Masters, PhD, PharmD, BSN, etc.) with at least 3+ years of Regulatory Affairs experience in the pharmaceutical industry. **Key Competency Requirements** ... the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies. + Ability to broadly… more
- Bayer (Berkeley, CA)
- …training and Locally drives the deficiency letter remediation process working with global Regulatory Affairs , supporting global RA requests and change control at ... internal audits, data integrity (DI), combination product, site compliance issues, regulatory inspection findings, Quality Management Review items, etc.) using … more
- Pfizer (South San Francisco, CA)
- …and external partners, such as project leaders, research units, biostatistics, regulatory affairs , clinical pharmacology, human genetics, translational oncology, ... strategy and plan for the assigned molecule(s)/indication(s) + Responsible for scientific leadership and execution of clinical studies and delivering on innovative… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …statistical sections. + Discusses strategies with Global Clinical Development and Regulatory Affairs regarding study design and complex analysis issues, ... team and key stakeholders across different functional areas such as clinical, regulatory affairs , asset management, safety and clinical operation. + Familiar… more
- Gilead Sciences, Inc. (Foster City, CA)
- …direction + Ensures compliance with all applicable laws, regulations and regulatory guidelines governing commercial and scientific interactions withhealthcare ... critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as...islatravir. In this role, you'll report directly to the Senior Director, HIV Treatment Marketing ISL-LEN and play a… more
- AbbVie (Irvine, CA)
- …brands (Development, Discovery, Development Sciences, Operations, Commercial, Market Access, Regulatory , Safety, Project Management, Medical Affairs , etc., and ... leader who is the project's primary point of contact for Pipeline Governance and senior management. + Has a broad vision for the asset and leads the effort… more