- Houston Methodist (Houston, TX)
- …and the International Conference on Harmonization (ICH). This position communicates with regulatory affairs office for FDA submissions across multiple studies of ... procedures under the direct supervision of the Manager or Director (serves as a resource for regulatory ...N/A **LICENSES AND CERTIFICATIONS - PREFERRED** + RAC - Regulatory Affairs Certifications (RAPS) **OR** + CCRC… more
- J&J Family of Companies (Spring House, PA)
- …serving on multifunctional teams delivering clinical trials in an R&D or Medical Affairs setting. + Proficiency with regulatory submissions and interaction. + ... of Johnson & Johnson is recruiting for a **Senior Director , Head of Hematology R&D Data Science & Digital...Science-related projects for the CDTs. This will include both regulatory -grade and observational research. + Identify and procure data… more
- United Therapeutics (Research Triangle Park, NC)
- …across multiple functional groups (eg, Research and Development, Manufacturing, Validation, Regulatory Affairs , etc.). Negotiate and manage expectations across ... and mentoring or developing a member of your team. The Associate Director , QA Engineering will provide advanced support and subject matter technical expertise… 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
- Catalent Pharma Solutions (San Diego, CA)
- …with at least five (5) years' of experience in Quality Assurance or Regulatory Affairs with progressive responsibilities; + Experience in managing people, ... Director of Quality Catalent, Inc. is a leading...Safety, Quality performance, Operational Excellence, continuous improvement, error reduction, regulatory compliance, and sound fiscal responsibility. Lead the development… more
- Takeda Pharmaceuticals (Lexington, MA)
- …+ Serve as clinical liaison to Global Device Team, including engineering, regulatory affairs , quality, and commercial functions + Coordinate interdepartmental ... clinical development **Team Leadership & Development:** + Promote a culture of scientific excellence, adherence to regulatory and quality standards, and… more
- Danaher Corporation (New York, NY)
- …agents, and integrate results into products, studies, and evidence programs ( scientific , regulatory , market access, and post-market). You'll collaborate with ... innovation and unlock the full potential of the latest scientific advances. Together, we're expanding access to precision diagnostics...clinical, regulatory /quality, R&D, medical affairs , IT/security, and our… more
- Genentech (South San Francisco, CA)
- …partner functions (including Research, Product Development, Commercial, and Government Affairs ) and collaborating across the dynamic health ecosystem to ultimately ... more accessible and affordable for all. The Principal Medical Director / Medical Science Director is a...and identify knowledge gaps & opportunities for collaboration, & scientific exchange through various channels to drive medical progress… more
- Gilead Sciences, Inc. (Foster City, CA)
- …manages day-to-day operations, and ensures alignment with corporate objectives, regulatory requirements, and best-in-class standards. The Senior Director ... team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve… more
- Gilead Sciences, Inc. (Foster City, CA)
- …ensuring high-quality output and fiscal discipline. + Collaborate cross-functionally with Regulatory , Legal, Medical Affairs , CL&D, II&D, Global Marketing, and ... team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve… more