- Takeda Pharmaceuticals (Boston, MA)
- …area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively ... area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively… more
- Gilead Sciences, Inc. (Atlanta, GA)
- … guidelines and requirements. **Preferred Qualifications:** + Prior inflammation clinical trials/operations experience in company sponsored clinical trials ... Partner closely with internal Clinical Operations, Clinical Development and Medical Affairs to ensure effective communication and unified messaging to investigator… more
- Takeda Pharmaceuticals (Boston, MA)
- …communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs , Quality Assurance, Medical Affairs , Marketing, ... strategy for and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees. + Ensure communication of all safety… more
- Gilead Sciences, Inc. (Foster City, CA)
- …inflammation , and serious respiratory and cardiovascular conditions. **KEY RESPONSIBILITIES** The Director , CMC Regulatory Affairs for Biologics is ... approval process in close partnership with other functions in PDM, Regulatory Affairs , and Clinical Development. + Responsible for development of regulatory… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Gilead and help create possible, together. **Job Description** We are seeking a Director within Phase 4 Research in Liver, Inflammation , Respiratory Viruses, and ... Established Products (LIVE) to join our Global Medical Affairs team. This role is responsible for leading the...+ Must be fully cognizant of and adhere to regulatory and legal (Business Conduct) requirements for clinical trials… more
- Amgen (Washington, DC)
- …investigators, and functions conducting the studies. + Collaborate with Medical Affairs , Clinical Development, Clinical Operations, Regulatory , Safety, Strategic ... inflammation . + Deep understanding of clinical trial operations, regulatory requirements, and digital health technologies. + Proven experience implementing… more
- Pfizer (New York, NY)
- The Director , HEOR Statistics will provide statistical leadership and technical support for Pfizer projects involving health economics and outcomes research (HEOR). ... Outcomes Assessment Group), Statistics, Clinical Pharmacology, Clinical Development, Medical Affairs , Epidemiology, Programming, and other groups contributing to HEOR… more
- Amgen (Washington, DC)
- …world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation , General Medicine, and Rare Disease- we reach millions of patients each ... transform the lives of patients while transforming your career. Clinical Research Medical Director , Uplizna **What you will do** Let's do this. Let's change the… more
- Amgen (Washington, DC)
- …world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation , General Medicine, and Rare Disease- we reach millions of patients each ... the lives of patients while transforming your career. **Clinical Research Medical Sr. Director - Thoracic Oncology** **What you will do** Let's do this. Let's change… more
- Gilead Sciences, Inc. (Foster City, CA)
- …: Ability to develop deep and credible collaborations with partners in Medical Affairs , Research, Development, Value & Access, and Regulatory groups, as well ... that will improve the lives of patients with life-threatening illnesses worldwide. **Senior Director - Pipeline - HIV & Emerging Viruses** At Gilead, we are driven… more
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