- Gilead Sciences, Inc. (Foster City, CA)
- …may not be clear/specific regulatory guidance. + Collaborates with colleagues across the global CMC RA organization, Gilead Regulatory Affairs , and affiliates on ... related topics. + Initiates or contributes to local and/or global process improvements which have a significant impact on...degree and 12+ years of experience in CMC Regulatory Affairs (CMC RA) or other relevant industry experience or… more
- Stryker (San Jose, CA)
- The **Senior Director , Regulatory Affairs ** is a key strategist, responsible for developing regulatory strategy for the **Endoscopy business unit** and ... leadership, Marketing, R&D, Clinical and Quality teams, the Senior Director and team will develop and advise on product...+ Leads advocacy activities of a more advanced and global strategic nature **Education / Work Experience:** + BS… more
- Takeda Pharmaceuticals (Boston, MA)
- … director will provide scientific & team leadership, guidance across global medical affairs activities for advanced stage molecules and/or pipeline ... will work in a multifunctional, matrix organization with other medical affairs functions ( global medical capabilities functions, oncology PMO, MSL teams),… more
- IQVIA (Durham, NC)
- …may require onsite visits to clients. **Role and responsibilities** + Represent Medical Affairs on the content review committee as the lead Medical Reviewer / ... 'second opinions' where appropriate. + Escalates issues to medical director where appropriate. + Be a leader and role...Promomats and/ or Aprimo desorable IQVIA is a leading global provider of clinical research services, commercial insights and… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …and help create possible, together. **Job Description** **POSITION OVERVIEW:** Regulatory Affairs (RA) Business Operations believe talented people deserve a great ... life cycle, including roles, systems, and processes. + Familiarity with global regulatory frameworks and submission processes (eg, NDAs, MAAs). + Proficiency… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …department and company goals and objectives. Essential Functions: + Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and clinical ... while balancing business benefits and risks. + Lead and Manage Global Regulatory Submission Activities: Oversee submission planning, authoring, reviewing, and… more
- Wolters Kluwer (Kennesaw, GA)
- …(within a corporate or agency environment) + Existing set of strong global media contacts across Tier 1 media, trade publications, and broadcast, preferably ... in North America + Proficient in quickly assessing situations and developing customer messaging and talking points for internal employees + Experience with crisis communications, including legal, investor and public relations implications. **Preferred… more
- Lilly (Indianapolis, IN)
- …are clearly positioned with the strategic priorities of the respective Medical Affairs business unit brand team(s), global Development team, Therapeutic Area ... medical strategies to support brand commercialization activities by working closely with the global Medical Affairs and brand teams, Global Patient… more
- NYU Rory Meyers College of Nursing (New York, NY)
- …and has served as Vice Provost for Academic Affairs , FAS Dean for Humanities, Director of Global Curriculum for CAS, Chair of the Department of Spanish and ... Position Summary Senior Vice President, University Relations and Public Affairs and Chief Communications and Marketing Officer New York University New York, NY New… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …stakeholders, typically carrying out the responsibilities with guidance from the Regulatory Affairs , Advertising and Promotion Director . The Manager Regulatory ... a regulatory advertising and promotion perspective with guidance from the Regulatory Affairs , Advertising & Promotion Director . + Creatively contribute to the… more