- Capgemini (New York, NY)
- …and lessons learned. **Skills & Experience (Required)** + **12 years** in regulatory affairs ; direct leadership of **IND/NDA/BLA/MAA** submissions (10 successful ... (no sponsorship). **Preferred** + Former **FDA/CDER/CBER** reviewer experience. + VP/ Director Regulatory experience in **first-time submissions** (IND →… more
- City of New York (New York, NY)
- Job Description Reporting to the Senior Director of Intergovernmental Affairs , the Government Affairs Associate will provide support to the Office of ... Intergovernmental Affairs (IGA) and the leadership of NYCHA, specifically in...following: - Monitor, research and analyze proposed legislative and regulatory developments that impact NYCHA on the local, state… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- …with 12 years of relevant biopharmaceutical experience, at least 8 years of hands-on regulatory affairs or regulatory intelligence experience. + Balance of ... The Senior Director of Regulatory Intelligence will lead...+ Liaise with Legal and Public Policy and Government Affairs (PP&GA), as necessary, to ensure consistency in interpretation… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …development programs. + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory intelligence needs and ... The Associate Director of Regulatory Intelligence leads the...technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years'… more
- Veterans Affairs, Veterans Health Administration (Batavia, NY)
- …the outpatient Posttraumatic Stress Disorder Treatment Services at the Batavia VA Medical Center. The psychologist functions as part of an interdisciplinary team, ... privileging, educational and peer review activities, in accordance with Psychology and medical center policies. Participates as a non-voting member of the medical… more
- Veterans Affairs, Veterans Health Administration (Kings County, NY)
- Summary The VA New York Harbor Healthcare System (NYHHCS) is a multi-site medical system that includes a major medical facility in Manhattan, Brooklyn (including ... with accreditation requirements for VA, Joint Commission, CARF and other required regulatory guidelines. -Works closely with the Section Chief, Psychology and ACOS… more
- United Therapeutics (Albany, NY)
- …all field resources (slides, FAQ, talking points etc.) + Partner with Global Medical Affairs /product development, and global partners' subject matter experts to ... changes, and other external factors + Conduct learning needs assessments of medical affairs functions to determine training needs and priorities based… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …policies and external regulatory requirements. + Collaborate cross-functionally with Medical Affairs , Clinical Development, Regulatory , Legal, and ... The Senior Director , Medical Communications, CNS directs and...scientific accuracy, consistency, and alignment with the overall CNS Medical Affairs strategy. The role is a… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …to ensure scientific accuracy, consistency, and alignment with the overall Rare Disease Medical Affairs strategy. The role is a key leadership position within ... **Job Summary** The Director , Medical Communications directs Leads and...the Rare Disease Business Unit (BU) Medical Affairs team, engaging a small team… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …ensure scientific accuracy, consistency, and alignment with the overall Nephrology & Immunology Medical Affairs strategy. The role is a key leadership position ... **Job Summary** The Senior Director , Medical Communications, Nephrology & Immunology...within the Nephrology & Immunology Unit (BU) Medical Affairs team, influencing and engaging internal… more
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