- Aequor (Newbury Park, CA)
- …Lead to manage GRT interactions The responsibilities of the Regulatory Affairs Senior Associate position are: Assist US Regulatory Lead to support regional ... primary authorship to routine regulatory correspondence (eg annual reports, investigator packages) Prepare regulatory packages and cross-reference letters to support… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a Senior Director (Sr. Principal Scientist) Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help ... our pipeline and drive our strategic priorities.Summary, Focus and PurposeThe Senior Principal Scientist - Regulatory Affairs Liaison is responsible for development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization ... and CSR safety narratives- May lead the development and updates of the Investigator 's Brochure (IB): author the clinical section and lead the development of the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization ... (TLF) and CSR safety narrativesMay lead the development and updates of the Investigator 's Brochure (IB): author the clinical section and lead the development of the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …understood by the target audience Collaborate with stakeholders to build sustainable investigator and site relationships and to ensure sites have resources and ... support to drive diverse recruitment Collaborate with stakeholders to identify, evaluate, and develop emerging research centers with diverse patient populations Together with site feedback and internal stakeholders, advocate for the needs of diverse patient… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …(HCPs), and other stakeholders. The Medical Director will also assist the Senior Medical Director in the development and execution of strategic priorities within ... at the discretion of Executive Director of Medical Affairs. Assists the Senior Medical Director in developing agenda for and executing national advisory boards,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …safety surveillance sub-function within the US East Coast Development Hub comprised of Senior Global Safety Leads, Global Safety Leads and Senior Global Safety ... to internal and external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development Hub. Key internal… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to internal and external stakeholders. Relationships This position will report to Senior Global Safety Lead/Director/ Senior Director - Safety Surveillance, US ... Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigator 's Brochure (IB), integrated safety summaries, abstracts and planned publications… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …limited to research partnerships and other collaboration agreements sponsorships, Investigator Sponsored Studies (ISS) and supplier service agreements Ensures ... programmatic initiatives Develop collaborative and positive relationships with constituents, senior leadership and external sponsors; engage with institutional partners… more
- Merck & Co. (Rahway, NJ)
- …regulatory agencies.Reports to Associate Vice President, Executive Director, or Senior Director in the General Medicine Therapeutic Area.Independently manages ... approval Worldwide Marketing Applications, Clinical Study Reports, protocols, Confidential Investigator Brochures before release from our company to external… more
