- Merck & Co. (North Wales, PA)
- Job DescriptionReports to the Director / Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for ... and approval of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional… more
- Eisai, Inc (NJ)
- …difference. If this is your profile, we want to hear from you. The Medical Director , US Medical Affairs provides medical leadership for medical affairs ... key business processes. Responsible for approval of medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs and Commercial… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a living. Are you ready to make a difference? The Position We are seeking a Senior Director , Global Regulatory Portfolio Lead who will be responsible for ... as support/lead development and implementation of department policies. The Senior Director may also serve as a...and Princeton, NJ, as well as the broader Global Regulatory Affairs (GRA) organization Serves as an… more
- Merck & Co. (North Wales, PA)
- Job DescriptionUnder general supervision of an Executive Director / Senior Director , the Principal Scientist / Director is responsible for developing and ... divestment and product withdrawal.Support new technology development.Demonstrate an understanding of regulatory affairs and applies this understanding to the… more
- Merck & Co. (Rahway, NJ)
- …Executive Director , as a senior member of the Global Regulatory Affairs and Clinical Safety: Chemistry, Manufacturing and Controls Organization (GRACS ... Their role is pivotal in fostering alignment and global execution across Regulatory Affairs , R&D, Manufacturing, and our Commercial division, ensuring compliance… more
- Merck & Co. (Rahway, NJ)
- …execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Senior Clinical Director May Be Responsible For:Evaluating pre-clinical ... Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist)...closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage… more
- Eisai, Inc (Nutley, NJ)
- …Functions Medical Affairs Strategic Plans: Under the direction of the Senior Medical Director , work with key stakeholders, management, and functional area ... want to hear from you. Job Summary The Medical Director will provide medical leadership for medical affairs...for assigned therapeutic area. Under the direction of the Senior Medical Director , this role will be… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …creation of developmental and regulatory strategy in collaboration with Regulatory Affairs ; Drafts clinical development plans, protocol profiles and sections ... indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; Represents clinical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Area in certain instances, at the discretion of Executive Director of Medical Affairs . Assists the Senior Medical Director in developing agenda for and ... Plan (EGP), in collaboration with Senior Medical Director Serve as NNI Medical Affairs representative...Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning and supportive ... working with key stakeholders to develop and execute the medical affairs plan, including data generations (including RWE), post-marketing research, medical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with cross functional teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical Operations, ... Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small… more
- Merck & Co. (North Wales, PA)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.-Specifically, the Director may...development projects; andAssist the Senior Director , Executive Director , and/or… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …key stakeholder interactions include: Research and Early Development / Development / Global Regulatory Affairs / Global Safety / Local affiliates / Suppliers ... is an individual contributor role reporting to the Associate Director for GLP & GCP Audits in the Americas....audits considered to be complex or difficult (either as Senior Lead Auditor or in support of peers) Act… more
- Merck & Co. (Rahway, NJ)
- …there are important interactions with, inter alia, Quality Assurance, Finance, Regulatory , Clinical Supplies and legal in a highly matrix-based organization. There ... are some interfaces with Human Health/Global Medical Affairs (GMA).Primary activities:Provide Leadership to the country(ies): Build the best team and chart the… more
- Merck & Co. (Rahway, NJ)
- …placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be Responsible ForEvaluating pre-clinical and ... with talented and dedicated colleagues while developing and expanding your career.The Senior Director (Sr. Principal Scientist) has primary responsibility for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders.Summary The Director , Global eQMS Management QA GMP, reports to the Senior Director , Strategic GMP QA Operations. This individual is a member of ... and awareness across Global Quality and GMP related functions (Supply Chain, Regulatory Affairs , CMC, Pharmaceutical Technology) who are either direct or… more
- Merck & Co. (North Wales, PA)
- …medicines that help people around the globe. We are currently recruiting for Executive Director , US Commercial Leader for HIV.HIV is a franchise that consists of 3 ... challenges that impede progress toward ending the epidemic.The Executive Director , US Commercial Leader for the HIV Portfolio is...US Commercial Leader for the HIV Portfolio is a senior leadership position reporting directly to the Senior… more
- Insmed Incorporated (Bridgewater, NJ)
- …the reinforcement and ongoing growth of our culture. This position will report to the Senior Director , HCP and Payer Lead. This position does not have any direct ... of Record and media agencyWork closely with cross-functional partners including Legal, Regulatory , Compliance, and Medical Affairs , to align and compliantly… more
- Merck & Co. (North Wales, PA)
- …experienced, motivated, and passionate talent to serve as the Executive Director , US Commercial Leader, Atherosclerosis (USCL), for our investigational novel ... Collaborate with key stakeholders across the enterprise, including Medical Affairs , Manufacturing, Global Marketing, Global digital data and analytics, PDT/… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and study protocols.This position independently manages relationships with internal (CSPV, Regulatory , Clinical, Medical Affairs , HEOR and other stakeholders to ... centered around rare diseases and immune disorders. SUMMARYThe Associate Director , Pharmacoepidemiology position provides epidemiologic, methodological, and analytic support… more
