- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …activities and ways of working. This role will also work with the Global Regulatory Affairs Leadership Team (GRA-LT) to define DS' priorities, strategy and ... MD, JD preferred Experience Qualifications7 or More Years Experience in pharma Regulatory Affairs , with at least 3 years developing regulatory strategies… more
- Merck & Co. (Rahway, NJ)
- …(eg, CCDS, CCPPI, CCIFU) and US labeling for marketed products; and supporting country Regulatory Affairs in the development and maintenance of the EU Labeling ... and under the supervision of the Global Labeling Strategic Director , the GLL is responsible for:- Developing, maintaining, and... regulatory labeling point of contact on global Regulatory Affairs sub-teams to ensure delivery of… more
- Novo Nordisk Inc. (Chicago, IL)
- …occur at any time throughout the annual performance cycle. Relationships Reports to Sr . Director of CKD-Medical Affairs . Has direct supervisory ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...support representatives in answering physicians questions Works with Executive Director to define therapeutic area disease and treatment concepts… 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
- 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)
- Job DescriptionThe Senior Clinical Director ( Sr . Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Senior Clinical Director May Be Responsible For:Evaluating pre-clinical… 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
- 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 ... Medical Affairs and will assist the Executive Director and Sr . Director (where...Plan (EGP), in collaboration with Senior Medical Director Serve as NNI Medical Affairs representative… 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)
- …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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …access, commercial insights and analytics, sales, medical/CMR, legal, compliance, and regulatory . Other internal relationships include Public Affairs , Government ... Compliance, Finance, HEOR, and Market Research. The position has high exposure to senior management and requires a highly motivated individual who is able to work… more
- Merck & Co. (Rahway, NJ)
- …with talented and dedicated colleagues while developing and expanding your career.The Senior Director ( Sr . Principal Scientist) has primary responsibility ... placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be Responsible ForEvaluating pre-clinical and… 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
- 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
- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with external vendors and to contribute to study logistical conductance; with Regulatory Affairs to align study with health authority requirements; with ... design, and conductance of early development clinical studies; the preparation of regulatory documents to file IND and report studies; and the representation of… more
- Lundbeck (WA)
- …opportunity - Open to candidates anywhere in the greater United StatesSUMMARY:The Senior Manager, State Policy and Strategy position is responsible for serving as ... related to the state policy environment and collaborating with Government Affairs and cross-functional partners to ensure patient access to therapies, optimize… more
