- 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 30% overnight travel… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies required. Travel Ability ... centered around rare diseases and immune disorders. ResponsibilitiesEnsure global regulatory plans support a precision medicine approach eg integrated… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions ... healthcare providers, key stakeholders and policymakers. Our Market Access and Public Affairs professionals ensure that the latest therapies and products reach the… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the Global ... leadership while driving results.Collaborate with internal and external stakeholdersInteract with senior CSPV/ Medical Affairs leadership teams to ensure Quality… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with Novo Nordisk policies and procedures. Relationships This position reports to a Senior Director within the Clinical Data Science & Evidence (CDSE) - ... ready to make a difference? The Position The Associate Director , Research Partnerships (RP) is responsible for developing and...across CDSE and more broadly within Clinical, Medical and Regulatory , Market Access and Public Affairs . Externally,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both internal ... will help develop multiple products. In doing so, the Senior Medical Director will work across different...Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams to deliver and drive… more
- Merck & Co. (Rahway, NJ)
- …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)
- …cross-functional project teams, including Clinical Development, Clinical Operations, Biometrics, and Regulatory Affairs personnel to manage preparation of the ... written deliverables that support the clinical development and regulatory requirements of a clinical program. The Director...Writing team. Relationships The Director Medical Writing ( Director ) reports to a Senior Director… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …drive organizational action, guide the Business units and the Clinical, Medical, and Regulatory Affairs (CMR) teams on strategy development and execution. This ... Analytics functions and translating into business impact. Relationships Reports to the Senior Director , Enterprise Functions Insights Lead with direct management… more
- Tris Pharma (Monmouth Junction, NJ)
- …an experienced MD with expertise in the Pain therapeutic area to serve as Senior or Executive Medical Director . Title and salary commensurate with experience. ... The Executive/ Senior Medical Director provides leadership, direction and medical expertise for company’s clinical development programs specifically focused on… more
- Tris Pharma (Monmouth Junction, NJ)
- …in our Monmouth Junction, NJ facility for an experienced MD to serve as Senior Director or Director , Clinical Development. Title and salary commensurate ... of clinical study conduct; Collaborates closely with internal stakeholders, (ie Regulatory Affairs , Product Development, Research and Development (R&D), Quality… more
- Merck & Co. (Rahway, NJ)
- …placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be Responsible For:Evaluating 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)
- …and Research programs for development of early clinical studies. Provides senior level clinical representation at meetings with health authorities; Leads the ... creation of developmental and regulatory strategy; Accountable for performance of CROs; Routine interactions...strategy; Accountable for performance of CROs; Routine interactions with senior management of CRO, as needed; Accountable for clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.SummaryThe Associate Director (AD) is responsible for overseeing all activities related to Medical ... regulations, for their assigned TA. The AD partners with senior colleagues in developing and implementing improvements in medical...and is also an integral member of the Medical Affairs Team. This position plays a key role in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …responsible for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science (CS) ... collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management, Regulatory Affairs , and other RD functions to ensure effective delivery… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …clinical development and regulatory requirements of a clinical program. Relationships The Senior Medical Writer reports to a Director of Medical Writing. The ... personnel from Medical & Science, Clinical Pharmacology, Biostatistics, Clinical Operations, Regulatory Affairs , Global Safety, Data Management, and Non-clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …stage) within the Global Clinical Science function. This position may be at the executive director level or senior director level, depending on the scope and ... programs.- Partner and collaborate with Clinical Operations, Biostatistics and Data Management, Regulatory Affairs and other RD functions to ensure effective… more
