- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …As a result, this role will need to partner closely with teams and senior leaders from across Regulatory Affairs , as well as cross-functional ... Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, reporting, and… 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Vice President, Regulatory Affairs , General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and ... an effective implementation and oversight model to maintain best-in-industry regulatory compliance.The Vice President Regulatory Affairs ,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 30% overnight travel required; Qualifications MD ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...instances, at the discretion of Executive Director of Medical Affairs . Assists the Senior Medical Director in… 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 (Nutley, NJ)
- …key business processes. Responsible for approval of medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs and Commercial ... your profile, we want to hear from you.The Medical Director, US Medical Affairs provides medical leadership for medical affairs strategy, planning and supportive… more
- Merck & Co. (North Wales, PA)
- …requirements. In the clinical arena, RDH works with key functional groups within Global Regulatory Affairs , GCTO and others to implement the regulatory ... Work Experience Experience/Skills We are Looking for: Minimum:-Bachelor's Degree in Regulatory Affairs , Quality Assurance, Clinical Affairs ,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …leadership while driving results.Collaborate with internal and external stakeholdersInteract with senior CSPV/ Medical Affairs leadership teams to ensure Quality ... centered around rare diseases and immune disorders. Summary The Senior Director, Head Global PV Quality (DSI/DSE) reports to...key business function and collaborate with RD and Medical Affairs Quality to provide clinical safety QA advise wherever… more
- Merck & Co. (Rahway, NJ)
- …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 Senior Director May… 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 ... Development, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams to deliver and drive the timely… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …personnel from Medical & Science, Clinical Pharmacology, Biostatistics, Clinical Operations, Regulatory Affairs , Global Safety, Data Management, and Non-clinical ... development and regulatory requirements of a clinical program. Relationships The Senior Medical Writer reports to a Director of Medical Writing. The Senior… more
- Merck & Co. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. Specifically, The Senior Clinical… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the Product Material Review Team (PMRT) with the Legal, and Medical Affairs departments, ensuring consistency of materials across brands and departments, adherence ... cross functional assistance for PGC, Learning Management System (LMS) and Regulatory , as needed. ResponsibilitiesEditorial Review of Materials Review and consult… 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 leads ... for assigned therapeutic area. Under the direction of the Senior Medical Director, this role will be responsible for...Responsible for approval of medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …number of stakeholders across CDSE and more broadly within Clinical, Medical and Regulatory , Market Access and Public Affairs . Externally, this individual is ... cross-functional teams, including members of the CDSE team, clinical development, medical affairs , regulatory , and commercial, to facilitate the integration of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …partners, including but not limited to: Global Clinical Operations, Global Regulatory Affairs , Biostatistics and Data Management, Epidemiology, Patient Advocacy, ... to make recommendations for process improvements - Compliance- Partner with Global Regulatory Affairs to ensure current regulatory requirements are… 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 ... on local and global project teams. This role will be a senior member of the Regulatory , Quality and Clinical Reporting (RQC) team, and will provide mentorship… more
- Tris Pharma (Monmouth Junction, NJ)
- …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...etc.); Designs and implements clinical trials ensuring compliance with regulatory standards and industry best practicesOrchestrates and manages clinical… 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
