- Aequor (Newbury Park, CA)
- …for inclusion in regulatory submissions. Coordination and execution of regulatory affairs processes and deliverables. Works under under the direction ... zone based on business needs in the evenings. Ideal Candidate: Previous Regulatory Experience professionally is highly preferred. Knowledge of FDA. Degree in life… more
- 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
- 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
- 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
- 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
- Aequor (Thousand Oaks, CA)
- …supplemental drug applications/biologics license applications is strongly preferred Experience with regulatory documents in Regulatory Affairs , Research, ... Remote Copy of AMAGJP00012547 Scrubbed resume attached Regulatory Writing Senior Manager ln this vital role role you will serve as the functional area lead on… 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
- Eisai, Inc (Nutley, NJ)
- …hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning and supportive tactics mainly for GU therapeutic area. This ... working with key stakeholders to develop and execute the medical affairs plan, including data generations (including RWE), post-marketing research, medical… 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. (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 Senior Director… 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
- 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 Be Responsible… 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
- Lundbeck (Chicago, IL)
- …include continuous collaboration with all relevant support departments: marketing, medical affairs , regulatory , IT, sales operations, commercial analytics, etc., ... of growth!Open to candidates anywhere in the greater United StatesSUMMARY:The Senior Manager Sales Training and Development is primarily responsible for managing… 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
- 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
- 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
- Merck & Co. (North Wales, PA)
- … regulatory guidelines and compliance requirements pertaining to Medical Affairs operations, and, preferably, experience in navigating regulatory challenges ... Global Medical and Value Capabilities (GMVC) in Global Medical and Scientific Affairs (GMSA) that reports directly to the Director, Medical Operations, Innovation… more
