- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …company's growth, thereby accomplishing corporate goals.Responsibilities:Develop and implement US regulatory strategy for assigned project(s). Strategize and ... with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development...will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support… more
- Catalent (Manassas, VA)
- Associate Director , Regulatory Affairs Position...of the Associate Director , Regulatory Affairs is to support regulatory strategy ... of regulatory submissions for clients. The Associate Director , Regulatory Affairs will be...in conjunction with clients in support of meetings with regulatory authorities Provide regulatory strategy … more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Director , Regulatory Affairs Liaison, is responsible for development and implementation of global regulatory strategy for their ... the Worldwide Regulatory Agencies and/or subsidiaries with regard to global regulatory strategy /registration requirements for one or more of our Company's… more
- Novo Nordisk Inc. (Chicago, IL)
- …TA priorities and business needs. Relationships This position may report into the Field Director , Medical Affairs (or in smaller TA's directly into the TA head). ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...scientific resources, communications, and training initiatives for the medical affairs team Serve on Clinical Trial Strategy … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …personnel. Relationships Report to the Director /Associate Director /Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop and maintain ... positive rapport and working relationships with other personnel in Regulatory Affairs , CMR, and other local and...complete documents for inclusion in these applications Review of regulatory strategy documents; eg, provides supervisor with… more
- Eisai, Inc (NJ)
- …Director , US Medical Affairs provides medical leadership for medical affairs strategy , planning and supportive tactics for assigned therapeutic area. This ... key business processes. Responsible for approval of medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs and Commercial… more
- Eisai, Inc (Nutley, NJ)
- …of digital strategy , effectiveness and innovation initiatives supporting US Medical Affairs and Research & Development. The person in this role will drive growth ... tools and platforms to further develop the digital competencies and strategy within Scientific Communications and Medical Affairs .Lead digital initiatives… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi ... into a global strategy .Responsible for ensuring aligned global regulatory strategy is endorsed by GPT and other governance bodies.Serve as a leader… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a Project Manager within the Strategy Realization Office (SRO) function of GMSA at our company, the successful applicant will play a critical role ... in leading major global initiatives aimed at enhancing Medical Affairs practices. The SRO is a recognized internal management consulting team within Medical… more
- Aequor (Newbury Park, CA)
- …Support the implementation of Veeva Vault, IDMP, EU CTR, and other regulatory initiatives. Work with stakeholders to gather requirements and develop solutions. ... Provide Subject Matter Expertise in Veeva Vault Configuration and Regulatory Processes to a global user base. Develop and deliver training materials and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. SummaryLeadership responsibility for global regulatory strategy to support the development of biomarkers, companion ... to develop regulatory expertise on IVDR. This person will develop regulatory strategy and provide input on IVDR requirements to enable and support timely… more
- Eisai, Inc (Nutley, NJ)
- …Summary The Medical Director will provide medical leadership for medical affairs strategy , planning and supportive tactics for assigned therapeutic area. ... Under the direction of the Senior Medical Director , this role will be responsible for working with...Responsible for approval of medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs… more
- Eisai, Inc (Nutley, NJ)
- …from you.The Sr Medical Director provides medical leadership for medical affairs strategy , planning and supportive tactics mainly for GU therapeutic area. ... 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)
- …activities and ways of working. This role will also work with the Global Regulatory Affairs Leadership Team (GRA-LT) to define DS' priorities, strategy ... leaders to define DS's unified position and external engagement strategy on key topics. This role will also define...preferred Experience Qualifications7 or More Years Experience in pharma Regulatory Affairs , with at least 3 years… more
- Merck & Co. (Rahway, NJ)
- …Work effectively with cross-functional partners including research and development, medical affairs , regulatory affairs , manufacturing, business development ... execution, target product profile development, health authority interactions, global regulatory filing strategy , organized customer interactions, and market… 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 ... cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.-Specifically, the Director may be… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …clinical trials is required Demonstrates technical expertise within Clinical Development, Medical Affairs , and Regulatory Affairs (CMR), staying up-to-date ... ensuring consistency and harmonization of the implementation of the CMR training strategy Ensuring CMR employees receive training on regulatory compliance,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Liasions to ensure successful implementation of CDx and data collection- Supports Regulatory affairs in providing content and providing review of documents ... FDA and other health authorities globally- Creates a forward-looking Diagnostic development strategy while keeping abreast of regulatory and policy updates in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and resource strategies for a VP Function of the Clinical Development, Medical & Regulatory Affairs (CMR) Business Unit. The ideal candidate will possess a ... of best practices. Relationships The Manager, reports to the Director , CMR Business Planning & Strategy . The...a VP Functional area of Clinical Development, Medical & Regulatory Affairs Works with business partners inside… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …leadership as needed; Participates in creation of developmental and regulatory strategy in collaboration with Regulatory Affairs ; Drafts clinical ... with external KEEs to refine study plans; Prepares and participate in regulatory agency meetings, if applicable; Defines study strategy across clinical… more
