- 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
- 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
- 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
- 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
- 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. (North Wales, PA)
- …promotional review divisions of FDA (OPDP/APLB) or experience developing/leading the regulatory strategy for a product filing/launchUnderstanding of the product ... Job DescriptionReports to the Director /Senior Director in the Office of...strategy discussions and extended team meetings and providing regulatory guidance and perspective on marketing strategies and promotion… 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)
- …The Executive Director , as a senior member of the Global Regulatory Affairs and Clinical Safety: Chemistry, Manufacturing and Controls Organization (GRACS ... of CMC professionals and ensuring high rigor in CMC regulatory strategy as well as delivery of...is pivotal in fostering alignment and global execution across Regulatory Affairs , R&D, Manufacturing, and our Commercial… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required. Position is ... Area in certain instances, at the discretion of Executive Director of Medical Affairs . Assists the Senior...and Global HQ. Key internal relationships include Field Medical Affairs , Medical Strategy & Operations, Medical Information,… more
- Merck & Co. (North Wales, PA)
- …mitigation measures.Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of increasing complexity.Lead ... 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)
- …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
- 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
- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs , etc. Qualifications: Successful candidates will be ... tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this work. Possesses in-depth… 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
- Insmed Incorporated (Bridgewater, NJ)
- …of Record and media agencyWork closely with cross-functional partners including Legal, Regulatory , Compliance, and Medical Affairs , to align and compliantly ... Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , HCP Marketing will be a key member of the Brand team for… more
