- 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. (Rahway, NJ)
- …and solutions to the world.Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:Developing regulatory ... Job DescriptionOur Regulatory Affairs team bring new medical...regulatory agencies and/or subsidiaries with regard to global regulatory strategy /registration requirements for one or more… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …level, while also seeking their input and feedback to inform state government affairs strategy and engagement. Contributes to internal and external advocacy and ... diseases and immune disorders.Summary With the Head of Government Affairs & Public Policy, this position will help lead...Policy, develop, lead and prioritize Daiichi Sankyo's legislative and regulatory engagement and strategy in the states… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …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
- 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
- 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
- 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
- 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
- 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)
- …collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management, Regulatory Affairs , and other RD functions to ensure effective delivery ... for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical Science (CS) Group Lead will… more
- Merck & Co. (Rahway, NJ)
- …effectively with cross-functional partners including research and development, medical affairs , regulatory affairs , manufacturing, Health Economics ... Job DescriptionWe have an exciting Director opportunity to join our global oncology marketing...including product development team, target product profile development, global regulatory filing strategy , launch readiness reviews, organized… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionCompanion Animal Global Marketing - Director , Parasiticide Portfolio MarketingThe Companion Animal (CA) Business unit leads strategy development ... categories in the Companion Animal Health market.In this new position, the Director , Parasiticide portfolio Marketing will lead the brand and product portfolio… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs , etcQualifications: Successful candidates will be able ... tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this workPossesses in-depth… 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
