- Novo Nordisk Inc. (Plainsboro, NJ)
- … regulatory expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute ... advise on development strategies, and deliver on associated regulatory activities Lead the Global Regulatory Matrixed Team in defining and executing the … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Policy activities focused on the USA, alongside coordinating the global team.Responsibilities Lead and manage a global regulatory intelligence and policy ... is responsible for leading and mentoring a dynamic and global Regulatory Intelligence & Policy team, through...of leading Regulatory Intelligence, this role will lead the development and implementation of a global… more
- Merck & Co. (North Wales, PA)
- …for projects of increasing complexity. Lead development and execution of detailed, global regulatory submissions of INDs, BLAs or post approval change ... Job DescriptionUnder general supervision of an Executive Director /Senior Director , the Principal Scientist /...lead the development and the implementation of internal regulatory strategies and provides mentoring and coaching to Sr.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects. Represents ... into a global strategy.Responsible for ensuring aligned global regulatory strategy is endorsed by GPT...or More Years of proven experience in a regional regulatory lead role7 or More Years of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Summary The Director , Head of Global Dossier Planning, Regulatory Operations is responsible for leading the dossier ... Director of Dossier Planning will ensure high quality regulatory submissions to health authorities including but not limited... of Dossier Planning will report to Head of Global Regulatory Operations and be an active… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational ... leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may...issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support...project teams for the diagnostic, in full alignment with Global Program Teams (GPT) for the therapeutic, covering all… more
- Merck & Co. (Rahway, NJ)
- …supporting the Disease Area Strategies for Melanoma.Reporting to the Global Disease Lead for Skin Cancers, The Director of Global Oncology Marketing ... engagement execution, target product profile development, health authority interactions, global regulatory filing strategy, organized customer interactions, and… more
- Merck & Co. (Rahway, NJ)
- …FI/CO modules.- This role reports to the Global Financial Business Management Director . Responsibilities: Leadership and Management: Lead a global team ... drive revenue and productivity, thereby advancing our company's contribution to global medical innovation.Enterprise IT (EIT) is an essential component of the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Director , Global Oncology Marketing (Brand) is responsible for maximizing the ... value of a specific indication(s) and/or tumor type(s) under the direction of the Global Brand Lead . Responsible for actively contributing to the development of… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Director , Global Oncology Communications The role of Director , Global Communications, Oncology is a unique ... for this role will work under the guidance of the Executive Director , Global Oncology Communications in a fast-paced and ever-changing… more
- Merck & Co. (Rahway, NJ)
- …, Global Marketing for Women's Cancer for the oncology portfolio.- The Global Marketing Director will lead overall strategy development for Women's ... commercial input on such activities as: target product profile development, global regulatory filing strategy, labeling, launch readiness reviews, organized… more
- Catalent (Harman, WV)
- Senior Director , Supply Chain Position Summary: The Senior Director , Supply Chain is responsible for leading the supply chain organization for Catalent Maryland. ... to the Vice President and General Manager, the Senior Director Supply Chain directs all facets of supply chain...and objectives related to Supply Chain activities.Work with the global and internal stakeholders to develop and optimize site… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. SummaryLeadership responsibility for global regulatory strategy to support the development of biomarkers, ... device company HA meetings as appropriateIn collaboration with therapeutic Regulatory leads and CDx lead develop key...RA Policy and Intelligence: Keep abreast of the changing global regulatory environment for devices and share/educate… more
- Merck & Co. (Rahway, NJ)
- … / co- lead activities as belowTarget product profile development, global regulatory filing strategy, launch readiness reviews, organized customer ... Job DescriptionWe are recruiting for a Director Global Oncology Marketing for a...communication planningThis role will also serve as the Asset Lead for MK-1308A and will have an opportunity to… more
- Merck & Co. (Rahway, NJ)
- …culture, talent development, technology introduction, and compliance.- However, one co- lead remains focused on non-sterile pipeline programs and infrastructure while ... one co- lead remains focused on sterile pipeline programs and infrastructure.-...compliance councils. Key performance indicators range from quality and regulatory compliance, operational excellence, pipeline program support, financial, talent… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical/oncology project development preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Aequor (Newbury Park, CA)
- …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 presentations to a global audience. Author/review/approve quality Regulatory Information Management...Six Sigma method to support team processes. As the Global Labeling Lead product lead … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... The Technology Management (mAb, Drug Substance, Drug Product, or New Modality) Lead is responsible for the management of technology transfer of the manufacturing… more
- Novo Nordisk Inc. (Chicago, IL)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
