- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders.Summary This role is responsible for leading and mentoring a dynamic and global Regulatory Intelligence & Policy team, through direct and indirect line ... that DS is prepared to meet new or proposed global regulatory requirements and that DS has...should prioritize external engagement efforts for maximum impactDefines a global strategy for achieving policy-shaping objectives (eg… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …up to date- Support regulatory inspection related activities as required- Support Head, Global strategy and operations to develop and plan the Global QA ... Training and Documentation management team. This position will take direction from global strategy and operational QA leader, however is also accountable to the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects. ... into a global strategy .Responsible for ensuring aligned global regulatory strategy is endorsed by GPT and other governance bodies.Serve as… more
- Merck & Co. (Rahway, NJ)
- …providing commercial input on such activities as: target product profile development, global regulatory filing strategy , labeling, launch readiness reviews, ... for the oncology portfolio.- The Global Marketing Director will lead overall strategy development for...chain: basic science and biology, clinical development and innovation, regulatory processes, global launch dynamics, access and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the Global Regulatory Matrixed Team in defining and executing the global regulatory strategy for assigned programs to ensure timely and high-quality ... to make a difference?The Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …The purpose of this position is to oversee bioanalysis strategy from global development and global regulatory perspectives, set standards (industry best ... and future investments.Responsibilities- Oversees bioanalysis strategy from global development and global regulatory ... strategy from global development and global regulatory perspectives- Facilitates/oversees global … more
- Merck & Co. (Rahway, NJ)
- …interacts with worldwide regulatory agencies and/or subsidiaries with regard to global regulatory strategy /registration requirements for one or more our ... The Director , Regulatory Affairs Liaison is responsible for:Developing regulatory strategy for their assigned products, in order to optimize label… more
- 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 ... preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure that regulatory… more
- Merck & Co. (Rahway, NJ)
- …pharmaceutical, life sciences and/or healthcare space Understanding and experience with global regulatory requirements for Medical Device and/or AI algorithms ... diagnostics and pharma? Then you could be our new Global Marketing Director of Digital Diagnostics! -...be responsible for developing and leading the digital pathology strategy , market development, and global commercialization of… more
- Insmed Incorporated (Bridgewater, NJ)
- …expertise and guidance to internal stakeholders for successful development and implementation of global regulatory labeling strategy for Insmed marketed and ... project leads in the US, EU, and Japan, the Director , Regulatory Labeling will be responsible for...in the pharmaceutical industry, 7+ years of experience in global regulatory labeling Full understanding of the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …include: Clinical summary and overview documents in eCTD format for global regulatory submissions, including investigational medicinal product dossiers (IMPD), ... manage preparation of the written deliverables that support the clinical development and regulatory requirements of a clinical program. The Director will provide… more
- Insmed Incorporated (San Diego, CA)
- …, coordinated cross-functional project plans for products in accordance with the program strategy . In addition, the Associate Director of PM may be asked ... the development and timely completion of annual goals and input to the global product strategy Facilitates resource planning, financial, and capacity assessments… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …quality standards and timelines and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key ... 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Global Product Team in collaboration with Clinical Development, Regulatory , Project Management, Biostatistics, Pharmacology, and other departments to ... 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
- Insmed Incorporated (Bridgewater, NJ)
- …leads the development and implementation of global Medical Communications Strategy across regions. The Director will develop collaborative partnerships with ... interest and Insmed generated data. As the lead for global congress strategy in their assigned therapeutic area, the Director will lead cross-functional… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Nordisk, you will have the opportunity to build a life-changing career in a global business environment. We encourage our employees to make the most of their talent, ... closely with leaders in Finance, Commercial Insights & Analytics, and the Commercial Strategy and Marketing organization as well as other key functional areas within… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the FDA and other health authorities globallyCreates a forward-looking Diagnostic development strategy while keeping abreast of regulatory and policy updates in ... 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
- Merck & Co. (North Wales, PA)
- …medicines that help people around the globe. We are currently recruiting for Associate Director , US Marketing, HCP Strategy for HIV. Our company has been ... in the fight against HIV/AIDS by driving HCP marketing strategy across a franchise portfolio. The HCP Strategy...align on decisions, including field sales, marketing operations, Legal, Regulatory , Medical, etc. Our US marketing team has adopted… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... multiple complex and competing priorities simultaneously. Proven project management and strategy skills. Is experienced in leading complex initiatives of high dollar… more
