- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …company's growth, thereby accomplishing corporate goals.ResponsibilitiesDevelop and implement US regulatory strategy for assigned project(s).Strategize and plan ... preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure that regulatory… 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
- Genmab (Yardley, PA)
- …is looking for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization. In this role, you will be primarily ... our hybrid policy. This position will report to the Regulatory Strategy Team Lead. Responsibilities: The key...include, but are not limited to: Act as the US/ Global Regulatory Leader (GRL) for assigned project(s)… more
- Genmab (Woodbridge, NJ)
- …is looking for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization. In this role, the regulatory leader ... of US regulatory strategies and have the role of Global Regulatory Strategist to advance Genmab's portfolio of development and marketed drugs. This… more
- Genmab (Princeton, NJ)
- …products in immuno-oncology and beyond. Reporting to the Global Medical Affairs Strategy Lead (MASL) the Director will be responsible for the development and ... as part of the asset life cycle management. The Director should have a strong background and experience in...work as an integral part of the Medical Affairs Strategy Team in close alignment with Global … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … regulatory procedures. Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device Development and ... other research areas centered around rare diseases and immune disorders. ResponsibilitiesEnsure global regulatory plans support a precision medicine approach eg… 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
- 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. (North Wales, PA)
- Job DescriptionThe Scientific Strategy lead plays a critical role in the launch of our adult pneumococcal vaccine, a critical growth driver for the organization and ... high priority, amidst a highly competitive and dynamic market. The Scientific Strategy Lead w ill be responsible for developing the strategies and relevant… more
- Genmab (Princeton, NJ)
- …The Role The Team Lead for Authoring Support Group will be part of the Global Regulatory Operations group and will develop and manage the authoring support group ... within Regulatory Affairs (RA) to ensure timely and high-quality document...implementation of submission templates, establish governance board responsible for global authoring templates and global dossier submission… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …oncology franchise products, in alignment with key global and regional functions. The Global Director of HEOR & RWE Oncology will lead the HEOR and RWE ... strategy and tactical plans, including the implementation of global health economic models, global value dossiers,...an effective use of HEOR and RWE methods. The Director will provide HEOR and RWE strategic direction to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a satisfactory regulatory compliance level for these organizations for local and global markets. Liaises with regulatory agencies as needed and internally on ... with Global External Supplier QA teams.Collaborate with Global Quality Management System (QMS) teams on regulatory...diplomacy.Ensure effective influential skills to support the vision and strategy of the Global QA mission across… 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
- 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …may serve as chair of Core Medical Team, at the discretion of the Executive Director Represent NNI Medical Affairs on Global Core Medical Team (CMT) Collaborate ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...ready to make a difference? The Position The Medical Director serves as the subject matter expert for our… more
- Genmab (Princeton, NJ)
- …to be our best, and authentic is essential to fulfilling our purpose. Senior Director , Global Program Leader Genmab is seeking an experienced Global ... This is a leadership position within Genmab, accountable for driving the strategy and execution of 1-2 clinical stage development programs. This position will… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Director Safety & Environment The Rahway Environmental, Health, and Safety (EHS) Director is responsible for development and ... laboratories, clinical manufacturing, facility management and office areas for global teams as part of the Corporate Headquarters.- The...as part of the Corporate Headquarters.- The Rahway EHS Director is a member of the Rahway Site Coordination… 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
