- 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
- 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
- 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
- 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
- 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
- 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)
- …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
- 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)
- 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
- Merck & Co. (North Wales, PA)
- …cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.-Specifically, the Director may be ... an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …including procedure generation, equipment qualification, assay validation updates, and regulatory filings Propose an integrated strategy including timelines ... Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one...treatment of multiple myeloma. Legend Biotech is seeking a Director , Analytical Lifecycle Management as part of the Technical… 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
- Merck & Co. (Rahway, NJ)
- …of Analytical Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality and ... cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated ... coding of AEs, medical history, and medications when needed Clinical Development Expertise Strategy : In collaboration with the Global Clinical Lead (GCL), if… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …drug development and life cycle management. Represents the function in global regulatory /heath authorities' meetings. High-level negotiation and oversight of ... submitted to health authorities globally. Represents the function at health authority meetings. Global BDO Strategy to Improve Drug Development: Sets the vision… 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
