- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a multidisciplinary Global Regulatory Team (GRT) to develop global regulatory strategy and plans for assigned global ... program regulatory risks, and opportunities in the development of global regulatory strategy and plans, considering therapeutic area strategy ,… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPrincipal Scientist / Director , GLOBAL REGULATORY CMC Biologics (R5)Under general supervision of an Executive Director /Senior Director ... mitigation measures.Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of increasing complexity.Lead… more
- Daiichi Sankyo, Inc. (Bernards, 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. (Bernards, 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
- Merck & Co. (North Wales, PA)
- …corporate standards and policies and business objectives.Actively participate in labeling and global regulatory team meetings to ensure support for anticipated ... Job DescriptionReports to the Director /Senior Director in the Office of...review divisions of FDA (OPDP/APLB) or experience developing/leading the regulatory strategy for a product filing/launchUnderstanding of… more
- Daiichi Sankyo, Inc. (Bernards, 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
- 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 ... across multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential Functions Serve as a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …oncology, a Job Summary: The position will define and oversee the translational strategy /plan for oncology therapeutic program/s in global R&D. The successful ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Merck & Co. (Washington, DC)
- Job DescriptionPosition Description: Associate Director , Policy Strategy and Capabilities The Associate Director , Policy Strategy and Capabilities is ... Planning & External Engagement team, reporting to the Executive Director , Policy Development & Strategy .The Associate ...Director in conducting analyses to produce reports on global policy environment as requested by Executive Director… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global RD and PV QA organizational strategy in collaboration with the Associate Director Global Strategy and Operations and Head Global ... Strategy and Operations. In collaboration with the Associate Director Global Strategy and Operations and Head Global Strategy and Operations,… more
- Daiichi Sankyo, Inc. (Bernards, 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)
- 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)
- …CMR, Global , Field Sales, Account Management, Analytics, Investor Relations, Regulatory , and all others, including global colleagues/counterparts, on a ... CMR, HEOR, Global , Field Sales, Account Management, Analytics, Investor Relations, Regulatory , and all others on a routine basis Liaises with HQ counterparts on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …advancement of the global portfolio.Responsible for regional execution of the global strategy and performance of the function and regional team members.Leads ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director , Global Process Validation as part of the Technical Operations team ... establish cell therapy standards, policies, procedures across the validation lifecycleAlign global process validation strategy , comparability plans and data… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to asset teams to enable seamless tumor-specific clinical development and strategy .Responsibilities- Accountable for developing the Global Clinical Science ... multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science...and access and commercial business units to ensure unified Global Clinical Science Strategy . In conjunction with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the ... and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV)… more
- Merck & Co. (Rahway, NJ)
- …the oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy , lead activities, and develop a ... Job DescriptionOur company is a global health care leader with a diversified portfolio...and influence bridging strategies across the portfolio. The Biopharmaceutics Director will work with their direct reports to proactively… more
- Daiichi Sankyo, Inc. (Bernards, 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 ... contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC...team and serves as ad hoc member to the Global Project Team for late stage projects. This position… more
