- 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)
- …company's growth, thereby accomplishing corporate goals.ResponsibilitiesDevelop and implement US regulatory strategy for assigned project(s).Strategize and plan ... science and technology. With more than 100 years of scientific expertise and a presence in more than 20...with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development… more
- Eisai, Inc (Nutley, NJ)
- …Medical Director will provide medical leadership for medical affairs strategy , planning and supportive tactics for assigned therapeutic area. Under the direction ... Medical Affairs department for products in the therapeutic area. The Medical Director will utilize expert medical/ scientific knowledge in assigned therapeutic… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi ... science and technology. With more than 100 years of scientific expertise and a presence in more than 20...a global strategy .Responsible for ensuring aligned global regulatory strategy is endorsed by GPT and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … procedures. Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization ... coordination with clinical plans and marketing objectives. Experience with communicating the regulatory strategy , issues, and risks in written and verbal format… more
- Genmab (Yardley, PA)
- …of the time per our hybrid policy. This position will report to the Regulatory Strategy Team Lead. Responsibilities: The key responsibilities of this role will ... the US pharmaceutical market Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and… more
- Genmab (Woodbridge, NJ)
- …pharmaceutical commercial landscape Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and ... passionate leader to be a part of our Global Regulatory Affairs (GRA) organization. In this role, the ...Regulatory Affairs (GRA) organization. In this role, the regulatory leader will be primarily responsible for the development… 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 ... science and technology. With more than 100 years of scientific expertise and a presence in more than 20...with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development… more
- Genmab (Princeton, NJ)
- …antibody products in immuno-oncology and beyond. Reporting to the Global Medical Affairs Strategy Lead (MASL) the Director will be responsible for the ... with proven ability to translate and align commercial and scientific goals and objectives into actions. Director ...work as an integral part of the Medical Affairs Strategy Team in close alignment with Global Medical Affairs… more
- Merck & Co. (Rahway, NJ)
- …your past work with new assay or robotic technology evaluation and shaping scientific strategy both at the platform and program level.Project management and/or ... to bring analytical representation and expertise to project teams and support regulatory filings (eg, INDs/IMPDs and BLAs).-The Director selects, trains, and… more
- Merck & Co. (North Wales, PA)
- …placement, monitoring, analysis, regulatory reporting, and publication.-Specifically, the Director may be responsible for: Providing scientific and medical ... on scientific questions relevant to his/her areas of responsibility. The Director is responsible for maintaining a strong scientific fund of knowledge… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …as appropriate, in support of the development objectives for DCR-PHXC and assist Regulatory Strategy staff in the compilation of submissions and in the ... develop multiple products. In doing so, the Senior Medical Director will work across different functional teams to support...with SOPs, ICH, GCP and other national and international regulatory requirements Work with the VP Medical/ Scientific … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and ... areas centered around rare diseases and immune disorders. Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …manage preparation of the written deliverables that support the clinical development and regulatory requirements of a clinical program. The Director will provide ... level strategic input into development plans, study designs, and regulatory submissions. The Director will provide direction...Has a strategic portfolio mindset. Is able to influence strategy and translate strategy into daily operations… more
- Genmab (Princeton, NJ)
- …Managers, Scientific Writing, MW Writing,) to support product development strategy Ability to balance multiple tasks to meet priorities and timelines. ... Authoring Support Group will be part of the Global Regulatory Operations group and will develop and manage the...will develop and manage the authoring support group within Regulatory Affairs (RA) to ensure timely and high-quality document… more
- Eisai, Inc (NJ)
- …Medical Affairs department for products in the therapeutic area. The Medical Director utilizes expert medical/ scientific knowledge in assigned therapeutic area ... Director is responsible for approval of medical and scientific content of all relevant materials/communications. Essential Functions: Medical Affairs Strategic… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and ... areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to… 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 ... disease target. Using innovative thinking, state-of-the-art facilities and robust scientific methodology we collaborate to discover the next medical breakthrough.Our… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in the creation of the development strategy ensuring the highest scientific /medical standards in accordance with ethical and regulatory requirements across ... for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science (CS) Group Lead will… more
