• ProKatchers (Gaithersburg, MD)
    Job Description: As a Regulatory Affairs professional within client, you will play a key role in channeling our scientific capabilities to make a positive ... impact on changing patients' lives. In Regulatory Affairs , our teams influence the development of our innovative pipeline, define the regulatory strategy for… more
    JobGet (03/07/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …or More Years in the pharmaceutical industry preferred1 or More Years in regulatory affairs requiredExperience in (s)NDA/BLA filing to FDA preferred Travel ... 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
    HireLifeScience (03/19/24)
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  • Eisai, Inc (Nutley, NJ)
    …platforms to further develop the digital competencies and strategy within Scientific Communications and Medical Affairs .Lead digital initiatives ensuring ... can be used to develop solutions and drive best practices within Scientific Communications and Medical Affairs .Drive oversight, project management and delivery… more
    HireLifeScience (02/07/24)
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  • Merck & Co. (North Wales, PA)
    …five years of pharmaceutical/biologics industry or related experience with an emphasis in regulatory or scientific disciplines, including a minimum of two years ... Job DescriptionReports to the Director /Senior Director in the Office of...all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to… more
    HireLifeScience (03/01/24)
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  • 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 ... and immune disorders. Summary Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's … more
    HireLifeScience (03/01/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …or More Years relevant pharmaceutical experience including experience within Regulatory AffairsUnderstanding of scientific content and complexities and ... 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… more
    HireLifeScience (03/01/24)
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  • 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 ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
    HireLifeScience (03/03/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... science and technology. With more than 100 years of scientific expertise and a presence in more than 20...serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational… more
    HireLifeScience (02/23/24)
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  • Eisai, Inc (NJ)
    …business processes. Responsible for approval of medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs and ... profile, we want to hear from you. The Medical Director , US Medical Affairs provides medical leadership...department for products in the therapeutic area. The Medical Director utilizes expert medical/ scientific knowledge in assigned… more
    HireLifeScience (02/14/24)
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  • Novo Nordisk Inc. (Chicago, IL)
    …lives for a living. Are you ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to ensure credibility and ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...needs. Relationships This position may report into the Field Director , Medical Affairs (or in smaller TA's… more
    HireLifeScience (03/20/24)
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  • Eisai, Inc (Nutley, NJ)
    …business processes. Responsible for approval of medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs and ... this is your profile, we want to hear from you. Job Summary The Associate Director , Global Medical Affairs will provide medical leadership for medical affairs more
    HireLifeScience (01/25/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …More Years Pharmaceutical industry and Regulatory operations required.4 or More Years regulatory affairs including filing NDA and sNDA. BLA filing to FDA ... science and technology. With more than 100 years of scientific expertise and a presence in more than 20...areas centered around rare diseases and immune disorders.Summary The Director , Head of Global Dossier Planning, Regulatory more
    HireLifeScience (03/25/24)
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  • Merck & Co. (Rahway, NJ)
    …(RPP) organization, which operates within the larger framework of Global Regulatory Affairs , Clinical Safety, and Pharmacovigilance (GRACS), Operations, Process, ... Job DescriptionThe Regulatory Project Manager (RPM) is a key member...a related role requiredBachelor's degree required; concentration in a scientific or applied discipline preferredProject management certification (PMP) and/or… more
    HireLifeScience (03/23/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …relationships include working with Headquarters, NA CMR including Clinical Trial Management, Medical Affairs , Regulatory Affairs and other NNI skill areas. ... trial reports, statistical reports, investigator's brochures, INDs, NDA and responses to Regulatory questions Provide medical and scientific input to advisory… more
    HireLifeScience (03/15/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …Vice President, Clinical Data Science & Evidence (CDSE) in Clinical, Medical and Regulatory Affairs (CMR) and has broad responsibility for managing multiple ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...ready to make a difference? The Position The Executive Director , Real World Evidence (RWE), is responsible for assuring… more
    HireLifeScience (03/18/24)
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  • Merck & Co. (Rahway, NJ)
    …- Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... entire cycle of clinical development,-including-study design, placement, monitoring, analysis, regulatory reporting, and publication.-- - Specifically, the Director more
    HireLifeScience (03/05/24)
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  • Merck & Co. (Rahway, NJ)
    …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Senior Director May Be… more
    HireLifeScience (03/09/24)
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  • Eisai, Inc (Nutley, NJ)
    …If this is your profile, we want to hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning and supportive ... and oversight of Phase IV clinical trial programs within the Medical Affairs department. She/He utilizes expert medical/ scientific knowledge in assigned… more
    HireLifeScience (01/19/24)
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  • Merck & Co. (North Wales, PA)
    …working effectively with cross-functional partners including research and development, medical affairs , regulatory affairs , Business Development & Licensing, ... Job DescriptionWe are currently recruiting for an Executive Director , Oncology Portfolio Strategy, Global Market Access -Our Oncology access team is dedicated to… more
    HireLifeScience (03/16/24)
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  • Merck & Co. (Rahway, NJ)
    …cross-functional collaboration with business development, discovery, clinical development, medical affairs , regulatory , market access and key countries.- ... a sustainable innovation engine for the coming decade. The Director , Global Marketing Immunology Pipeline development is a key...Collaborate with medical affairs teams to develop robust scientific communications… more
    HireLifeScience (03/16/24)
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