• Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …centered around rare diseases and immune disorders. Summary The Manager, Regulatory Affairs - Regulatory Project Management (RPM) provides planning and ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...coordination supports for global and US regulatory activities. The Manager RPM is responsible for supporting… more
    HireLifeScience (03/26/24)
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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 ... company's growth, thereby accomplishing corporate goals.ResponsibilitiesDevelop and implement US regulatory strategy for assigned project (s).Strategize and plan… more
    HireLifeScience (03/19/24)
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  • 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 ... global project team meetings (development and/or marketed products); provide regulatory support and guidance and manage day-to-day regulatory activities.… more
    HireLifeScience (03/03/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    regulatory strategy for assigned development projects. Represents Daiichi Sankyo's regulatory group in internal and external development project meetings. ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
    HireLifeScience (03/01/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …disclosure for collection, retention, testing and retesting of samples Project Team Participation: Provide device-specific regulatory insight/guidance during ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
    HireLifeScience (03/01/24)
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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 ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...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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  • Astellas (Westborough, MA)
    …II, Analytical Development Senior Project Manager, Technical Operations Senior CMC Regulatory Affairs Manager, Cell/Gene Therapy Manager CMC Regulatory ... thinking and day-to-day decision-making. We focus on addressing unmet medical needs and conduct our business with ethics and...Affairs , Gene Therapy Associate Director CMC Regulatory Affairs , Gene Therapy Developing innovative therapies… more
    HireLifeScience (01/14/24)
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  • Eisai, Inc (Nutley, NJ)
    …used to develop solutions and drive best practices within Scientific Communications and Medical Affairs .Drive oversight, project management and delivery of ... and management of digital strategy, effectiveness and innovation initiatives supporting US Medical Affairs and Research & Development. The person in this… more
    HireLifeScience (02/07/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …Provides global strategic support and leadership to other functions such as Clinical, QCP, BDM, Regulatory Affairs and Medical Affairs in all aspects of ... RD globally, as well as global Medical Affairs , as applicable.- Sets global standards for regulatory...geographical regions, based on current and future workload and project priorities, based on Daiichi Sankyo's product portfolio and… more
    HireLifeScience (03/01/24)
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  • Merck & Co. (North Wales, PA)
    …requirements. In the clinical arena, RDH works with key functional groups within Global Regulatory Affairs , GCTO and others to implement the regulatory ... Work Experience Experience/Skills We are Looking for: Minimum:-Bachelor's Degree in Regulatory Affairs , Quality Assurance, Clinical Affairs ,… more
    HireLifeScience (02/28/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …including veterans and people with disabilities.SummaryThis position leads the Global Regulatory Affairs (GRA) Global Labeling function, combining knowledge of ... global and regional leaders from Supply Chain, Clinical Safety Pharmacovigilance, Commercial, Medical Affairs and Legal) to ensure accurate and high-quality… more
    HireLifeScience (02/23/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …Internal relationships include working with Headquarters, NA CMR including Clinical Trial Management, Medical Affairs , Regulatory Affairs and other NNI ... About the Department The Clinical, Medical and Regulatory (CMR) department at...Assure timely initiation of studies; act as liaison with Regulatory , project teams, and investigators. Support recruitment… more
    HireLifeScience (03/15/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …of the Product Material Review Team (PMRT) and as a member of the Medical Affairs product team(s) for the assigned TA.Responsibilities- Ensure timely and ... reviewer and/or team lead- Serve as member of the Medical Affairs Teams for assigned TA. Ensure...data and promotional content within the assigned therapeutic area. Regulatory milestones, actions and guidance relevant to medical more
    HireLifeScience (03/20/24)
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  • Novo Nordisk Inc. (Chicago, IL)
    …priorities and business needs. Relationships This position may report into the Field Director, Medical Affairs (or in smaller TA's directly into the TA head). ... About the Department The Clinical, Medical and Regulatory (CMR) department at...for scientific resources, communications, and training initiatives for the medical affairs team Serve on Clinical Trial… more
    HireLifeScience (03/20/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …directly to the Vice President, Clinical Data Science & Evidence (CDSE) in Clinical, Medical and Regulatory Affairs (CMR) and has broad responsibility for ... About the Department The Clinical, Medical and Regulatory (CMR) department at...with vendors, global RWD and IT teams, clinical teams, medical affairs , and customers to execute on… more
    HireLifeScience (03/18/24)
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  • Merck & Co. (Rahway, NJ)
    …of labeling experience or relevant experience in the pharmaceutical industry (eg, Medical Affairs , Regulatory Affairs , Clinical, Pharmacovigilance).- ... CCPPI, CCIFU) and US labeling for marketed products; and supporting country Regulatory Affairs in the development and maintenance of the EU Labeling and other… more
    HireLifeScience (03/02/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …minutes.- Works with cross functional teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical ... changes for portfolio biologics and determines filing strategies, provides expertise as regulatory CMC representative to project teams, and supports change… more
    HireLifeScience (03/01/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …for this role include Regional HEOR/RWE and Market Access teams, Global Oncology Medical Affairs (GOMA) and its relevant functions, R&D, Digital Intelligence ... members from other departments such as Regional HEOR/RWE and Market Access, Global Medical Affairs , RD, and Digital Intelligence to maintain communication on key… more
    HireLifeScience (03/12/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    Regulatory /Risk Management, Quality Assurance, Medical Affairs , Translational Research, Research, Informatics Services Project Management ... include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs , Quantitative Clinical Pharmacology, Clinical Safety… more
    HireLifeScience (03/06/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs , etc. Qualifications: Successful candidates will be ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
    HireLifeScience (03/02/24)
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