• Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …with respect to impact development programs. Additionally, this position interacts with Regulatory Affairs (RA) team members, cross-functional team members, FDA ... Experience in the pharmaceutical industry7 or More Years with direct regulatory affairs experienceManagerial experience preferredExperience with ex-US … more
    HireLifeScience (05/07/24)
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  • Aequor (Newbury Park, CA)
    …Support the implementation of Veeva Vault, IDMP, EU CTR, and other regulatory initiatives. Work with stakeholders to gather requirements and develop solutions. ... Provide Subject Matter Expertise in Veeva Vault Configuration and Regulatory Processes to a global user base. Develop and deliver training materials and… more
    HireLifeScience (05/01/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …As a result, this role will need to partner closely with teams and senior leaders from across Regulatory Affairs , as well as cross-functional ... Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, reporting, and… more
    HireLifeScience (05/05/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …personnel in other departments including Marketing, CMR, Legal, and counterparts in NNAS Regulatory Affairs . Has a positive approach to work projects and ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
    HireLifeScience (05/07/24)
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  • Eisai, Inc (NJ)
    …key business processes. Responsible for approval of medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs and Commercial ... profile, we want to hear from you. The Medical Director, US Medical Affairs provides medical leadership for medical affairs strategy, planning and supportive… more
    HireLifeScience (04/26/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …program and content, and field alignment directors. They will also be the senior strategic representative of medical affairs in the relevant therapy area ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...& evidence team and other relevant functions As a senior level representative of medical affairs , the… more
    HireLifeScience (04/12/24)
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  • Arthrex (Naples, FL)
    …Arthrex is actively searching for a Sr. Project Manager, Program Manager - Regulatory Affairs who is responsible for managing and resolving issues related ... Manages subsidiary-based and global projects/programs within the scope of the Regulatory Affairs . Develops project objectives by reviewing project proposals… more
    JobGet (04/29/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …activities and ways of working. This role will also work with the Global Regulatory Affairs Leadership Team (GRA-LT) to define DS' priorities, strategy and ... MD, JD preferred Experience Qualifications7 or More Years Experience in pharma Regulatory Affairs , with at least 3 years developing regulatory strategies… more
    HireLifeScience (04/23/24)
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  • Eisai, Inc (Nutley, NJ)
    …hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning and supportive tactics mainly for GU therapeutic area. This ... working with key stakeholders to develop and execute the medical affairs plan, including data generations (including RWE), post-marketing research, medical… more
    HireLifeScience (04/26/24)
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  • Reynolds Consumer Products Inc. (Lake Forest, IL)
    …rapidly evolving legislation, and regulation of consumer-packaged goods and the environment.Assist the Senior Regulatory Counsel and Senior Regulatory ... have: High school diploma or equivalent.2-5 years' experience working in regulatory compliance or regulatory affairs for a consumer products, food, beverage,… more
    JobGet (04/30/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …creation of developmental and regulatory strategy in collaboration with Regulatory Affairs ; Drafts clinical development plans, protocol profiles and sections ... indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; Represents clinical… more
    HireLifeScience (05/09/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …the Product Material Review Team (PMRT) with the Legal, and Medical Affairs departments, ensuring consistency of materials across brands and departments, adherence ... cross functional assistance for PGC, Learning Management System (LMS) and Regulatory , as needed. ResponsibilitiesEditorial Review of Materials Review and consult… more
    HireLifeScience (04/27/24)
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  • Merck & Co. (North Wales, PA)
    …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.- Specifically, the Senior Director… more
    HireLifeScience (04/30/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …with cross functional teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical Operations, ... The Associate Director, RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small… more
    HireLifeScience (03/01/24)
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  • Merck & Co. (Rahway, NJ)
    …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May… more
    HireLifeScience (05/04/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …creation of developmental and regulatory strategy in collaboration with Regulatory Affairs ; Drafts clinical development plans, protocol profiles and sections ... indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; Represents clinical… more
    HireLifeScience (03/01/24)
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  • Merck & Co. (South San Francisco, CA)
    …reports. Interact with colleagues from multiple areas, including discovery, regulatory affairs , project teams, and development functions.Partner with ... DescriptionJob Responsibilities:Primary responsibility is writing and preparing nonclinical pharmacology regulatory document submission sections and study reports to support… more
    HireLifeScience (05/02/24)
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  • Fidelity TalentSource LLC (Boston, MA)
    …team is part of the Associate and Leadership Communications organization within Corporate Affairs . Working closely with the most senior leaders within the ... Job Description:The RoleAs a Senior Communications Manager for Fidelity Wealth, you will...areas of accuracy, ethics, legal, and complianceWorking across Corporate Affairs and with business partners (eg, HR, Strategy &… more
    JobGet (05/09/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 30% overnight travel required. Position can ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...instances, at the discretion of Executive Director of Medical Affairs . Assists the Senior Medical Director in… more
    HireLifeScience (05/07/24)
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  • Eisai, Inc (Nutley, NJ)
    …Functions Medical Affairs Strategic Plans: Under the direction of the Senior Medical Director, work with key stakeholders, management, and functional area leads ... for assigned therapeutic area. Under the direction of the Senior Medical Director, this role will be responsible for...Responsible for approval of medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs more
    HireLifeScience (04/26/24)
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