• Merck & Co. (Rahway, NJ)
    Job DescriptionThe Regulatory Project Manager (RPM) is a key member of our company's Regulatory Planning and Publishing (RPP) organization, which operates within ... the larger framework of Global Regulatory Affairs, Clinical Safety, and Pharmacovigilance (GRACS), Operations, Process, & Systems (GRACS OPS). The RPM role sits in… more
    HireLifeScience (03/23/24)
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  • 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
    HireLifeScience (03/28/24)
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  • 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
    HireLifeScience (03/28/24)
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  • Merck & Co. (North Wales, PA)
    Job DescriptionJoin our team as the Associate Director , Educational Engagement Innovation Accelerator and be at the forefront of revolutionizing medical ... meet the needs of HCPs to treat and care for their patients.As the Associate Director , Educational Engagement Innovation Accelerator, you will be a key… more
    HireLifeScience (03/27/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual ... will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support...of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines… more
    HireLifeScience (03/19/24)
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  • Merck & Co. (North Wales, PA)
    …/Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the review and approval of all US ... promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional practices are consistent… more
    HireLifeScience (03/01/24)
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  • Merck & Co. (Rahway, NJ)
    …Quantitative Pharmacology and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Associate Director QP2-IO team is part of the Global Clinical ... of drug development and effective communication skills. As a subject matter expert, the Associate Director within the QP2-IO Group will work closely with teams… more
    HireLifeScience (03/26/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …independently in order to accomplish objectives. Relationships Reports to the Director , Patient Support Programs Rare Disease. Key internal relationships include ... commercial insights and analytics, sales, medical/CMR, legal, compliance, and regulatory . Other internal relationships include Public Affairs, Government Affairs &… more
    HireLifeScience (03/27/24)
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  • Merck & Co. (Millsboro, DE)
    Job DescriptionPosition Description: Associate Director - Site Digital Technology Lead The Site Digital Technology Lead is the representative for Global Animal ... maintained, and that all operational activities are compliant with regulatory , safety, cyber-security, business continuity and financial requirementsLeadership of… more
    HireLifeScience (03/22/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI, annotated labeling, medication guides, EU… more
    HireLifeScience (02/23/24)
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  • Merck & Co. (Rahway, NJ)
    …a member of the Medical Device Combination Products Quality QMS group, the Associate Director , will participate in and/or lead various initiatives in support ... every aspect of our business processes, systems, and data. - The Associate Director will collaborate and interact with cross-functional and cross-divisional… more
    HireLifeScience (03/16/24)
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  • Merck & Co. (North Wales, PA)
    …trial team.Collaborates with the Medical Writer on clinical/scientific and regulatory documents.Partners with Study Manager on study deliverables.Participates in the ... of clinical data/medical protocol-deviations in collaboration with the Clinical Director .Builds talent and capabilities of direct/indirect team members through… more
    HireLifeScience (03/22/24)
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  • Merck & Co. (Rahway, NJ)
    Job DescriptionThe Associate Director , Clinical Supply Operations (CSO) within Global Clinical Supply (GCS) is responsible for supporting launch and subsequently ... processes, as well as business continuity.Key responsibilities of the Associate Director , Clinical Supply Operations include:Supporting the implementation… more
    HireLifeScience (03/15/24)
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  • Merck & Co. (North Wales, PA)
    …development).The HCP Strategy lead will work closely with the HIV US Commercial director as part of the overall brand marketing team and will report directly ... drive and align on decisions, including field sales, marketing operations, Legal, Regulatory , Medical, etc.Our US marketing team has adopted an Agile operating model… more
    HireLifeScience (03/19/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …team in the Global Oncology Value, Access, and Pricing (GOVAP) department. The Associate Director , Global Oncology RWE Generation will report directly to the ... as well as building and retaining institutional memory within Daiichi Sankyo. The Associate Director , Global Oncology RWE Generation will work in close… more
    HireLifeScience (03/12/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …areas centered around rare diseases and immune disorders. SUMMARYThe Associate Director , Pharmacoepidemiology position provides epidemiologic, methodological, ... study protocols.This position independently manages relationships with internal (CSPV, Regulatory , Clinical, Medical Affairs, HEOR and other stakeholders to ensure… more
    HireLifeScience (03/14/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... individual due diligence activitiesThis CRS will focus mostly on pediatric regulatory documents and the execution of pediatric clinical trials. Qualifications:… more
    HireLifeScience (03/21/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …as other research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for ... for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data, authoring CMC… more
    HireLifeScience (03/01/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …possesses advanced knowledge of clinical operations and processes and relevant regulatory requirements. This position has experience working on Phase I-IV study ... and/or pharmaceutical industry across multiple therapeutic areas and experience with regulatory submissions and inspections. Finally, this position has strong skills… more
    HireLifeScience (03/16/24)
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  • Merck & Co. (North Wales, PA)
    …drive and align on decisions, including global communications, marketing operations, Legal, Regulatory , Medical, etc. Our US marketing team has adopted an Agile ... operating model to be more adaptive and responsive to rapidly evolving customer needs and keep pace with the digital evolution in the marketplace. This Agile model enables marketers to enhance their experience, building skills and capabilities that flex across… more
    HireLifeScience (03/19/24)
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