• Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …around rare diseases and immune disorders.Summary The Director , Head of Global Dossier Planning, Regulatory Operations is responsible for leading the dossier ... Director of Dossier Planning will ensure high quality regulatory submissions to health authorities including but not limited... of Dossier Planning will report to Head of Global Regulatory Operations and be an active… more
    HireLifeScience (03/25/24)
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  • Merck & Co. (Rahway, NJ)
    …Publishing (RPP) organization, which operates within the larger framework of Global Regulatory Affairs, Clinical Safety, and Pharmacovigilance (GRACS), ... The RPM plays a crucial role in guiding and advancing projects by translating global regulatory strategy into actionable plans at the asset level. This… more
    HireLifeScience (03/23/24)
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  • Merck & Co. (North Wales, PA)
    …We strive to foster an environment that is inspiring, supportive, and diverse.The Director , Commercial & Regulatory Legal provides legal support to our Human ... initiatives in support of business activitiesCommercial contractingRelated liability and regulatory issuesSupervising activities and managing relationships with outside counselQualifications:… more
    HireLifeScience (03/23/24)
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  • Merck & Co. (Rahway, NJ)
    Job DescriptionWe are currently recruiting for a Director Global Oncology Marketing- Hematology Asset & Disease Lead - for new Antibody Drug Conjugates which is ... commercial input on such activities as: target product profile development, global regulatory filing strategy, launch readiness reviews, organized customer… more
    HireLifeScience (03/26/24)
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  • Merck & Co. (North Wales, PA)
    …corporate standards and policies and business objectives.Actively- participate in labeling and global regulatory team meetings to ensure support for anticipated ... 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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  • Merck & Co. (North Wales, PA)
    …, Regulatory Affairs Liaison, is responsible for development and implementation of global regulatory strategy for their assigned projects in the Vaccines and ... with the Worldwide Regulatory Agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more of our… more
    HireLifeScience (03/01/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure ... all disciplines within the Daiichi Sankyo organization to obtain and/or provide information /data for regulatory filings.May serve as the single regulatory more
    HireLifeScience (03/03/24)
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  • Merck & Co. (North Wales, PA)
    Job DescriptionWe are currently recruiting for an Executive Director , Oncology Portfolio Strategy, Global Market Access -Our Oncology access team is dedicated to ... on innovation that help people with cancer across the globe.-The Executive Director will develop the oncology multi-asset, multi-indication access end to end… more
    HireLifeScience (03/16/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …the Global Oncology Value, Access, and Pricing (GOVAP) department. The Associate Director , Global Oncology RWE Generation will report directly to the ... as building and retaining institutional memory within Daiichi Sankyo. The Associate Director , Global Oncology RWE Generation will work in close collaboration… more
    HireLifeScience (03/12/24)
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  • Merck & Co. (Rahway, NJ)
    …our position as a sustainable innovation engine for the coming decade. The Director , Global Marketing Immunology Pipeline development is a key leadership role ... advanced analytics into launch planning, ensuring alignment with market needs & regulatory requirements. By exemplifying our inclusive ways of working, you will… more
    HireLifeScience (03/16/24)
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  • Merck & Co. (North Wales, PA)
    …are seeking a highly experienced and dynamic individual to join our team as the Global Director HIV Marketing. In this role, you will be responsible for leading ... of successfully launching and commercializing pharmaceutical products.Deep understanding of the global HIV treatment market and familiarity with regulatory and… more
    HireLifeScience (03/08/24)
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  • Merck & Co. (North Wales, PA)
    …DescriptionWe are currently seeking a highly motivated and experienced US Oncology Portfolio Director to join our Pipeline and Portfolio Strategy Team in the US ... Human Health Oncology division. The Portfolio Strategy Director is responsible for developing and implementing portfolio strategies for the oncology pipeline and… more
    HireLifeScience (03/27/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... strategy closely aligned with the business strategy within one or more Global Project Team(s) (GPT) within Oncology Development Franchises or Business Units. Provide… more
    HireLifeScience (02/24/24)
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  • Merck & Co. (Rahway, NJ)
    …endpoints including proportional hazards models.Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics ... - Immune/Oncology (QP2-IO) team in the role of Associate Director QP2-IO team is part of the Global...in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs),… more
    HireLifeScience (03/26/24)
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  • Merck & Co. (North Wales, PA)
    …learning innovation to support both.Collaborate effectively with supporting functions, such as Global Human Health, Finance, Compliance, Legal and Regulatory to ... Job DescriptionJoin our team as the Associate Director , Educational Engagement Innovation Accelerator and be at...to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its… more
    HireLifeScience (03/27/24)
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  • Catalent (Harman, WV)
    POSITION SUMMARY The Director , Quality Systems is responsible for the management and oversight of the core quality systems, including investigation/deviation ... revision of GMP documentation such as standard operating proceduresManages regulatory (FDA, EMA) and client audits/inspections of Catalent. Responsible performing… more
    HireLifeScience (03/27/24)
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  • Eisai, Inc (Nutley, NJ)
    …is your profile, we want to hear from you. Job Summary The Associate Director , Global Medical Affairs will provide medical leadership for medical affairs ... Essential Functions Medical Affairs Strategic Plans: Under the direction of the Global Senior Medical Director , work with key stakeholders, alliance… more
    HireLifeScience (01/25/24)
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  • Merck & Co. (Rahway, NJ)
    …data integrity, security, and awareness of the latest technology in information storage and retrieval systems.The Director works cross-functionally and ... Job DescriptionPosition Description: Director , Clinical Literature MonitoringThe Director is...requirementsMaintains expertise in developments in the fields of medical information , regulatory policy, adverse event reporting,Identifies and… more
    HireLifeScience (03/22/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …to date- Support regulatory inspection related activities as required- Support Head, Global strategy and operations to develop and plan the Global QA ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
    HireLifeScience (02/07/24)
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  • Merck & Co. (Millsboro, DE)
    …11, Good Manufacturing Practices, Computer Systems Assurance, track and trace, and other global regulatory requirements that impact IT and OT systems in ... Job DescriptionPosition Description: Associate Director - Site Digital Technology Lead The Site...The Site Digital Technology Lead is the representative for Global Animal Health Manufacturing IT (GAHM IT) on the… more
    HireLifeScience (03/22/24)
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