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    Head of Project Management - New Jersey, United States - Daiichi Sankyo, Inc.

    Daiichi Sankyo, Inc.
    Daiichi Sankyo, Inc. New Jersey, United States

    3 hours ago

    Daiichi Sankyo, Inc. background
    Description
    Join a Legacy of Innovation 110 Years and Counting

    Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally 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 its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new 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 focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

    This position is responsible for clinical label development support for all Daiichi-Sankyo led clinical trials requiring Clinical Trial Material (CTM) and will also serve as the Subject Matter Expert (SME) for the SaaS and cloud-based label phrase library, working collaboratively with the CSO Program Managers to identify and meet delivery dates for clinical labels to our CMO's and internal packaging sites for GMP processing operations.

    This position will work with a label translation company to supplement the phrase library as required and will work with the CSO Continuous Improvement function to establish industry-leading label development process that incorporates global regulatory requirements while incorporating flexibility and simplicity in the design of clinical labels.

    Manage end to end label development process for assigned projects / clinical studies in close collaboration with CSO PM's.

    Develops label templates within label phrase library to accelerate label development timelines and improve Quality.

    Monitors label printing vendor key performance metrics and collaborates with internal stakeholders and vendors to address project challenges as needed.


    • Manage label translation vendor(s) to supplement regulatory compliant label text not present within the phrase library.
    • Collaborate with CSO Continuous Improvement to propose industry leading process improvements designed to reduce cycle times, improve Quality and decrease costs. Bachelor's Degree In pharmacy, biochemistry, (bio) chemical engineering, chemistry, or other discipline within pharmaceutical/biotechnology sciences or related field required
    • 4 + years of related experience related experience, including IT/system management in Pharmaceutical Development / Clinical research, and Project Management required
    • 1+ years of experience in the development of parenterallydelivered oncology drugs Travel
    Ability to travel up to 10% Overnight/single-day travel will be required. Communications (electronic and teleconference/videoconferencing) across all global time zones, global and domestic travel required.

    Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

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