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    Director, Medical Innovation - New Jersey, United States - Daiichi Sankyo, Inc.

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

    1 week 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.

    Drive medical and operational compliance standards as the Center of Excellence (CoE) lead for the business implementation across all key Global Oncology Medical Affairs (GOMA) activities, in close collaboration with cross-functional and regional stakeholders.

    Develop and ensure execution of an effective and efficient GOMA CoE Risk Management Plan (RMP) and support conduct oversight.

    Assess CoE compliance risks and operational support, in conjunction with key stakeholders (Legal, Compliance, Quality Assurance (QA) and Medical Affairs Subject Matter Experts) across functions, geographies and levels of the organization.

    CoE Risk Management Plan (RMP) and operational oversight:
    In partnership with QA and other relevant stakeholders across line functions, geographies and levels of the organization, establish a systemic GOMA CoE RMP process to identify, evaluate, prioritize, mitigate and monitor risks and support
    Ensure proper end-to-end documentation focusing on operational effectiveness and efficiency by building and maintaining a repeatable and standardized GOMA CoE process
    Help drive the operational execution of the GOMA CoE RMP process and proactively manage the resource model and timelines

    • Manage and establish a GOMA CoE Audit Inspection Plan in partnership with QA and relevant stakeholders across functions, geographies and levels of the organization
    Ensure proper end-to-end documentation focusing on operational effectiveness and efficiency by building and maintaining a repeatable and standardized process
    Lead and/or direct activities to support GOMA CoE team during preparation, conduct and closure of in partnership with relevant stakeholders

    • Contribute to the development and support with operational execution of a sustainable document Life Cycle Management (LCM) process for proposing, developing, reviewing, approving, training, distributing and archiving of global procedural documents for Medical Affairs (MA) activities, as applicable
    Support the GOMA CoE process for assignment and tracking of required and supplemental trainings in the Learning Management System (LMS)Establish maintain effective communication channels to raise awareness of GOMA CoE compliance-related matters across MA
    Bachelor's Degree in Science, Pharmacy, Medicines or Business Administration required Experience Qualifications

    • 10 or More Years of experience in pharma at local, regional and/or global level preferred
    • Strong knowledge on operational aspects of medical affairs activities preferred
    • Knowledge and/or experience in leading medical affairs oversight & governance activities preferred
    • Strong change management skills to drive and sustain a culture of high ethical standards and compliance required
    • Considerable organizational awareness, including experience working across functions and geographies to achieve high performance required
    • Display enterprise leadership by building strong internal and external relationships with diverse stakeholders that maximize alignment and organizational effectiveness required
    • Expertly manage ambiguous and highly complex situations required
    • Effectively manage oversight of different and diverse activities (clinical program, publication, medical education, Advisory boards) preferred
    • 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.
  • Daiichi Sankyo, Inc.

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