• Associate Director Global R&D Clinical IT Business Information

    Job Locations US-NJ-Princeton
    Requisition ID
    2019-10912
  • Responsibilities

    The Associate Director – Global R&D Clinical IT Business Information will partner with the business functions to anticipate, capture, and build business cases for the adoption of R&D systems for EDC, CTMS, Clinical Studies’ Data, Pharmacovigilance, Wearable, Digital, Cloud, and software development to enhance Otsuka’s R&D capabilities.

     

    • Leverage the platform, infrastructure, project management, application support, and corporate security functions within OIT to assess and select COTS and or software development team teams to enable R&D capabilities.
    • Work with stakeholders at all levels of the organization in a global, matrixed, multi-cultural, collaborative environment to evaluate cost-benefit analyses and the total cost of ownership for enabling capabilities. 
    • Drive business and technical requirements analysis, business process modeling/mapping, methodology development, and data modeling efforts to support Otsuka’s clinical trials.

    Qualifications

    • Minimum Bachelor’s degree is required. Degree in Life Sciences, Computer Science, Engineering or Business preferred.  Advanced degree preferred
    • Minimum 7 yrs. IT experience is required
    • Experience in pharmaceutical R&D, Medical Affairs, and or Regulatory Affairs is preferred.
    • Supervisory experience in a global, matrixed, multi-cultural, collaborative environment is preferred.
    • Knowledge of FDA regulations, including 21 CFR Part 11, quality standards, ICH guidelines, including GCP, GLP and GAMP is required.
    • Strong analytical and technical skills for mapping clinical trials and or R&D needs to create plan for alignment and implementation of IT solutions is required.
    • Overseeing the strategy for designing, developing, and implementing software and hardware solutions, systems, or IT products within Pharmaceutical or Biotechnology R&D is required.
    • Ability to build strong relationships with stakeholders, work with people at all levels of the organization, and working in a global, matrixed, multi-cultural, collaborative environment.
    • Up to 10% domestic and international travel is required based upon business needs.

    Overview

    Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.


    In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying creativity in everything it does.


    Otsuka Pharmaceutical Company is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 50,000 people worldwide and had consolidated sales of approximately USD 11 billion (€ 9.9 billion) in 2016.

    All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical Company on its global website at
    www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com.

    Disclaimer:

    This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

    Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

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