• Mgr Document Management

    Job Locations US-NJ-Princeton
    Requisition ID
    2018-10391
  • Responsibilities

    Coordinates the Controlled Document administration across Global Quality units and affiliates and business partners to drive the creation, maintenance, tracking and training of Global Controlled GxP Documents. Provides project management of activities identified for the controlled document management and other Global Quality initiatives requiring global coordination to achieve tangible and timely results and desired outcomes. . The incumbent must be able to act independently to provide project support and guidance on a wide range of subjects across affiliates and regions within the Otsuka network. This role will support innovative initiatives and process improvement plans as needed.

    Key Job Responsibilities:

    • Provides Global coordination and project management of Global Quality activities and initiatives as assigned with initial focus on the controlled documents and innovative initiatives. 
    • Provides Project management for global tasks as assigned by the Head of Global Quality and members of the GQ leadership.
    • Schedules, tracks progress, and reports on the goals, achievements, and action items for assigned projects.
    • Develops timelines and presentations in collaboration with the team leads.
    • Responsible for maintaining and updating project plans, meeting minutes, presentations, and associated documentation.
    • Reports progress of assigned projects to GQLT and Head of GQ as requested. 
    • Serve as a member of the Global Controlled Document Management team to perform tasks as assigned by the pillar lead.
    • May serve as a team member on various Global Quality projects and initiatives. 
    • Maintains flexibility and willingness to perform other duties as required.

    Qualifications

    Required:

    • Bachelor’s Degree (BA/BS) or higher
    • 2+ years of experience in Pharmaceutical and/or controlled documentation experience
    • Knowledge of applicable clinical, nonclinical and US regulatory requirements, GxP terminology, and documentation
    • Demonstrated electronic document management systems use. Detail oriented
    • Understand data integrity controls for GxP documents
    • Advanced computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint and Outlook)
    • Drive for and practical understanding of innovation technologies
    • Excellent communication and interpersonal skills
    • Strong organizational skills
    • Willingness to work non-traditional hours to support global affiliates, particularly the Asia region.

    Preferred:

    • Demonstrated proficiency of GxP terminology

    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 a youthful spirit of 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 45,000 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.

    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

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