• Senior Manager US Medical Affairs

    Job Locations US-NJ-Princeton
    Requisition ID
    2018-10306
  • Responsibilities

    The Sr. Manager US Medical Affairs – Renal supports Director Medical Affairs to provide Medical Affairs support for OAPI’s US Renal franchise.

    Renal Product Commercialization and Development

    • Serves as member of brand team for Otsuka Renal products. 
    • Provides medical input to all aspects of product development and promotion across the entire product lifecycle.
    • Support the execution of medical affairs strategic plan for Otsuka products
    • Review medical content of promotional materials for accuracy as part of promotional review committee 
    • Identify and develop relationships with external consultants, KOLs, investigators and vendors
    • Participate in extramural conferences and scientific meetings to maintain awareness of research in the field.
    • Applies strategic intent of OAPI when working with FDA, opinion leaders, prescribers and consumers of OAPI products
    • Manage and execute publication plan for Otsuka products as needed
    • Manage Investigator Sponsored Trials as needed

    In-house Customer Support

    • Provide content resources to Field Medical Affairs consistent to Medical Affairs strategy 
    • Coordinate with sales management to provide training to sales staff.
    • Keep abreast of current state-of-the-art developments relating to in-house medical program focus, and provide education to clinical staff and other project team members, as needed.
    • Serve as a source of medical expertise on Otsuka clinical trials for in-house customers

    Medical Information and Grants Support

    • Provide direction for medical information specialists. 
    • Provide technical assistance to medical information specialists.
    • Review grant requests as needed

    Travel (approximately 20%)

    Qualifications

    • Master’s degree with significant relevant pharmaceutical industry experience. M.D. degree of a recognized school of medicine, PhD, or PharmD preferred with + 2 years’ experience in pharmaceutical industry Medical Affairs specifically for Renal products
    • Pharmaceutical industry experience in Medical Affairs or Clinical Development (+ 4 years’ experience) for renal products would also be considered.
    • Excellent communication and interpersonal skills
    • Good knowledge of OPDP promotional regulations and pharmaceutical promotion standards
    • Good knowledge of CDER/CBER regulations regarding evaluation and approval of pharmaceuticals

    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.

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