• Associate Director/Director Promotional Compliance

    Job Locations US-NJ-Princeton
    Requisition ID
    2018-10493
  • Responsibilities

    Directs or assists staff member(s) or independently reviews, revises and approves content and context required of promotional materials for prescription drug and drug-device products
    Utilizes regulatory knowledge to provide support and strategic input in structuring promotional claims. Ensures that promotional and training materials meet regulatory and company requirements. Must be effective in managing work and resolving conflicts. Must deal with ambiguity and be action oriented.
    Must demonstrate a high level of understanding of product labeling and promotion compliance. The ideal candidate should demonstrate a high level of understanding in both disciplines.
    May be assigned additional responsibilities as deemed necessary.

     

    • Supervises direct and indirect report(s) or acts to ensure all promotional materials are in compliance with relevant laws and regulations. Analyses and interprets new regulations and Guidances as well as monitors and determines the impact of the Office of Prescription Drug Promotion (OPDP) correspondences and enforcement actions (e.g., WARNING Letters).
    • Supervises direct and indirect report(s) or reviews promotional and commercial communication materials to ensure that the information conveyed is consistent with the product labeling and is suitable for their intended audience and use. Provides alternative suggestions to allow for consistent messaging.
    • Supervises direct and indirect report(s) or reviews promotional and commercial communication materials to ensure that the information conveyed is consistent with the product labeling and is suitable for their intended audience and use. Provides alternative suggestions to allow for consistent messaging.
    • Responsible for final review and approval of promotional and sales training materials, and corporate communications, as appropriate. Ensures product promotional materials are submitted to OPDP on Form FDA 2253 in a timely manner as per regulations, and that materials are archived as per company policy.
    • Monitors and informs others of changes in US labeling and promotional regulations as well as corporate policies and procedures, as appropriate. Utilizes these changes in modifying company procedures.
    • Develops and designs improvements to policies, processes, quality, and system tools. Manages contracts for contractors and consultants as appropriate.
    • Attends cross functional teams: Global Regulatory Team (GRT), Global Labeling Team (GLT).
    • Provides training to OAPI/OPDC employees on regulations for promotion compliance as appropriate.
    • Acts as liaison between the company and OPDP. Arranges and leads meetings with OPDP as appropriate.

    Qualifications

    Required:


    • Solid interpretation of US regulatory requirements
    • Well versed in clinical medicine and clinical pharmacology
    • Excellent understanding of medical concepts and terminology
    • Solid understanding of the structure and function of the product labeling
    • Solid understanding of the pharmaceutical industry drug development process

     

    Preferred:


    • Able to work across multifunctional groups
    • Strong written and oral communication skills
    • Strong computer skills including experience with Veeva PromoMats, MS Office: Word, Excel, PowerPoint, and Outlook and Adobe products
    The ideal candidate should be action oriented, customer focused, can manage workloads, set priorities, and have demonstrated the ability to build effective teams. In addition, he/she should be capable of dealing with ambiguity, be creative, be comfortable working with multifunctional teams and show strong business acumen.
    Education and Experience
    Required:
    • Bachelor’s Degree and 8+ years of experience in promotional pharmaceutical compliance and product labeling
    Preferred:
    • JD, MD, MS, PhD, or Pharm D and 4+ years of experience in promotional compliance and product labeling in the pharmaceutical industry

    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.

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