Associate Director Promotion Compliance

US-NJ-Princeton
Requisition ID
2017-9890

Responsibilities

  • Directs or assists junior staff member(s) or independently reviews, revises, and approves content and context that are required for development and maintenance of the promotional package insert. Utilizes regulatory knowledge to provide support and strategic input in structuring the product labeling components, and ensures that promotional labeling materials meet regulatory and company requirements, and timelines. Must deal with ambiguity and be action oriented.
  • Directs or assists junior staff member(s) or independently reviews, revises and approves content and context required of promotional labeling materials for prescription drug and/or medical device products. Ensures that promotional labeling and training material meet regulatory and company requirements. Must be effective in managing work and resolving conflicts.
  • The candidiate must demonstrate a high level of understanding of promotion compliance. The ideal candidate should demonstrate a high level of understanding product labeling and FDA regulations as it pertains to promotion.

May be assigned additional resposibilities 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 Office of Prescription Drug Promotion (OPDP) correspondence and WARNING Letters.

 

Supervises direct and indirect report(s) and/or participates in the development and maintenance of promotional labeling components, and provides strategic advice in labeling meetings for development of promotional messages, and implementation of new regulations.

 

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 DDMAC 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.

 

Recommends improvements to labeling policies, processes, quality, and system tools. Manages contracts for contractors and consultants.

 

Attends and participates in cross functional teams meetings including: Global Regulatory Team (GRT) and 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:

                   Bachelor’s Degree and 6+ years of experience in promotional pharmaceutical compliance and product labeling

    • Solid understanding of US regulatory requirements
    • Broad knowledge of clinical medicine and clinical pharmacology
    • Excellent understanding of medical concepts and terminology
    • Solid understanding of the structure and function of the product labeling
    • Fundamental understanding of the pharmaceutical industry drug development process

 

Preferred:

  • MD, MS, PhD, or Pharm D and 3+ years of experience in promotional compliance and product labeling in the pharmaceutical industry
  • Able to work across multifunctional groups
  • Strong written and oral communication skills
  • Good computer skills including experience with MS Office: Word, Excel, PowerPoint, and Outlook and Adobe products: Acrobat, InDesign and Illustrator.

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 can deal with ambiguity, be creative, be comfortable working with multifunctional teams and show strong business acumen.

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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