Manager Labeling and Promotion Compliance
Otsuka - Princeton, NJ

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Job Description-Overview • Works with supervisor to review, revise, and approve content and context that are required for development and maintenance of labeling components. Provides strategic input in structuring labeling components, and ensures that labeling materials meet regulatory and company requirements. Can deal with ambiguity and must be action oriented.

  • Works with supervisor to Reviews, revises and approves content and context required of promotional labeling materials for prescription drug and medical products. Ensures that promotional labeling and training material meet regulatory and company requirements.
  • The candidiate must demonstrate an understanding of of labeling or promotion compliance. The ideal candidate should demonstrate an understanding of both disciplines.
  • May be assigned additional resposibilities as deemed necessary
Qualifications Key job responsibility
Ensures all promotional and labeling materials are in compliance with relevant laws and regulations.

Participates and provides strategic advice in labeling meetings for development of promotional messages, and implementation of new regulations.

Provides review of 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 conistent messaging.

Responsible for final review and approval of promotional and sales training materials, and corporate communications. Ensures product promotional materials are submitted to Division of Drug Marketing, Advertising, and Communication (DDMAC) on Form FDA 2253 in a timely manner as per regulations, and that materials are archived as per company policy.

Monitors changes in US labeling and promotional, regulations as well as corporate policies and procedures. Informs and updates team members, as appropriate

Recommends improvements to labeling policies, processes, quality, and system tools.

Chairs cross functional teams: Labeling Committee, Labeling Team, and Product Review Council teams.
Provides training to OAPI/OPDC employees on regulations for labeling and promotion compliance as appropriate.
Acts as liaison between the company and DDMAC. Arranges and leads meetings with DDMAC as appropriate.

Required :
  • Knowledge of US regulatory requirements
  • Knowledge of clinical medicine and clinical pharmacology
  • Basic Knowledge of medical concepts and terminology
  • Basic Knowledge of the structure and function of the product labeling
  • Fundamental Knowledge 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 MS Office: Word, Excel, PowerPoint, and Outlook, and Adobe products: Acrobat, InDesign and Illustrator.
The ideal candidate should be action oriented, customer-focused and have the ability to manage work loads. In addition, he/she should be capable of dealing with ambiguity, be creative and be comfortable working with multifunctional teams.
Physical Demands and Work Environment

Travel (approximately 10%)
Education and Related Experience

  • Bachelor's Degree and 2+ years of experience in promotional pharmaceutical compliance and product labeling
  • MD, MS, PhD, or Pharm D and 1+ years of experience in promotional compliance and product labeling in the pharmaceutical industry
About Otsuka Otsuka America Pharmaceutical, Inc. (OAPI) is a successful, innovative, fast growing healthcare company that commercializes Otsuka-discovered and other product opportunities in North America, with a strong focus on and commitment to neuroscience, cardiovascular and oncologic therapeutic treatments. OAPI is dedicated to improving patients' health and the quality of human life.

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About this company
Otsuka America is the holding company for the US operations of Japan's  Otsuka Pharmaceutical. Otsuka America oversees pharmaceutical...