Director - Advertising and Promotion

Highly Competitive Salary
  1. Permanent
  2. Senior/Director & VP, Officer /Associate, RA Intelligence
  3. United States
Rockville, USA
Posting date: 14 Apr 2021
RA.NW.36877

Proclinical is currently recruiting for a Director of Advertising and Promotion for a leading biotechnology company located in Rockville, MD. As the Advertising and Promotion Director, you will develop, manage, and execute global promotional strategies working in close collaboration with cross-functional teams across the organization.

Job Responsibilities:

  • Directs or assists staff member(s) or independently reviews and approves content required for advertising and promotional labeling materials and ensures promotional materials are in regulatory compliance with relevant laws and regulations as well as company policies and procedures to communicate proper use and safety of products within promotional materials.
  • Supervises direct and indirect report(s) or analyses and interprets new regulations and FDA guidance documents as well as monitors and determines the impact of Office of Prescription Drug Promotion or Advertising (OPDP) and Advertising and Promotion Labeling Branch (APLB) correspondences and enforcement actions.
  • Acts as liaison between the company and OPDP/APLB. Arranges and leads meetings and interactions with OPDP/APLB as appropriate.
  • Leads submission for advisory comments and provides strategic advice for the development of packages to be sent to OPDP or APLB as appropriate.
  • Manages review of promotional materials and sets priorities to ensure internal and external deadlines are met.
  • Identify and assist teams in overcoming barriers and finding solutions in achieving quality and compliance.
  • Communicates labeling update plans to commercial and other functional teams in a timely manner.
  • Oversee the development of any internal documents related to product labeling including but not limited to Policies, Standard Operating Procedures (SOPs) and Work Practices as needed.
  • Provides training to employees on regulations regarding advertising and promotion compliance as appropriate.
  • Facilitate cross-functional and team awareness and understanding of regulatory issues as appropriate.

Skills and Requirements:

  • Life sciences, pharmacy graduate or equivalent. Advanced academic qualifications/degree such as Pharm.D. or Ph.D. are an advantage but not essential.
  • A minimum of 12 years in the drug development industry with at least 10 years in Regulatory Affairs with focus on Advertising and Promotion expertise.
  • Proven ability to successfully understand regulatory implications of product strategy with regards to the product labeling, assessment and practical management of associated impacts.
  • Knowledge of global/regional regulations and guidelines pertaining to advertising and promotion materials and activities and demonstrated ability to decipher and understand implications of labeling changes on pending and approved products across regions.
  • The candidate must demonstrate a high level of understanding of labeling and promotion compliance.
  • Demonstrated ability to understand how updating one section of a labeling may impact promotional materials.
  • Proven ability to negotiate, influence and problem solve across a highly matrixed team.
  • Must be effective in managing workload and resolving conflicts.

If you are having difficulty in applying or if you have any questions, please contact Nicholas Walker at (+1) 646-367-2908 or n.walker@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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