The Everest Group


*A division of The Everest Search Group, Inc., Los
  Angeles, CA
*The Everest Search Group Inc., Lake Tahoe, NV

Ranked Top 200 of America's Best Executive Search Firms in 2017 by Forbes

Senior Manager Promotional Regulatory


Company
Our client is a top 10 global branded & generic pharmaceutical company with over $20Billion in revenue, a portfolio of pharmaceutical products and biologics from a wide range of therapeutic areas including, Women's Health, GI, Cardiovascular, Pain, Ophthalmology, Respiratory, CNS, and Oncology.  

Location: PA

Responsibilities
Primarily responsible for the regulatory review of advertising and promotional materials for assigned products within the pharmaceuticals portfolio. The portfolio includes products in the respiratory, CNS, oncology, pain, and women’s health therapeutic areas.
• Review advertising, promotional and other related materials for assigned products to ensure compliance with applicable FDA laws, regulations, and guidance. 
• Provide regulatory expertise and guidance within a collaborative cross-functional team that includes Legal, Medical Affairs, and Marketing. 
• Serve as primary contact with FDA Office of Prescription Drug Promotion (OPDP) for assigned products.
• Review and approve Form FDA-2253 submissions to OPDP.
• Work cross-functionally to develop and implement revised/new labeling and supporting documentation for assigned products.
• Maintain a continued awareness and understanding of FDA regulations, guidance documents, and enforcement actions with regards to advertising and promotion of pharmaceutical products.
• Perform other duties as assigned.

Qualifications
• BA/BS Degree, preferably in a health/life sciences or related field.
• 3-5 years experience in the review of advertising and promotional materials within the pharmaceutical industry.
• Strong knowledge of FDA regulations and their interpretation relevant to prescription drug advertising, promotion, and labeling.
• Working knowledge of the drug/biologic development process, including labeling development process.
• Demonstrated ability to work independently and collaboratively in a fast-paced environment.