Salary
💰 $135,100 - $225,100 per year
About the role
- Provide strategic support to the review of Advertising and Promotion materials to meet US brand team objectives while ensuring regulatory compliance (OPDP, APLB) and Pfizer policies
- Ensure reviewed promotional materials are accurate, truthful and not misleading, presented in a fair and balanced manner, consistent with applicable product labeling, and well-substantiated by current and scientifically valid evidence
- Ensure materials adhere to applicable advertising and promotion standards and comply with all internal and external policies and procedures
- Work independently and recognize when issues need to be elevated to Senior Management
- Monitor and share with RC Members information on material regulatory developments and trends relevant to the RC, OPDP and APLB issues and specific promotional materials
- Provide guidance for team on overall benefit/risk assessments of promotional activities and strategies
- Effectively communicate regulatory issues and concerns to senior governance groups including Marketing, Legal and Medical
- Ensure business compliance and implementation of and adherence to Regulatory standards
- Conduct regulatory review of internal and external business communications
- Engage with Agency contacts (OPDP, APLB) and trade associations to improve the regulatory environment
Requirements
- BS/BA or equivalent
- Science degree/advanced degree is preferred
- 6+ years industry/applicable experience
- Allowances for experience may be made based on multiple factors, including relevant education, advanced degrees, fellowships, and overall experience
- Life sciences degree (preferred)
- Advanced degree in a relevant field (science, pharmacy, law) (preferred)
- Advertising & Promotion experience (preferred)
- 1+ years in relevant disease area(s) (preferred)
- Experience interacting with FDA including OPDP and APLB (preferred)
- This position requires permanent work authorization in the United States
- Live within commuting distance and work on-site an average of 2.5 days per week (hybrid)