Nine years in GSK Regulatory Affairs and 22 years as Independent Consultant on drug advertising and promotion issues for large pharma, start-up, device and consumer product companies. • Provide regulatory guidance on advertising and promotion materials to maximize commercialization while maintaining compliance with FDA/OPDP regulations • Evaluate clinical support for desired promotional claims; present risk assessment in light of regulatory and competitive environments • Guide Marketing on launch strategies, reprint policies and overall promotional approach• Coordinate responses to OPDP enforcement letters and initiate corrective action• Prepare formal competitive complaint letters to FDA/OPDP• Draft Standard Operating Procedures (SOPs) for internal approval of promotional material and sales training materials• Review marketing presentations for clarity, readability, consistency and grammar• Provide internal training for Regulatory, Medical and Marketing on advertising compliance• Educate legal defense team on advertising, labeling and marketing practices within the pharmaceutical industrySpecialties: Regulatory; Advertising and Promotion of Prescription Drugs