Exelixis
Responsible for primary regulatory review of promotional materials and scientific exchange communications. Ensures compliance with FDA regulations for prescription drug advertising and promotions. Provides regulatory guidance for the development, review, approval, and implementation of promotional materials. Serves as a decision-making member of the Review of Advertising, Marketing, and Promotions (RAMP) committee and/or Medical Review committee (MRC). Manages the development of relevant correspondence with health authorities and interpretation of health authority comments. Reviews and approves clinical development communications and materials.