Director, Reg Aff-Advertising & Promotion - Elite Resource Solutions LLC

Position Description

An established pharmaceutical company with products on the market is building an Advertising & Promotion function and we are looking for the leader.

Requirements:

•Advanced degree in a scientific or biopharmaceutical discipline; M.D., Ph.D. or PharmD. highly desirable.
•Minimum of ten years experience in the pharmaceutical industry and/or a regulatory authority with at least five years of direct managerial experience, and promotion, review and advertising experience.
•Thorough knowledge of: (1) FDA structure and regulatory requirements including comprehensive knowledge of CFR 21 with specific knowledge of promotion and advertising regulations; (2) Drug development across all therapeutic areas and stages of development including clinical and post-marketing; (3) familiarity with company’s investigational and marketed drug portfolio; and (4) Managerial related activities.
•Exceptional oral and written communication and problem solving skills.
•Excellent interpersonal and management skills.

Duties and Responsibilities:

•Represent DRA on the MLR Counsel and provide DRA strategic input and DRA managerial oversight of the MLR teams and process.
•Oversee DRA promotion review therapeutic teams with direct managerial responsibility for therapeutic area managers, Associate Directors, Senior Associate Directors and indirect managerial responsibility for product DRA personnel assigned to MLR teams. Responsible for development of therapeutic area personnel. Responsible for MLR resource allocation and resource planning.
•Review and revise DRA best practices, working instructions, SOPs for promotion and advertising. Establish and maintain relationships with external consultants and organizations.
•Provide oversight and guidance to DRA development teams regarding regulatory and legal requirements regarding scientific exchange for products in development. Serve as DRA interface with pipeline marketing.
•Develop and maintain a special training program for DR Astaf on products teams to ensure quality and consistency of regulatory inputs on review of promotional materials for marketing products.
•Serve as DRA member of interdepartmental management committee providing consultation to product teams for review of promotional materials and performing quality assurance auditing of this function.
•Represent DRA at monthly Sales Training program established for new sales representatives.

How to Apply

Application Instructions / Send a Resume