Associate Director, Advertising and Promotion Regulatory Affairs - Gilead Sciences : Job Details

* Review of promotional, corporate, and other non-promotional materials to assess for compliance with the applicable regulations, guidance documents, and internal policies/best practices.* Represent the commercial regulatory perspective at and chairing the promotional review committee (PRC) which includes cross functional partners from Marketing, Medical Affairs, and Business Conduct (US Legal).* Serve as a liaison to the FDA's Advertising and Promotional Labeling Branch for respective product(s) and will help ensure materials are submitted to FDA in a timely manner.* Ability to understand and evaluate all perspectives and provide experienced professional commercial regulatory guidance.* Characterization of the regulatory promotional perspective and reason at regulatory project team meetings, labeling meetings, brand team meetings and, as needed, providing training to cross-functional colleagues including members of the PRC.* Responsible for reviewing and interpreting enforcement letters, keeping current with industry changes relating to advertising and promotion, interpreting new Guidances to Industry, and, as applicable, evaluating related internal policies/best practices and processes.Assume a leadership role in advising cross-functional stakeholders on the commercial regulatory impact of new campaign concepts and product labeling and may also be desired to provide strategic regulatory guidance on corporate communications and appropriate pre-approval communications with managerial oversight, as appropriate.Doctorate and 2+ years of relevant industry experience ORMaster's and 8+ years of relevant industry experience ORBachelor's and 10+ years of relevant industry experience ORAssociate and 12+ years of relevant industry experience ORHigh School Diploma/GED and 14+ years of relevant industry experience* Regulatory review of promotional materials for prescription drug and/or biologic products* Oncology, immunology, and/or other relevant therapeutic area experience is desirable.* An advanced degree is also desirable.* Experience working with FDA's Office of Prescription Drug Promotion or Advertising and Promotional Labeling Branch is preferred.* Excellent verbal and written communication skills and interpersonal skills are desired.* Must be capable of developing and implementing commercial regulatory strategy and managing complex negotiations with internal and external stakeholders.* Assumes a leadership role in updating and advising Company stakeholders on changes in regulations, policies, and enforcement which may impact the Company's promotional activities.* The position will be recognized as a knowledgeable resource for commercial regulatory advice on promotional, corporate and other non-promotional initiatives in other departments.Everyone at Kite is grounded by one common goal – curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work.#J-18808-Ljbffr