Associate Director, Advertising and Promotion Regulatory Affairs
Gilead Sciences, Inc.Santa Monica, CA, United Statesjob_description.job_card.30_days_ago
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job_description.job_card.job_descriptionReview 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.
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Regulatory Promotion • Santa Monica, CA, United States
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