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Carrot Peelers, Sales, Personality and Your Job Search
In-House
Attorney
Litigation - General (consumer)
Min 7 yrs required
Director, Regulatory Affairs Advertising & Promotion The candidate will be responsible for providing strategic guidance on the development and implementation of a creative and compliant advertising and promotion program for Blueprint’s pre-launch and commercial oncology and rare-disease portfolio. She/he will work with limited supervision to review and provide strategic advice on advertising and promotion materials, in accordance with the requirements of the US Food and Drug Administration (FDA), company policy, and business goals and objectives. Will also ensure effective communication and constructive working relationships with regulatory authorities and internal/external collaborators. Serves as the primary regulatory advertising and promotion reviewer on cross-functional Promotional Review Boards (PRB) for the successful launch of Blueprint’s commercial programs, and on Medical Review Boards (MRB) for the compliant scientific exchange of information of Blueprint’s investigational programs. Acts as primary contact with FDA’s Office of Prescription Drug Promotion (OPDP), including responding to agency inquiries and managing company requests for advisory review. Develops solutions to complex US promotional issues by utilizing scientific and regulatory knowledge to support business objectives and initiatives while effectively managing business risks. Identifies and provides guidance on development and improvement of policies, processes, and standards for promotional materials and related activities. Works closely with Regulatory counterparts to ensure that global development strategies result in commercially viable labeling, in support of desired promotional claims. Participates in training of Blueprint personnel on advertising and promotional materials, as required. Provides oversight to relevant external vendors and consultants, particularly as it relates to ex-US advertising and promotional activities. Monitors and keeps organization up-to-date on US regulatory promotional environment (e.g., the issuance of new FDA regulations/guidance, relevant FDA enforcement action and general awareness of industry practices, including those of competitors).
Qualification and Experience
A BA/BS Degree required. Advanced degree preferred (MS, PhD, PharmD, or JD). Should have 10 years of pharmaceutical industry experience, with at least 7 years of experience focused on the regulatory review of advertising and promotion materials for prescription drug products. Experience with launching new products and/or new indications a must; with experience in oncology and/or rare diseases a plus. Direct experience interacting with OPDP required. Experience with ex-US promotional activities a plus. Experience in managing multiple global programs required. Experience working on an accelerated approval product a plus. Should have strong interpersonal and oral and written communication skills. Must be able to innovate, analyze, and solve problems with minimal supervisory input, anticipating and identifying regulatory risks and making recommendations to management, as appropriate. Should have solid understanding of business goals and common marketing concepts/tools, including the internet and social media.
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