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Years of Experience
Date Last Verified
ProfileCounsel, Advertising and Promotion The candidate will provide day-to-day advice regarding promotional materials, commercial communications, and related activities for company and its products, including prescription and OTC pharmaceutical products as well as consumer health products. Will work cross functionally with Marketing, Communications, Medical Affairs, Regulatory, and Compliance to provide advice on company's sales, marketing, and communications activities. Participate in committee meetings to review and approve promotional materials and commercial communications in support of corporate goals and in compliance with applicable laws, regulations, and policies. Work with other functions to provide baseline and ongoing training to Marketing, Communications, and other functions on laws, regulations, and policies related to promotional materials and commercial communications. Work closely with other functions to evaluate and advise on promotional applicability of information in labels for pipeline and marketed products. Assist in counseling on regulatory matters as they relate to, or are implicated by, such materials, communications, and activities. Monitor the external environment and advise product teams on policy and regulatory developments related to promotional materials, commercial communications, and related activities.
Qualification and Experience
The candidate should have a J.D. degree and 5+ years of FDA regulatory law experience working in a law firm, government agency or pharmaceutical company. Related experience/education may also be considered. Should also have 3+ years of experience in reviewing pharmaceutical promotional materials and interaction with the FDA's Office of Prescription Drug Promotion. Must be licensed as an attorney in one or more jurisdictions. Should have expert knowledge of laws, regulations, guidance and precedents related to pharmaceutical and consumer health marketing, with focus in the area of advertising and promotion. Familiarity with web-based communications (e.g., widgets, RSS-feeds, blogs) and portable digital technologies (e.g., iPad, smart-phones) is needed. Ability to assist in counseling on anti-kickback, fraud and abuse, and pricing matters in the US, and similar and related issues globally a plus. Proficiency in speaking, comprehending, reading and writing English is required.
Ref. #: 18000251
1000 Mylan Blvd.
Canonsburg, PA 15317