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Associate Director, Corporate Council (Medical Legal Review)
MLR Counsel, Associate Director will report to the Vice President, General Counsel and work with the client’s Legal and Commercial teams and members of the promotional review committee, referred to as the Medical Legal Regulatory (MLR) Committee, to ensure completion of legal and healthcare compliance reviews of promotional, commercial, and medical submissions to the MLR Committee.
Responsibilities include managing and reviewing sales, marketing and commercial activities through the promotional and medical review process to ensure that Company programs, materials, and strategies are compliant with Company policies and legal requirements. Opportunities to expand by handling additional responsibilities on the Legal team are also available at the desire of MLR Counsel.
• Advising commercial business units with the review and assessment of advertising and promotional materials through senior participation in the MLR Review Committee.
• Providing healthcare compliance guidance for various therapeutic areas (including dermatology, biologics neuroscience, oncology, and ophthalmology);
• Advising company executives on healthcare compliance policies, procedures, and laws;
• Collaborating with Medical and Regulatory Affairs to conduct a detailed review and evaluation of the adequacy of promotional claims and tactics to ensure consistency with FDA approved labeling.
• Juris Doctorate degree required.
• At least 3 years of direct experience conducting legal reviews of advertising and promotional content and practical experience in the interpretation of industry regulations and guidance documents.
• Demonstrated knowledge of regulations and regulatory guidance specific to advertising and promotion of pharmaceutical / biologic products.
• Must have knowledge and experience to act upon compliance issues related to sales, marketing and medical affairs activities, government programs, federal healthcare program reporting, continuing medical education programs, and overall business ethics programs.
• Knowledge of laws (FD&CA, Anti-kickback Statute, False Claims Act, Foreign Corrupt Practices Act, PDMA, FDAAA, HIPAA, state laws), regulations, industry guidance and best practices regarding compliant sales, marketing, medical affairs activities, primarily through experience in the pharmaceutical industry and/or with pharmaceutical manufacturer activities.
• Experience in pharmaceutical industry and/or with pharmaceutical manufacturer activities preferred.