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ProfileDirector Senior Legal Counsel Regulatory and Development Law The candidate will be responsible for providing food and drug law-related legal support on regulatory issues relating the approval, manufacturing and marketing of firm's products, including providing legal input on promotional materials relating to an assigned portfolio of medical devices. Will focus primarily on firm's ophthalmic surgical portfolio, but may also present opportunities to provide input on matters relating to firm's consumer-oriented contact lens and lens care business. Serve as a subject matter expert on food and drug law matters relating to regulatory approval, manufacturing, safety reporting, and promotional requirements. As assigned, serve as the primary point of contact for advertising-related issues for multiple high-profile firm products or initiatives, including: reviewing and approving promotional materials and product labeling for specific firm products; and coordinating legal support for advertising challenges with the potential for significant business impact, including management and oversight of outside counsel. Provide input on clinical studies intended to support proposed product and/or indication launches. Identify and interact with counterparts in other Novartis affiliates to level-set and ensure consistency of approach. Manage outside counsel to ensure that firm receives timely, efficient and effective legal advice and representation; and that legal fees and expenses are reasonable for the services provided.
Qualification and Experience
The candidate should have Law degree and Bar admission, or license to practice law in a relevant jurisdiction. Should have 6+ years of relevant prior legal experience. Prior scientific or technical training is a plus. English fluency is required. Should have prior experience advising pharmaceutical, medical device, or consumer product companies one or more of the following areas is also preferred: EU CE Mark and/or Medical Device Regulation standards; anti-bribery or anti-kickback considerations (e.g., FCPA or FCA); implementation of global compliance codes (e.g., the AdvaMed and EucoMed codes); basic transactional or litigation matters, particularly competitive disputes (Lanham Act litigation, NAD challenges); drafting and negotiation of clinical trial transactional documents (e.g., clinical research agreements, CRO vendor agreements, specialized consulting agreements); and advising on medical device reimbursement matters. Significant prior expertise advising medical device manufacturers on regulatory and quality issues in a law firm or in-house setting is essential. Comprehensive knowledge of FDA and FTC standards relating to the approval, manufacturing, and promotion of medical devices is essential.
Job ID 207026BR