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ProfileSr Corporate Counsel The candidate will provide legal support for one or more company products within the specialty care business unit of thecompany, focusing on rare disease and oncology. Serve as the legal contact to internal groups including commercial, sales, medical affairs, regulatory, and compliance, for the designated product(s) and the Global Business Unit focusing both on global and US issues. Ensure client operations comply with applicable laws and company policies, including Anti-kickback Statute and other US healthcare compliance laws and regulations, antitrust, and FDA requirements. Identify and analyze legal risks and proposal of appropriate actions to secure compliance with relevant rules, regulations, and policies, including coordinating and assisting in securing legal counsel from other company attorney’s globally in support of the global business strategy. Ensure that interactions with health care professionals and patients comply with applicable legal requirements and company policies. Interact with and advise senior business leaders concerning legal issues that have a direct effect on the success of the company and support of compliant strategy execution. Draft, negotiate, review and interpret agreements associated with the business, including agreements with health care professionals, vendors, licensors, consultants and speakers, and advertising, sponsorship, and other agreements supporting the business. Analyze product promotional materials and initiatives, advisory board proposals, speaker programs, and medical education initiatives for FCPA, fraud and abuse, FDA, and other regulatory compliance. Advise on brand/GBU strategic planning and business operation plans. Advise on FDA regulatory submissions, label negotiations, publication support and medical affairs activities including sitting as member of the Medical Affairs review committee. Review and advise on media relations materials including press releases, standby statements, Q & A documents, web sites and other company communications. Ensure that clients are kept abreast of all relevant legal developments in their areas of business. Counsel and collaborate with the Compliance department on policy development, training, and other relevant activities. Coordinate the legal aspects of client projects. Contribute to the achievement of clients’ business objectives. Act as Legal Department representative on cross-functional teams, as assigned. Coordinate with and support other members of the Legal Group, including coordination of global legal support relating to the company business unit. J.D. from an accredited law school and good standing in the state bar required. 5+ years of post-J.D. experience, preferably including both in a law firm and in-house, in the pharmaceutical, biotechnology, or medical device industry required. Substantive working knowledge of US Federal and state laws and regulations relating to the pharmaceutical industry, including without limitation the US Federal healthcare program requirements under the Food, Drug and Cosmetic Act (“FDCA”), False Claims Act, the Anti-Kickback Statute, and the Transparency Provisions of the Patient Protection and Affordable Care Act (the “Sunshine Act”) required. Experience working with pharmaceutical, biotechnology, or medical device industry marketing (advertising, promotion, labeling) and sales issues, including FDA promotion, anti-kickback, and fraud and abuse matters required. Knowledge: of FDA drug and medical device requirements and submission processes; of FDA promotional, advertising, and labeling requirements and processes for drugs required. Strong verbal and written communication skills required. Experience: participating in promotional review board; working in a matrix, international environment preferred. Prior experience as a member of an in-house legal department at a biotechnology or pharmaceuticals company preferred. Demonstrated excellence in (i) understanding and digesting complex scenarios in order to identify and evaluate relevant issues and risks, (ii) propose solutions that take into consideration the relevant business objectives and (iii) communicate those issues, risks, and solutions clearly and concisely to lawyers and non-lawyers alike required.
Job ID: R259