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Senior Corporate Counsel
Refer job# LGPO137350
 
Senior Corporate Counsel Reporting to the General Counsel, the candidate will serve as the primary legal advisor to the Commercial, Medical Affairs and Compliance departments, including but not limited to providing advice on matters related to sales, marketing and promotional activities, medical education and medical affairs activities, distribution and managed markets activities, patient access programs, and other applications of commercial law in the biotech/pharmaceutical industry. Provide advice, guidance and counsel to the Commercial leadership team and U.S. Healthcare Compliance Officer on sales and marketing strategies, programs, policies, practices and initiatives in compliance with all healthcare laws, guidance documents or opinions, and industry codes (FDCA, Food and Drug CFRs, FDA guidance Documents, Fraud and Abuse laws, Anti-kickback Statute, federal and state transparency laws, OIG Advisory Opinions, etc.). Serve as the legal representative on the Promotional Review Committee and the Medical Review Committee to provide legal feedback and direction on materials submitted for review. Counsel and train field force as needed on Commercial advertising and promotional matters as well as medical affairs matters (e.g., KOL interactions, publications, advisory boards, medical education and investigator initiated grants, etc.). Review and provide legal guidance on direction to the field related to interactions with healthcare professionals, patients, or others in a position to influence healthcare decisions (e.g., payers, advocacy groups, distributors, etc.) to ensure compliance with applicable laws and regulations. Support and advise the U.S. Healthcare Compliance Officer on the design and execution of a robust healthcare compliance program, including compliance policies and procedures, fair market value methodologies and risk assessments, as well as support any healthcare compliance investigations in collaboration with outside counsel. Define risks and clearly communicate and explain those risks to appropriate internal decision-makers for discussion and resolution. Interact with various internal clients and functional groups to effectively address legal and business questions and provide guidance as well as practical solutions. Support administrative law activities as needed, such as review of government agency actions or requests for agency interpretation of regulatory enforcement issues. Draft, review, revise and negotiate a variety of agreements for the Company and advise on interpretation of existing agreements. Follow department processes to maintain transparency of legal review/negotiation of contracts for internal clients and track status of current contracts. Handle a variety of projects on an as needed basis under direction of the General Counsel. J.D., Graduation from an accredited law school and admission to a U.S. state bar and active license to practice law required. 10+ years of experience with a law firm that has a nationally recognized FDA/life sciences practice and/or equivalent experience as a member of a biotechnology or pharmaceutical company s legal department required. Experience: as a commercial lawyer providing legal advice and support for FDA-approved marketed products or equivalent required; at a pharmaceutical or biotechnology company strongly preferred. In house experience providing risk assessments and legal counsel regarding fraud and abuse questions, marketing and promotion of FDA approved products, communication of scientific knowledge to healthcare professionals and managed care customers, and healthcare compliance required. Excellent: verbal and written communication skills, must be an effective communicator with strong interpersonal skills; organizational (detail oriented) and problem-solving skills required. Strong computer skills (e.g., Microsoft Office Suite (Word, Exel, PowerPoint, etc.), Workshare, experience with document management systems, Veeva, DocuSign, Internet required.
 
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