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Neuromuscular Franchise Counsel
Refer job# LGIZ148932
 
Neuromuscular Franchise Counsel The candidate will be key member of our legal and compliance team who is responsible for providing this cross-functional franchise with legal, regulatory and healthcare compliance counsel and handling a variety of business transactions and contracting. This position will act as counsel for all neuromuscular products and will provide substantive advice to cross-functional departments including Commercial, Medical Affairs, and Regulatory Affairs and will support research and development activities in the US. Provide counsel concerning a broad range of legal, regulatory and compliance issues, including, among other things, application and interpretation of FDA regulations, the False Claims Act, Anti-Kickback Statute and competition law in connection with product labeling, promotional and non-promotional activities, marketing strategies, sales compensation, government reimbursement, and interactions with healthcare professionals. Reports to Head of Global Compliance. Provides strategic, operational and tactical legal and business insight on the commercial launch of product candidates in the US. From a legal and regulatory perspective, review and advise on programs, initiatives, contracts, policies and training related to sales, marketing, reimbursement, market access, case management, non-promotional education and scientific exchange. From a legal and regulatory perspective, review and advise on promotional materials, sales training materials, federal and state government price reports, product and disease-related communications and health economics materials; serve as a member of Materials Review Committee, along with medical and regulatory colleagues. From a legal and regulatory perspective, review and advise on interactions with patients, healthcare professionals, institutions, payors, regulatory agencies and government reimbursement programs. Serve as subject matter expert in the areas of US healthcare law and all applicable pharmaceutical marketing, drug pricing and reimbursement, anti-kickback, privacy, fraud and abuse, anti-bribery, Sunshine Act and product liability statutes and regulations. Identify training needs within the organization and develop and present training sessions on relevant laws and legal/business issues. Stay abreast of and communicate to the organization all significant pending and actual decisions, legislation and regulatory rulings that may affect the company in the area of commercial healthcare law. Closely coordinate risk assessment, investigation, training and update activities with Compliance personnel. Other duties as assigned.

The candidate should have J.D. from a law school accredited by the American Bar Association (ABA). Should be admitted to practice law in one or more states. Must have 7 years of biopharmaceutical industry experience, with extensive experience within a commercial stage pharmaceutical or biotech company, or law firm equivalent. Large law firm experience helpful. Experience with launching new products and/or new indications is essential. Must have expertise in the areas of corporate commercial healthcare and FDA regulatory law and regulation, including with respect to FDA labeling and promotional matters, healthcare fraud and abuse laws, pricing and reimbursement issues, US transparency laws and regulations, privacy laws, anti-bribery laws, and other laws and regulations related to the development and commercialization of pharmaceutical products. should have strong interpersonal and oral and written communication skills. Should be able to innovate, analyze and solve problems with minimal supervisory input, anticipating and identifying legal and other business risks and making recommendations to management, as appropriate. Solid understanding of business goals and legal and regulatory landscape is required. Must have high degree of personal, professional and corporate ethics, integrity and responsibility. Should have knowledge of and proficiency with laws and regulations applicable to global pharmaceutical companies, including among other things, the US Foreign Corrupt Practices Act, US fraud and abuse and false claims laws and PhRMA Code on Interactions with Healthcare Professionals. Must consistently shows initiative, and willing and able to take high levels of responsibility for complex initiatives. Demonstrated organizational skills are required.
 
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This particular job is currently not active. However, since our clients regularly share with us similar and other job openings, we strongly recommend that you submit your resume. We shall review your resume and get in touch with you as soon as a suitable vacancy comes up to further discuss your interest in exploring the opportunity. Assisting you is our highest priority.

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