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Our client, a clinical-stage bio pharmaceutical company, is looking to hire an attorney with 5+ years of experience to report to the General Counsel. The position is responsible for handling a variety of healthcare-related legal, regulatory and compliance issues governing pharmaceutical products with a primary focus on laws and regulations relating to advertising and promotion, fraud and abuse and anti-trust and for providing contractual and commercial support to the US organization as it prepares for its BLA submission and potential product launch.
Provide legal and business advice to Regulatory Affairs, Medical Affairs and Commercial departments concerning a broad range of legal, regulatory and compliance issues, including Food, Drug and Cosmetic Act, False Claims Act, Anti-Kickback Statute, OIG guidance, the PhRMA Code, the Sunshine Act, Foreign Corrupt Practices Act and competition law
Analyze product labeling, promotional materials, marketing strategies, brand plans, salesforce initiatives, supply chain issues and business plans, advisory board proposals, speaker programs, medical education initiatives and external company communications and social media for legal risks and propose appropriate actions to secure compliance with relevant rules, regulations and policies
Prepare, review and negotiate commercial agreements as well as, 3rd party vendor, service, pharmacy, consulting and other corporate agreements
Counsel and support business and technology teams by providing advice on legal, contractual and privacy requirements related to websites, mobile applications, and similar initiatives
Regularly update clients on relevant legal developments in their areas of business.
Counsel and collaborate with the Compliance Department on policy interpretation, training, and other relevant activities
Provide legal advice and assistance for the development of policies and training, and conduct training
Support General Counsel on corporate matters, projects and transactions
D. required plus an active license to practice law in any state
5+ years of corporate counsel experience in the life sciences industry required
Expertise with respect to FDA laws and regulations, the Anti-Kickback Statue, False Claims Act, government pricing, market access, and privacy laws
Strong contract drafting and negotiation skills
Ability to travel domestically and internationally as needed
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