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Organization TypeLaw Firm
Years of Experience
Date Last Verified
ProfileNew York City office of our client seeks senior attorney with 7+ years of experience in the life sciences industry advising pharmaceutical and biotech companies from clinical development through commercialization for prescription drugs, biologics and medical devices. The candidate will be advising clients on FDA regulatory and fraud and abuse compliance issues related to pre-approval product communications, interactions with payors/managed markets, advertising and promotion, interactions with healthcare professionals, and sample accountability. Will be serving on internal company committees including compliance and promotional review. Drafting compliance policies and procedures and conducting client training on the laws and regulations governing the sales and marketing of regulated products. Negotiating/drafting commercial agreements for various customer segments including specialty pharmacies, pharmacy benefit managers, group purchasing organizations, wholesalers, integrated delivery networks, distributors, third-party logistics providers and master service agreements for all commercial aspects of the business. Assisting clients in establishing global clinical development programs; negotiating and drafting the various agreements relevant to a clinical development program, including development and formulation; contract research organizations; clinical trial sites; laboratory services; manufacturing; packaging; drug storage and shipment; meeting logistics and other necessary vendor agreements. Assisting with healthcare compliance and clinical trial related investigations. Training and management of junior attorneys. Must have knowledge of FDA laws and regulations governing pre-clinical and clinical development, as well as familiarity with European Union requirements. Knowledge of federal and state transparency and aggregate spend laws is essential. Experience as in-house counsel in the life sciences industry is preferred.