Counsel – Life Sciences Group Lowenstein Sandler’s Life Sciences Group is seeking a 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 for our Roseland, NJ or New York City office. Responsibilities include: 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; 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. Required experience includes 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. Experience as in-house counsel in the life sciences industry is preferred. Flexible work arrangements can be considered. Lowenstein Sandler LLP is an equal opportunity employer. Qualified minorities and/or women are encouraged to apply.
Posted
Updated
Closed
Position
Counsel
Practice Areas
FDA
Specialties
Compliance/Regulatory, Pharmaceuticals, Medical Devices