Associate General Counsel – Neurology and Rare Disease U.S. (UCB, Inc. – Smyrna, GA); Multiple positions available. Provide day-to-day in-house legal support to the U.S. Rare Disease and Neurology organization and its U.S. portfolio and sit on the Rare Disease Leadership team at the Global Level. Provide and direct legal support of the cross-functional teams responsible for launch and commercialization of U.S. Rare Disease brands and activities. Work with global colleagues and provide support and legal direction for global initiatives. Oversee the strategic advice provided, counsel and manage direct report who provides strategic advice to UCB’s U.S. Rare Disease and Neurology business. Provide legal advice and guidance on anti-kickback and fraud & abuse considerations, antitrust, PDMA, privacy, HUB support services, REMs programs, as well as FDA regulatory matters, including promotions and advertising regulations. Prepare for new product launches in the rare disease space. Negotiate and draft complex contracts for the U.S. Rare Disease and Neurology business, including commercial, collaboration, and research agreements. Advise on key business initiatives including market research, real world evidence, and scientific congresses. Travel required up to 15% of working time (typically 2-3 international trips per year and approximately 3 domestic trips per year). Position based in Smyrna, GA; telecommuting permitted up to 60% of working time.
Requires a J.D. or LLM, (or foreign equivalent) and 8 years of experience in the job offered or in pharmaceutical or healthcare law. In lieu of a J.D. or LLM, (or foreign equivalent), will accept a PhD (or foreign equivalent) in Biochemistry, Pharmaceutical Science, or a related field. Must have 8 years of experience in each of the following: Working with or providing counsel to executive team members on complex pharmaceutical legal issues; Coaching and mentoring direct reports and/or peers; Working within the legal department or providing counsel to the pharmaceutical, medical device, or life sciences industry; Launching new drug products; Reviewing and adhering to FDA regulations; Working with or providing counsel on the Federal anti-kickback and other Federal pharmaceutical statutes (including Food Drug & Cosmetic Act, including amendments, FDA Guidance Documents and OIG Advisory Opinions); and Legal drafting, writing, negotiation, and document review. Must hold a license to practice law in the U.S. or abroad. Experience may be gained concurrently. Travel required up to 15% of working time (typically 2-3 international trips per year and approximately 3 domestic trips per year). Position based in Smyrna, GA; telecommuting permitted up to 60% of working time.
Apply with resume to HRAnswers@ucb.com. Reference Job ID: 5954074.
