The candidate will handle cutting edge, high-profile pharmaceutical and medical device fraud and abuse matters from early-stage development/investigation through litigation and trial. Must have Juris Doctorate degree from a top tier institution with excellent academic credentials and references. Must have 2+ years of FDA litigation experience as an attorney with a focus on pharmaceutical, biotech and/or medical device matters. Experience in fraud and abuse matters related to manufacturing, utilization and pricing are a plus. Must have licensed to practice law in Washington, D.C. or be eligible to become licensed to practice in Washington, D.C.
The candidate should be a mid-level pharmaceutical regulatory associate with 3+years of experience and an emphasis on experience in fraud and abuse and pricing matters. Must have a J.D. degree from an ABA-approved law school and be an active member in good standing of the Bar. Knowledge of FDA drug regulation would be a plus.
Associate - Health (FDA)
Candidate should have 3-5 years' experience for the Washington, D.C. office. Experience working on matters relating to and arising out of FDA regulation of drugs, devices, biological products, health information technology and/or consumer products is required. Must have experience in some or all of the following areas: clinical research and clinical trial oversight, marketing applications (e.g., NDAs, INDs, IDEs, 510(k)s and PMAs), and prescription drug advertising and product promotional review. Should have excellent analytical skills, writing skills, and academic records.
Associate - Health (FDA)
The candidate must have 5-7 years of experience. Should have extensive experience analyzing a wide range of regulatory and compliance matters arising under the Federal Food, Drug, and Cosmetic Act. Must be familiar with issues such as current good manufacturing practice (cGMP) and Quality System requirements, development and commercialization agreements, Hatch-Waxman issues, citizen petitions and other administrative proceedings, regulatory due diligence for pharmaceutical and medical device transactions and prescription drug and medical device promotion. Should have excellent analytical skills, writing skills, and academic records.
Life Sciences/FDA Regulatory Associate
The candidate should have 3 years of experience. This role will draft and negotiate agreements, counsel clients regarding fraud and abuse issues associated with pharmaceutical and medical device development and marketing activities and conduct health regulatory due diligence on transactional matters in the life sciences industry.