Healthcare Associate FDA & Life Sciences - CBOHN

Join one of the largest and most established national healthcare and life sciences teams in the country. This AmLaw 100 team embraces diverse perspectives, impeccable service and innovative delivery of business-minded healthcare solutions. We believe that one-on-one mentorship, training and collaboration maximize professional growth and performance. As part of a leading law firm, your healthcare expertise will contribute to a robust foundation and expanding services in life sciences regulatory work and other key clients across the health care industry.

Our healthcare and life sciences group and individual lawyers from across the country have been ranked by Chambers USA, Best Lawyers in America, Legal Elite and Super Lawyers as among the top legal providers in the nation. We are regularly sought out for our opinions and insights on healthcare and life sciences issues by industry journals and major news organizations ranging from The Daily Law Bulletin and American Health Lawyers, to Medical Laboratory Observer, MSNBC and HFM (a publication of the Healthcare Financial Management Association).

Our clients recognize the value of our depth in regulatory, litigation and transactional matters, and come to us from all critical sectors of the healthcare and life sciences industry to advise private equity funds, academic medical centers, pharmaceutical (prescription and OTC) and device companies, dietary supplement manufacturers, cosmetics, contract research organizations (CROs), cannabis multistate operators, imaging facilities, pre-clinical and clinical laboratories, site management organizations (SMOs), clinical trial networks, physician-hospital organizations (PHOs), pharmacies (retail, nuclear, 503(A) and 503(B)) and specialty medical clinics, as well as related distributors, suppliers, third-party logistics providers, and trade associations. We also represent venture capital firms, commercial banks, specialty lenders, investment bankers and individual investors in healthcare-related transactions.

• Successful candidates will have 3 to 5 years of FDA regulatory compliance experience, including preclinical through commercial product development, product approvals, labeling, inspections, manufacturing, recalls, 483 responses, adverse event management, contract drug and device manufacturing, quality agreements, life science diligence of acquisitions, experience with DSHEA, Food Drug and Cosmetics Act, and Federal Trade Commission Act, advertising and promotional practices for devices, drugs, dietary supplements, biologics, and cosmetics.
• Additional experience in state Boards of Pharmacy regulations and licensure, FDA market denial orders, credit agreements, IPOs in life sciences, cannabis licensure and regulation, telemedicine based drug delivery, and experience advising in litigation adjacent roles in life sciences a plus.
• We are specifically seeking candidates with experience servicing clients in the life sciences industry and understand the clients in the space through prior work.
• Candidates with experience in the foregoing with other complimentary areas of experience should also apply.
• Prior employment in a sophisticated law firm environment, healthcare experience, employment at FDA or life sciences company, and life sciences coursework in particular is favored.
• Excellent academic credentials and solid writing skills are required.