Healthcare Associate – FDA & Life Sciences

Join one of the largest and most established national healthcare teams in the country. This 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 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 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 industry to advise private equity funds, academic medical centers, pharmaceutical and device companies, dietary supplement manufacturers, cosmetics, contract research organizations, cannabis multistate operators, ambulatory surgery centers, assisted-living and long-term care facilities, dialysis centers, hospitals and hospital systems, hospices, imaging facilities, clinical laboratories, nursing homes, management service organizations (MSOs), physician-hospital organizations (PHOs), pharmacies and specialty medical clinics, as well as medical staff organizations and medical, healthcare and related 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+ years of FDA regulatory compliance, including product development, product approvals, labeling, inspections, manufacturing, recalls, 483 responses, adverse event management, contract drug 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 the Tobacco Control Act, State Board of Pharmacy regulations, FDA market denial orders, credit agreements, pharmaceutical IPOs, cannabis licensure, 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 science 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, FDA, or life sciences company, and life sciences course work in particular is favored.

• Excellent academic credentials and solid writing skills are required.

• Applicants should be admitted to practice in North Carolina.

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