Healthcare Associate – FDA & Life Sciences

Job Description

The Raleigh office of McGuireWoods seeks an Associate to join its Life Sciences Team in its Healthcare Department.

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, HFM (a publication of the Healthcare Financial Management Association), the Pink Sheet, Law 360, and the Wall Street Journal.

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 medical device companies, diagnostics, dietary supplement manufacturers, cosmetics, radiopharmaceuticals, excipient manufacturers, stem cell clinics, drug compounding pharmacies, contract research organizations (CROs), imaging facilities, research 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 and life sciences-related transactions.

McGuireWoods, one of the world’s leading law firms, has provided legal solutions to corporate, individual and nonprofit clients since 1834. Along with excellent benefits, McGuireWoods offers our attorneys a competitive salary with hours and merit bonus opportunities and billable hours credit for pro bono work. Continually establishing new initiatives and enhancing existing efforts, we focus on meaningful support for our lawyers in their careers. Our Applicant Disclosures describe your rights. Our Privacy Statement describes how we will process and safeguard your personal data.

Job Requirements

• Qualified candidates will have 3-5 of relevant experience in a top 100 law firm setting.
• Successful candidates will have 3 to 5 years of experience in life sciences law, including regulatory advisory work, contract review, and transactional work including licenses, M&A, IPOs, Private Equity, Venture Capital, Debt Finance and other banking investment deals.
• FDA and other regulatory compliance experience in drugs/biologics/medical devices and other products regulated by FDA, such as: preclinical through commercial product development, INDs and IDEs, NDAs/BLAs/DeNovo/510(k)s and other product clearances and approvals; LDTs/IVDs - CLIA and state requirements; product labeling, inspections, manufacturing, recalls, 483 responses, untitled and warning letters, adverse event management; contract drug and device manufacturing, quality agreements; experience with DSHEA, PDMA, DCSCA; advertising and promotional review for devices, drugs, dietary supplements, biologics, and cosmetics based on FDA, FTC and other applicable laws; scientific exchange; contracting with CMOs, CROs, CDMOs, laboratory and other life sciences vendors and partners.
• Experience in OIG, CMS, and DOJ matters impacting the life sciences industry, such as: matters pertaining to public and private reimbursement; drug pricing, discounts rebates and other anti-kickback safe harbors and state law equivalents; the Medicaid Drug Rebate Program, CMS price reporting, HRSA / 340B program, and the Inflation Reduction Act’s drug pricing provisions; state & federal “sunshine” and transparency laws, EKRA, Anti-Kickback, False Claims Act and other laws/regulations that apply to manufacturer/provider/supplier arrangements, payor/wholesaler/distributor/GPO and other arrangements; compliance program design, implementation, and policies in alignment with OIG/DOJ expectations; PhRMA Code and AdvaMed compliance.
• Additional experience in state Boards of Pharmacy regulations and licensure, DEA permitting, FDA establishment licensing and other registrations, debarment and exclusion issues (OIG, SAM and FDA) is desired.
• Additional experience telemedicine and experience advising in litigation adjacent roles in life sciences is a plus.
• We are specifically seeking candidates with experience servicing clients in the life sciences industry and who understand the clients in the space through prior work and practical experience.
• Candidates with experience in the foregoing with other complimentary areas of experience should also apply.
• Prior employment in a sophisticated law firm environment, in-house healthcare experience, employment at FDA, CMS, DOJ, or other relevant agencies or employment in-house at a life sciences company, and life sciences coursework in particular is favored.
• Candidates should possess strong interpersonal skills and the ability to interact with client, business, and legal teams.
• Must have a strong academic record, excellent writing, and oral communication skills.
• North Carolina Bar is required.
• Please submit cover letter, resume, law school transcript, and writing sample.
  
  

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