Associate Attorney, Health Care & Life Sciences
Epstein Becker & Green, P.C.•Washington, DC
•$210,000 - $260,000•Onsite
About The Position
Epstein Becker Green is seeking a junior associate attorney for its Health Care and Life Sciences Practice in the Washington, D.C. office. The role involves advising health care and life sciences clients on regulatory, compliance, transactional, and policy matters. The position offers work on client and firm initiatives, mentorship and training, cross-office collaboration, and opportunities to develop skills and responsibilities across related practices.
Requirements
- Minimum of two years of relevant health law experience.
Nice To Haves
- Experience in one or more of the following areas: FDA regulatory status and pathway analysis; health regulatory due diligence; commercial compliance for drug and device manufacturers; premarket and lifecycle support; FDA inspections and enforcement; state licensure compliance; life sciences contract negotiations; policy tracking and thought leadership.
Responsibilities
- Analyze and explain whether and how the FDA regulates products.
- Support private equity, strategic, and lender clients with health regulatory due diligence for life sciences transactions.
- Advise drug and device manufacturers on commercial compliance, including Anti-Kickback Statute and fraud and abuse issues; sponsored testing; patient support and assistance programs; expanded access; advertising and promotion; scientific exchange; and compliance program design and training.
- Assist with premarket and lifecycle matters, including Pre-Sub and Pre-IND strategy, 510(k), De Novo and 505(b)(2) pathway analysis, labeling and promotion, post-market reporting, and recalls.
- Support clients through FDA inspections, Form 483s, warning and untitled letters, remediation, and related DOJ or OIG inquiries.
- Advise life sciences companies on state licensure requirements and coordinate with state boards of pharmacy on applications, inspections, and ongoing compliance.
- Draft, revise, and negotiate life sciences contracts, including clinical trial, contract manufacturing, quality, and distributor agreements.
- Track FDA, CMS, and OIG developments and prepare client-specific analysis, client alerts, training and CLE materials, and comment letters.
- Collaborate with transactional, reimbursement and coverage, fraud and abuse, and privacy colleagues.
Benefits
- Generous employee benefits package
- Eligible for a discretionary bonus
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
No Education Listed
