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Epstein Becker Green

Associate Attorney, Health Care – Life Sciences

Epstein Becker Green

. Join Epstein Becker Green’s Health Care and Life Sciences Practice in the Washington, D.C.

Posted 11/3/2026full-timeUnited StatesJuniorMid-Level💰 $210,000 - $260,000 per yearWebsite

Core Competencies

Role fit
Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in FDA regulation and product pathways, including Pre-Sub, Pre-IND, 510(k), De Novo, and 505(b)(2). Proficient in contract drafting, negotiation, and compliance with health law, including Anti-Kickback Statute and fraud and abuse issues.

Highest-signal resume keywords
FDA Regulation KnowledgeContract Drafting And NegotiationHealth Regulatory ComplianceRegulatory Pathway AnalysisState Licensure Compliance

ATS Keywords

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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills
Regulatory Status AnalysisPremarket And Lifecycle SupportLabeling And PromotionPost-Market ReportingFDA InspectionsForm 483sWarning LettersUntitled LettersClinical Trial AgreementsQuality Agreements
Soft Skills
CollaborationClient CommunicationAnalytical Thinking
Tools & Technologies
Client AlertsTraining MaterialsComment Letters
Certifications & Qualifications
Attorney Qualification
Industry Keywords
Health LawLife SciencesAnti-Kickback StatuteFraud And AbuseCMSOIGState Boards Of Pharmacy

About the role

Key responsibilities & impact
  • Join Epstein Becker Green’s Health Care and Life Sciences Practice in the Washington, D.C. office
  • Analyze and explain to clients whether and how FDA regulates products
  • Support private equity, strategic, and lender clients on life sciences transactions
  • Advise drug and device manufacturers on Anti-Kickback Statute, fraud and abuse, sponsored testing, patient support and assistance programs, expanded access, advertising and promotion, scientific exchange, and compliance program design and training
  • Assist with Pre-Sub and Pre-IND strategy, 510(k), De Novo, and 505(b)(2) pathway analysis
  • Advise on 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
  • Draft, revise, and negotiate clinical trial, contract manufacturing, quality, and distributor agreements
  • Track FDA, CMS, and OIG developments and produce client-specific analysis, client alerts, training and CLE materials, and comment letters
  • Collaborate with transactional, reimbursement and coverage, fraud and abuse, and privacy colleagues

Requirements

What you’ll need
  • Minimum of two years of relevant health law experience
  • Attorney qualified to work at the level of a junior associate
  • Experience in one or more preferred areas: regulatory status and pathway analysis; health regulatory due diligence; commercial compliance for drug and device manufacturers; premarket and lifecycle support; inspections and enforcement; state licensure compliance; contract negotiations; policy tracking and thought leadership
  • Knowledge of FDA regulation and product pathways, including Pre-Sub, Pre-IND, 510(k), De Novo, and 505(b)(2)
  • Knowledge of Anti-Kickback Statute and fraud and abuse issues
  • Experience with labeling and promotion, post-market reporting, recalls, FDA inspections, Form 483s, warning and untitled letters, DOJ or OIG inquiries
  • Knowledge of state licensure requirements and coordination with state boards of pharmacy
  • Contract drafting, revision, and negotiation, including clinical trial, contract manufacturing, quality, and distributor agreements
  • Ability to track FDA, CMS, and OIG developments and prepare client-specific analysis, alerts, training, CLE materials, and comment letters
  • Ability to collaborate with transactional, reimbursement and coverage, fraud and abuse, and privacy colleagues
  • Qualified applicants with criminal histories will be considered consistent with applicable fair chance laws

Benefits

Comp & perks
  • Generous employee benefits package
  • Discretionary bonus
  • Mentorship and training
  • Clear paths to expand skills and responsibilities
  • Cross-office collaboration
  • Modern knowledge tools
  • Opportunities to explore adjacent practices and industry issues
  • Flexible career opportunities