Healthcare & Life Sciences Legal Careers

Advising on HIPAA compliance, Stark Law, Anti-Kickback Statute, fraud and abuse laws, and federal and state healthcare regulations. You'll support compliance with Medicare, Medicaid, TRICARE, and 340B Drug Pricing Program requirements, conduct regulatory risk assessments, respond to government investigations and audits, and advise on healthcare provider agreements and payor contracts. Your counsel helps hospitals, health systems, physician practices, and healthcare organizations navigate complex regulatory frameworks while maintaining ethical standards and minimizing compliance risk across operations.

Providing strategic guidance on FDA regulatory submissions, product approval pathways, post-marketing compliance, and adverse event reporting for pharmaceutical companies, medical device manufacturers, and biotechnology firms. You'll advise on regulatory strategy for drug and device development, support inspections and enforcement actions, ensure compliance with Good Clinical Practice and Good Manufacturing Practice standards, and navigate complex federal regulations governing product development and commercialization. Your expertise accelerates the path from concept to market while ensuring regulatory compliance.

Negotiating clinical trial agreements with sponsors, principal investigators, and research institutions while ensuring compliance with IRB requirements and federal regulations. You'll draft informed consent forms, manage multi-site clinical research contracts, advise on data ownership and publication rights, coordinate collaborations between pharmaceutical companies and academic medical centers, and protect intellectual property and confidential information throughout the research process. Your work supports Phase I-IV clinical trials and investigator-initiated research while balancing legal precision with operational efficiency.

Drafting and negotiating manufacturing services agreements, commercial supply agreements, and CDMO contracts for pharmaceutical and biotechnology companies. You'll advise on cGMP manufacturing requirements, establish quality agreements and specifications, manage raw materials sourcing and packaging arrangements, negotiate contract manufacturing and toll manufacturing deals, and address warehousing and logistics considerations. Your counsel ensures reliable supply chains while protecting intellectual property, managing performance metrics, and maintaining regulatory compliance across complex manufacturing relationships.

Advising on government pricing programs including Medicare, Medicaid, VA Federal Supply Schedule, and 340B Drug Pricing Program compliance. You'll negotiate commercial payer contracts and PBM agreements, develop value-based contracting arrangements, support drug price reporting obligations including AMP and Best Price calculations, advise on Inflation Reduction Act compliance and CMS negotiations, and structure patient access programs and affordability initiatives. Your strategic guidance navigates the complex pharmaceutical supply chain while optimizing market access and ensuring compliance with pricing regulations across federal and commercial channels.

Negotiating physician employment agreements, healthcare provider service agreements, payor and managed care contracts, and health information technology platform agreements. You'll support M&A due diligence for healthcare and life sciences transactions, draft collaboration and licensing agreements, advise on telehealth and digital health legal frameworks, and handle commercial relationships across the healthcare ecosystem. Your work helps clients structure transactions and partnerships that advance innovation while managing regulatory and commercial risks.