Life Sciences Ethics & Compliance Attorney

Responsibilities:

• Drafting, reviewing, and advising on compliance policies, procedures, Codes of Conduct, and related governance materials.
• Providing legal and compliance guidance on healthcare compliance matters, including interactions with healthcare professionals (HCPs), conflicts of interest, anti-bribery requirements, the Stark Law, and the Anti-Kickback Statute (AKS).
• Managing conflict of interest programs, including employee and contractor disclosures, COI training materials, review processes, reporting, and program administration.
• Advising clients on compliance audits, assessments, compliance questionnaires, and program effectiveness reviews to evaluate and strengthen ethics and compliance frameworks.
• Conducting and supporting internal investigations involving ethics, compliance, fraud, misconduct, and policy violations, including fact gathering, documentation, risk assessment, and reporting.
• Collaborating with Legal, Quality, Medical, Commercial, HR, Finance, IT, and other stakeholder groups to identify and address compliance risks.
• Developing and delivering compliance training, communications, and awareness initiatives, including e-learning content, live training sessions, guidance materials, and proof-of-training reporting.
• Supporting hotline management, case tracking, risk assessments, monitoring activities, and culture and engagement initiatives.
• Drafting responses to regulatory inquiries and supporting clients in preparation for FDA inspections, audits, and enforcement-related matters.
• Staying ahead of industry trends, regulatory developments, and enforcement activity to provide proactive legal counsel and risk mitigation strategies.

Qualifications:

• 5–10 years of experience practicing law in healthcare, life sciences, ethics and compliance, investigations, regulatory, or related areas.
• Strong knowledge of healthcare compliance regulations, including the Stark Law, Anti-Kickback Statute, anti-corruption requirements, conflict of interest management, and compliance program best practices.
• Proven track record advising clients on compliance programs, investigations, audits, risk assessments, and program effectiveness initiatives.
• Excellent communication, negotiation, technology, analytical, and problem-solving skills, with the ability to manage multiple priorities and stakeholders.
• Juris Doctor (JD) degree or equivalent and active license to practice law in at least one U.S. jurisdiction.

Preferred Skills:

• Experience advising on conflict of interest programs, disclosure systems, and compliance training initiatives.
• Experience conducting fraud, ethics, and compliance investigations and advising on remediation efforts.
• Familiarity with compliance monitoring, auditing methodologies, and regulatory inspections.
• Experience supporting pharmaceutical, biotechnology, medical device, or diagnostics companies.
• Relevant certifications such as Certified Compliance &