Life Sciences Ethics and Compliance Attorney

This is a fully remote position, open to applicants in United States.

📋 Description

• Preparing, evaluating, and providing counsel on compliance policies, processes, Codes of Conduct, and relevant governance documentation.

• Offering legal and compliance advice on healthcare-related compliance issues, including interactions with healthcare professionals (HCPs), conflicts of interest, anti-bribery standards, the Stark Law, and the Anti-Kickback Statute (AKS).

• Overseeing conflict of interest programs, which encompass employee and contractor disclosures, COI training materials, review procedures, reporting, and program management.

• Guiding clients through compliance audits, assessments, compliance questionnaires, and program effectiveness reviews to assess and enhance ethics and compliance frameworks.

• Conducting and assisting with internal investigations related to ethics, compliance, fraud, misconduct, and policy breaches, including information gathering, documentation, risk evaluation, and reporting.

• Collaborating with Legal, Quality, Medical, Commercial, HR, Finance, IT, and other stakeholder groups to pinpoint and mitigate compliance risks.

• Creating and implementing compliance training, communication, and awareness initiatives, including e-learning modules, live training sessions, guidance documentation, and proof-of-training reporting.

• Assisting in hotline management, case tracking, risk assessments, monitoring activities, and culture and engagement initiatives.

• Composing responses to regulatory inquiries and aiding clients in their preparation for FDA inspections, audits, and enforcement-related matters.

• Keeping informed on industry trends, regulatory changes, and enforcement activities to provide proactive legal advice and risk mitigation strategies.

⛳️ Requirements

• 5–10 years of legal experience in healthcare, life sciences, ethics and compliance, investigations, regulatory, or related fields.

• In-depth knowledge of healthcare compliance regulations, including the Stark Law, Anti-Kickback Statute, anti-corruption standards, management of conflicts of interest, and best practices for compliance programs.

• Demonstrated success in advising clients on compliance programs, investigations, audits, risk assessments, and initiatives for program effectiveness.

• Exceptional communication, negotiation, technological, analytical, and problem-solving skills, with the capability to handle multiple priorities and stakeholders.

• Juris Doctor (JD) degree or equivalent and a current license to practice law in at least one U.S. jurisdiction.

🏝️ Benefits

• Health, dental, and vision insurance

• Paid holidays and PTO

• Flexible work arrangements

• Opportunities and resources for professional development