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.
Requirements
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 & Ethics Professional (CCEP), Certified Fraud Examiner (CFE), or similar credentials.
Experience supporting global compliance programs and cross-functional compliance governance initiatives.
Benefits
About Axiom:Health insuranceDental insuranceVision insurancePaid time offRemote work optionsFlexible schedule
Additional Information
Join Our Team as an Ethics & Compliance Attorney at Axiom
Location: Remote (U.S.)
We are seeking Ethics & Compliance Attorneys to join our Life Sciences team. In this role, you will provide strategic legal and compliance counsel to pharmaceutical, biotechnology, medical device, and diagnostics clients, helping organizations maintain effective compliance programs, mitigate risk, and navigate complex regulatory requirements. This position offers a unique opportunity to collaborate with leading life sciences companies on global compliance initiatives, investigations, auditing activities, and program effectiveness efforts. This is an existing vacancy.
Axiomtalentplatform · Remote