Overview
A remote opportunity within the U.S. is available for an Ethics & Compliance Attorney to join a Life Sciences legal team. This role involves providing strategic legal and compliance counsel to clients in pharmaceutical, biotechnology, medical device, and diagnostics sectors. The attorney will support organizations in maintaining effective compliance programs, mitigating risk, and navigating complex regulatory requirements.
Responsibilities
- Draft, review, and advise on compliance policies, procedures, Codes of Conduct, and governance materials.
- Provide legal and compliance guidance on healthcare compliance matters, including interactions with healthcare professionals, conflicts of interest, anti-bribery requirements, the Stark Law, and the Anti-Kickback Statute.
- Manage conflict of interest programs, including disclosures, training materials, review processes, reporting, and administration.
- Advise clients on compliance audits, assessments, questionnaires, and program effectiveness reviews.
- Conduct and support internal investigations related to ethics, compliance, fraud, misconduct, and policy violations.
- Collaborate with Legal, Quality, Medical, Commercial, HR, Finance, IT, and other stakeholders to identify and address compliance risks.
- Develop and deliver compliance training, communications, and awareness initiatives, including e-learning and live sessions.
- Support hotline management, case tracking, risk assessments, monitoring activities, and culture and engagement initiatives.
- Draft responses to regulatory inquiries and assist clients in preparation for FDA inspections, audits, and enforcement matters.
- Stay informed on industry trends, regulatory developments, and enforcement activity to provide proactive counsel and risk mitigation.
Requirements
- 5–10 years of legal experience in healthcare, life sciences, ethics and compliance, investigations, regulatory, or related fields.
- Strong knowledge of healthcare compliance regulations such as the Stark Law, Anti-Kickback Statute, anti-corruption requirements, conflict of interest management, and compliance program best practices.
- Proven experience advising on compliance programs, investigations, audits, risk assessments, and program effectiveness.
- Excellent communication, negotiation, technology, analytical, and problem-solving skills.
- Ability to manage multiple priorities and stakeholders.
- Juris Doctor (JD) degree or equivalent.
- Active license to practice law in at least one U.S. jurisdiction.
Preferred Qualifications
- Experience advising on conflict of interest programs, disclosure systems, and compliance training.
- Experience conducting fraud, ethics, and compliance investigations and advising on remediation.
- 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.
- Experience supporting global compliance programs and cross-functional governance initiatives.
Compensation & Benefits
- Estimated total compensation for full-time attorney roles ranges from $104,500 to $325,000 per year.
- Compensation is based on factors including experience, skills, certifications, location, and business needs.
- Additional benefits may include health, dental, and vision insurance; paid holidays and PTO; flexible work arrangements; and professional development opportunities.
Location
- Remote position within the United States.
Employment may be contingent upon successful background check, proof of identity, and legal authorization to work. Reasonable accommodations are available upon request consistent with applicable laws.