Associate Director, Compliance, Investigations & Monitoring

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

📋 Description

• Oversee the U.S. Compliance Investigations program and manage its daily operations.

• Take ownership of the investigations program framework and collaborate with HR, Legal, Compliance Business Partners, and various stakeholders.

• Establish standards for intake, triage, scoping, documentation, and closure.

• Conduct investigations that include data reviews, interviews, and evidence evaluation.

• Lead the presentation of investigation findings to senior leadership.

• Recommend remediation actions and independently manage cases of varying complexity.

• Interpret policies and carry out remediation efforts such as policy updates, training, coaching, and enhanced monitoring.

• Develop procedures, documentation, templates, guidance, and training for investigations.

• Educate cross-functional colleagues on investigation processes, documentation, and case management expectations.

• Design and continuously enhance the U.S. compliance monitoring program.

• Create and implement risk-based monitoring plans that cover field rides, speaker programs, advisory boards, training sessions, congresses, and promotional or educational events in the market.

• Refine monitoring methodologies and sampling techniques.

• Identify emerging risks, anomalies, and trends through transactional and data-driven monitoring and analytics.

• Develop dashboards and reporting packages.

• Provide periodic monitoring reports to leadership and committees.

• Assist with targeted reviews and foster a strong ethics and compliance culture.

• Collaborate with teams through both virtual and in-person meetings.

⛳️ Requirements

• Juris Doctor (JD) or prior experience in in-house compliance investigations at a pharmaceutical or medical device company.

• 8-12 years of experience advising pharmaceutical, biotechnology, or life sciences companies on compliance issues.

• Extensive experience in conducting internal compliance investigations and managing investigations programs.

• Proficient knowledge and significant experience in U.S. healthcare compliance for prescription products and devices.

• In-depth understanding of pharmaceutical industry regulations and therapeutic areas.

• Familiarity with the Federal Anti-Kickback Statute, False Claims Act, FDCA, OIG/DOJ guidance, PhRMA Code, U.S. state and local marketing compliance laws, and relevant enforcement actions.

• Experience in designing and implementing monitoring programs, including field-based monitoring and data-driven analytics.

• Strong commercial insight and awareness of market dynamics and business culture influences.

• Exceptional analytical and critical thinking abilities, including working with large datasets, identifying trends, and performing big-picture analysis.

• Strong interpersonal, communication, and influencing capabilities.

• Ability to engage effectively with senior leadership and stakeholders at all levels.

• Capacity to manage multiple complex issues in a fast-paced environment.

• Solid project management and organizational skills.

• Ability to handle confidential information responsibly and exercise sound judgment on sensitive investigations and monitoring matters.

• Proven commitment to compliance, ethics, and accountability.

• Willingness to travel up to 30%.

• Must be eligible to work in the United States.

• This position does not provide sponsorship for work authorization.

🏝️ Benefits

• Annual short-term incentive program, subject to plan terms and eligibility requirements.

• Medical, dental, and vision coverage.

• 401(k) plan with employer match.

• Paid time off.

• Competitive compensation.

• Comprehensive benefits.

• Opportunities for growth, development, and collaboration.

• Inclusive and innovative work environment.

• Reasonable accommodations for individuals with disabilities.