Associate Director, Compliance, Investigations & Monitoring

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

📋 Description

• Oversee the U.S. Compliance Investigations program, ensuring investigations are conducted in a timely, consistent, fair, and well-documented manner.

• Manage the framework of the investigations program and collaborate with HR, Legal, and essential partners.

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

• Perform investigations through data analysis, interviews, and evidence evaluation.

• Present investigation summaries to senior leadership and suggest corrective actions.

• Independently address matters of varying complexity.

• Collaborate with Compliance Business Partners and cross-functional stakeholders to interpret policies and execute remediation strategies.

• Create procedures, documentation, templates, guidance, and training related to investigations.

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

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

• Develop and implement risk-based monitoring plans that encompass field rides, speaker programs, advisory boards, training sessions, congresses, and promotional or educational events.

• Improve monitoring methodologies and sampling techniques.

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

• Create dashboards and reporting packages.

• Provide regular monitoring reports to leadership and committees.

• Facilitate targeted reviews and foster a robust ethics and compliance culture.

⛳️ Requirements

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

• 8-12 years of experience providing compliance advice to pharmaceutical, biotechnology, or life sciences companies.

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

• Proven expertise in advising on U.S. healthcare compliance for prescription products and devices.

• Comprehensive 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 pertinent enforcement actions.

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

• Strong commercial insight and grasp of market dynamics and the influence of business culture.

• Exceptional analytical and critical thinking abilities, including the capacity to analyze large datasets, identify trends, and conduct big-picture analysis.

• Strong interpersonal, communication, and influencing skills.

• Capability to manage multiple complex matters in a fast-paced environment.

• Excellent project management and organizational skills.

• Ability to handle confidential information responsibly and exercise sound judgment.

• Proven commitment to compliance, ethics, and accountability.

• Willingness to travel up to 30% of the time.

• External candidates must be authorized to work in the United States.

• This position does not provide sponsorship for work authorization.

🏝️ Benefits

• Annual short-term incentive program, contingent upon plan terms and eligibility criteria.

• Comprehensive medical, dental, and vision insurance.

• 401(k) plan with employer contributions.

• Paid time off.

• Competitive salary.

• Meaningful opportunities for personal growth, professional development, and collaboration.

• An inclusive and innovative workplace.

• Reasonable accommodations available for individuals with disabilities.