Manager, Compliance Operations

Responsibilities (including, but not limited to):

Reporting to the VP, Head of Compliance, the Manager, Compliance Operations will serve an important role in the ongoing execution and continued enhancement of Kiniksa’s Compliance & Ethics program.

This role is based in our Lexington, MA office and requires employees to be onsite five days per week.

Standout Skills for Impact:

• Assist in the development and planning of Kiniksa’s Compliance & Ethics auditing and monitoring plans to ensure Company compliance with applicable laws, regulations, and Company policies.
• Conduct both live and desktop auditing and monitoring of Medical, Clinical, Commercial, and other departmental activities to ensure compliance with applicable laws, regulations, and Company policies.
• Track and report progress of Compliance & Ethics auditing and monitoring plans, including drafting reports, communicating results, analyzing data, and supporting data analytics.
• Review Needs Assessment Forms (NAFs), including review of any proposed consulting engagements and assessment of Fair Market Value (FMV) requirements.
• Assist with identification and escalation of compliance or ethics issues or allegations which may require investigation, including supporting investigations and assisting with the management of the Company’s Ethics Hotline.
• Provide leadership in helping Kiniksa maintain and further develop a strong culture of compliance and ethics, including driving personal accountability for compliance and ethics.
• Maintain awareness and application of applicable laws, regulations and leading practices for compliance and ethics, and identify opportunities to enhance Kiniksa’s Compliance & Ethics program.

Qualifications and Experience:

• 4+ years in compliance, ethics, audit, monitoring and/or other related experience with biotechnology, pharmaceutical or medical device companies.
• Experience developing and executing compliance and ethics auditing and monitoring activities.
• B.A./B.S. degree or equivalent required.
• Certified Fraud Examiner (CFE), Certified Internal Auditor (CIA), Certified in Healthcare Compliance (CHC), or Project Management Professional (PMP) a plus.
• Knowledge of, and experience with, laws, regulations, and industry guidance that affect the pharmaceutical industry, including but not limited to fraud, waste and abuse regulations, anti-kickback and anti-bribery laws, U.S. Department of Health and Human Services OIG guidelines, transparency and aggregate spend reporting requirements, government settlements (e.g., Corporate Integrity Agreements, Deferred Prosecution Agreements), and state marketing and price reporting compliance laws.
• Strong attention to detail and high-quality work product.
• Project management experience and strong problem-solving skills.
• Ability to work in a fast paced-environment and to handle multiple tasks.
• Track record and commitment to highest compliance and ethical standards.
• Proficient with Microsoft Office suite (Word, PowerPoint, Excel, Outlook, SharePoint, etc.), as well as previous significant experience using report building software (e.g., Tableau, Smartsheet, Cognos Report, Query Studio)
• Ability to travel up to 50%.