Manager, Compliance Operations

Responsibilities

• Assist in the development and planning of Compliance & Ethics auditing and monitoring plans
• Conduct live and desktop auditing of Medical, Clinical, Commercial, and other departmental activities
• Track and report progress of auditing plans, including drafting reports and analyzing data
• Review Needs Assessment Forms (NAFs) and assess Fair Market Value (FMV) requirements
• Identify and escalate compliance or ethics issues and support investigations
• Manage the Company’s Ethics Hotline
• Maintain awareness of applicable laws, regulations, and leading practices to enhance the compliance program

Requirements

• 4+ years in compliance, ethics, audit, or monitoring within biotechnology, pharmaceutical, or medical device industries
• Experience developing and executing compliance and ethics auditing and monitoring activities
• B.A./B.S. degree or equivalent
• Knowledge of pharma industry laws including anti-kickback, anti-bribery, and OIG guidelines
• Proficiency with Microsoft Office suite and report building software (e.g., Tableau, Smartsheet, Cognos)
• Ability to travel up to 50%

Preferred Qualifications

• Certified Fraud Examiner (CFE)
• Certified Internal Auditor (CIA)
• Certified in Healthcare Compliance (CHC)
• Project Management Professional (PMP)

About the Company

Kiniksa Pharmaceuticals is a commercial-stage biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications.