Assistant/Associate Director, Compliance Operations, Systems & Process Lead

Role Summary

The Assistant / Associate Director Compliance Operations – Systems and Process Lead, reports to the Head of Compliance Operations and is responsible for designing, implementing, and managing technology and process solutions supporting Ionis’s healthcare fraud and abuse compliance operations. Key focus areas include HCP Engagements, Transparency Reporting, Risk Assessment, and Monitoring. This role ensures compliance systems and processes are efficient, scalable, and aligned with regulatory requirements and company policies.

This role is flexible for remote candidates in the U.S., with preference given to individuals located in or near the Boston, MA area to enable periodic on-site collaboration. The position partners cross-functionally with Commercial, Medical, R&D, IT, Legal, Finance, Procurement and HR to promote a strong culture of ethics and compliance while driving digital innovation and operational excellence.

Responsibilities

• Serve as the system owner and operational lead for compliance tools, including HCP Engagements, Transparency Reporting, Risk Assessment, and Monitoring, Case Management/Hotline system
• Oversee daily operations, system configuration, user access, and data governance to ensure accuracy, reliability, and audit readiness
• Translate business processes into compliance system requirements and configurations through cross-functional collaboration
• Lead the RFP process with compliance system vendors and manage vendor performance, contracts, and budgets
• Manage upgrades, enhancements and change control processes
• Provide guidance on transparency data capture and transparency reporting workflows to support accurate data for transparency reporting and audit readiness
• Identify opportunities to automate manual compliance processes and streamline workflows
• Partner with IT teams to deploy AI-enabled tools and digital workflows that improve efficiency and risk detection
• Develop compliance dashboards and analytics to provide actionable insights
• Create and maintain process documentation, SOPs, and job aides ensuring consistent execution of compliance processes
• Provide end-user training, communications, and change management to drive adoption of new technologies
• Conduct monitoring activities (live, transactional, and desktop) to assess compliance with company policies, procedures and regulatory requirements

Qualifications

• Bachelor‚Äôs degree required
• For the Assistant Director position, 8 years of experience in healthcare compliance operations, specifically risk and system management, within the biopharmaceutical industry, or 6 years; with an advanced degree, relevant compliance certifications is a plus; other related experience may be considered
• For the Associate Director position, 12 years of experience in healthcare compliance operations, specifically risk and system management, within the biopharmaceutical industry, or 8 years; with an advanced degree, relevant compliance certifications is a plus; other related experience may be considered
• Proven experience implementing and managing healthcare compliance risk management technologies and processes
• Expertise in system configuration, data governance, and process optimization
• Excellent problem-solving skills with attention to detail and accuracy
• Strong project management and vendor management experience
• Experience with laws, regulations and industry guidance that affect the pharmaceutical industry including, but not limited to, OIG and PhRMA guidelines, healthcare standard operating procedures, transparency reporting, an anti-bribery and anti-kickback laws
• Demonstrated ability to leverage technology (including AI/ML) to automate compliance tasks and identify risks
• Proficiency in Excel; experience with Tableau, Power BI, or similar data analytics tools preferred
• Strong analytical skills with ability to work with large datasets to identify trends and compliance risks
• Ability to translate regulatory requirements into practical, system-enabled processes
• Strong verbal and written communication skills to clearly convey complex information to diverse audiences
• Self-motivated, and able to work independently as well as collaboratively in a team environment
• Agility to take on new projects and additional responsibilities, as required
• High level of integrity with the ability to maintain the protection of proprietary and confidential information
• Ability to work in a fast paced and dynamic work environment with a strong work ethic and positive attitude
• Occasional domestic travel (up to 20%)