Assistant / Associate Director, Compliance Operations, Systems & Process Lead
Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We're pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals.
At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know that our success is a direct result of the exceptional talents and dedication of our employees.
With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money and energy into making our onsite, hybrid and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive.
We're building on our rich history, and we believe our greatest achievements are ahead of us. If you're passionate about the opportunity to have meaningful impact on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you develop and expand your career!
ASSISTANT DIRECTOR or ASSOCIATE DIRECTOR, COMPLIANCE OPERATIONS SYSTEMS & PROCESS LEAD
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
Requirements
Bachelor's degree requiredFor 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 consideredFor 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 consideredProven experience implementing and managing healthcare compliance risk management technologies and processesExpertise in system configuration, data governance, and process optimizationExcellent problem-solving skills with attention to detail and accuracyStrong project management and vendor management experienceExperience 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 lawsDemonstrated ability to leverage technology (including AI / ML) to automate compliance tasks and identify risksProficiency in Excel; experience with Tableau, Power BI, or similar data analytics tools preferredStrong analytical skills with ability to work with large datasets to identify trends and compliance risksAbility to translate regulatory requirements into practical, system-enabled processesStrong verbal and written communication skills to clearly convey complex information to diverse audiencesSelf-motivated, and able to work independently as well as collaboratively in a team environmentAgility to take on new projects and additional responsibilities, as requiredHigh level of integrity with the ability to maintain the protection of proprietary and confidential informationAbility to work in a fast paced and dynamic work environment with a strong work ethic and positive attitudeOccasional domestic travel (up to 20%)