Heathcare Compliance Operations Manager/ Senior Manager

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!

HEALTHCARE COMPLIANCE OPERATIONS MANAGER OR SENIOR MANAGER 

HCP Engagement | Transparency Reporting | Aggregate Spend | Compliance Systems 
Remote (US) — Boston, MA area preferred 

SUMMARY: 

This position reports to the Assistant Director, Compliance Operations, Systems & Process Lead. The Compliance Operations Manager or Senior Manager supports the day-to-day execution of Ionis’ Healthcare Compliance Operations activities, including HCP engagement operations, transparency reporting, compliance systems, operational data quality, reporting and dashboards, and business process execution.  

This role serves as a key operational partner for core workflows, collaborating across Legal, Finance, Procurement, Medical Affairs, Commercial, IT, Privacy, and external vendors to support compliant, scalable, and efficient operations. The position also supports operational excellence through systems support, training assistance and coordination, technology enablement, and continuous improvement.  

This is a remote role for candidates in the U.S., with preference given to individuals located in or near the Boston, MA area to enable periodic on-site collaboration. 

RESPONSIBILITIES:

• Provide daily Healthcare Compliance Operations support and triage for operational inquiries, including compliance mailbox management, request routing, follow-up tracking, and timely resolution. 
• Support the full HCP engagement lifecycle, including business needs assessments, due diligence, FMV tiering, contracting, and payment documentation 
• Administer HCP engagement and other compliance systems, including user support, configuration coordination, testing, troubleshooting, and issue resolution. 
• Support transparency reporting operations, including data collection, processing, reconciliations, validation, remediation, and reporting readiness for timely and accurate submissions under U.S. federal, state, and ex-U.S. disclosure requirements. 
• Manage operational data quality initiatives and partner with stakeholders to resolve data issues, monitor trends, and strengthen process controls. 
• Develop and maintain SOPs, business rules, process maps, work instructions, FAQs, job aids, training materials, and related communications for HCP engagement and transparency reporting processes and systems; deliver end-user training and onboarding. 
• Coordinate user acceptance testing, system implementations, upgrades, enhancements, and change management activities for compliance-related technologies and workflows. 
• Track KPIs, operational metrics, dashboards, recurring reports, and trends; recommend corrective actions and process improvements. 
• Develop operational reports and presentation materials using HCP engagement and transparency data. 
• Identify automation and emerging digital tools, including AI-enabled workflow solutions, to reduce manual effort, improve user experience, and strengthen controls. 
• Support audit readiness, inspections, internal monitoring activities, and regulatory inquiries by maintaining accurate, complete, audit-ready documentation, system records, and evidence of key controls. 
• Support broader Compliance Operations priorities, cross-functional projects, and other day-to-day operational needs as required (ex. training and communications, compliance ambassador program etc.) 

REQUIREMENTS:

• Bachelor’s degree required
• For the Manager position, at least 2 years of related experience in pharmaceutical, biotechnology, medical device healthcare compliance operations with a Bachelor’s degree
• For the Senior Manager position, at least 5 years of related experience in pharmaceutical, biotechnology, medical device healthcare compliance operations with a Bachelor’s degree (or 3+ years with an advanced degree) 
• Direct experience with HCP engagement, transparency reporting, and compliance systems administration. 
• Strong understanding of HCP engagement lifecycle activities, including business needs assessments, FMV tiering, due diligence, contracting, payment documentation, and related process controls. 
• Experience working with data from multiple systems to identify trends, resolve issues, and generate operational insights. 
• Experience with aggregate spend and transparency reporting, including U.S. federal, state, and ex-U.S. disclosure requirements. 
• Knowledge of healthcare compliance requirements and industry guidance, including the Anti-Kickback Statute, FCPA, PhRMA Code, OIG guidance, and PDMA. 
• Experience implementing, administering, or supporting compliance technologies and digital workflow solutions including AI-enabled tools and other operational technologies 
• Experience with process improvement, system implementation, reporting, or cross-functional initiatives. 
• Strong Excel skills, plus Power BI, Tableau, or similar dashboarding and visualization tools. 
• Ability to translate regulatory requirements into practical, system-enabled processes. 
• High level of integrity and ability to protect proprietary and confidential information. 
• Occasional domestic travel of up to 20%. 

WHAT WE SEEK IN A CANDIDATE: 

• Self-motivated with strong analytical, organizational, and communication skills and able to work independently and collaboratively in a team environment. 
• Ability to work independently and collaboratively in a team environment and convey complex information clearly to diverse audiences. 
• Comfortable managing multiple priorities in a fast-paced, dynamic environment. 
• Agile and willing to take on new projects and additional responsibilities as needed. 

Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition #IONIS004065

Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits

Full Benefits Link: https://ionis.com/careers#:~:text=Highly%20competitive%20benefits

The pay scale for this position is $72,800 to $129,967

The pay scale for the Manager position is $72,800 to $106,562

The pay scale for the Senior Manager position is $90,310 to $129,967

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.