Heathcare Compliance Operations Manager/ Senior Manager

Ionis Pharmaceuticals, Inc.•Boston, MA

18d•$72,800 - $129,967•Remote

About The Position

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.

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%.

Nice To Haves

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.

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.)