Essential Job Functions
- Administer records retention and information governance program, including policies, procedures, and retention schedules.
- Maintain retention schedules aligned with FDA (GxP), SEC, and other applicable regulatory requirements.
- Partner with Legal, Quality, Regulatory, IT, and business stakeholders for record classification, retention, and disposition.
- Support GxP record management (clinical trial documentation, manufacturing batch records, pharmacovigilance data, quality system records).
- Monitor compliance and assist with audits, inspections, and internal reviews.
- Execute defensible records disposition/deletion processes.
- Administer legal hold processes (tracking, notices, coordination with Legal and IT).
- Assist with document preservation/collection for litigation, investigations, and regulatory inquiries.
- Support privacy program efforts (data mapping, records inventories, data subject request responses) and privacy incident documentation.
- Support data governance (classification, lifecycle management, ROT data reduction).
- Develop training materials and guidance; draft/disseminate employee communications.
- Maintain audit-ready documentation.
Skills and Qualifications
- Bachelorβs degree required.
- 5+ years in records management, compliance, privacy, or information governance.
- Familiarity with GxP/FDA-regulated recordkeeping preferred.
- Privacy laws knowledge (e.g., CCPA/CPRA, GDPR) preferred.
- Legal holds/eDiscovery/compliance program experience a plus.
- Strong organizational, communication, and analytical skills; discretion with confidential information.
Working Conditions
- Periodic evening/weekend work; occasional travel to off-site facilities (may require lifting/carrying boxes).
- Hybrid (Chicago office), minimum three days/week.
Compensation/Benefits
- Anticipated base salary range: $91,000β$114,000. Benefits include paid time off, health/vision/dental insurance options, and 401(k), where eligible.
Application Instructions
- For reasonable accommodation during the application process: email recruiting@xerispharma.com with the job requisition number; do not include medical/health information.