
Records & Information Governance Specialist
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Overview
Job Description
Job Description:
The Records & Information Governance Specialist will support the development, implementation, and maintenance of Xeris's enterprise-wide records retention and information governance program. This role supports compliance with SEC requirements and FDA/GxP regulatory frameworks, including clinical, pharmacovigilance, manufacturing, and quality records. The position also contributes to privacy, data governance, and other information compliance initiatives across the Company.
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 regulatory requirements applicable to a public biopharmaceutical company.
- Partner with Legal, Quality, Regulatory, IT, and business stakeholders to ensure proper record classification, retention, and disposition.
- Support management of GxP records, including clinical trial documentation, manufacturing batch records, pharmacovigilance data, and quality system records.
- Monitor compliance and assist with audits, inspections, and internal reviews related to recordkeeping.
- Execute defensible records disposition and deletion processes.
- Administer legal hold processes including tracking, notices, and coordination with Legal and IT.
- Assist with document preservation, collection, and organization for litigation, investigations, and regulatory inquiries.
- Support privacy program efforts including data mapping, records inventories, and data subject request responses.
- Assist with incident response tracking and documentation for data privacy events.
- Support data governance initiatives including classification, lifecycle management, and Redundant, Obsolete, Trivial/Transitory, (ROT) data reduction.
- Develop training materials and provide guidance to employees on records retention, privacy, and data governance requirements. Draft/disseminate employee communications accordingly.
- Maintain audit-ready documentation of retention, privacy, and governance activities.
Skills and Qualifications
- Bachelor's degree required.
- 5+ years of relevant experience in records management, compliance, privacy, or information governance.
- Familiarity with GxP and FDA-regulated recordkeeping requirements in the life sciences industry preferred.
- Working knowledge of privacy laws (e.g., CCPA/CPRA, GDPR, etc.) preferred.
- Experience with legal holds, eDiscovery, or compliance programs is a plus.
- Strong organizational, communication, and analytical skills.
- Ability to manage confidential information with discretion.
Working Conditions
- Position may require periodic evening and weekend work, as necessary to fulfill obligations.
- Must be able to travel occasionally to off-site record retention facilities to conduct inventory-related activities. Activities may include standing for several hours at a time, and lifting, and carrying boxes.
- This is a hybrid position based in Xeris' Chicago office. A minimum of three days per week in the office is required. On-site requirements may change at management's discretion.
The anticipated base salary range for this position is $91,000.00 to $114,000.
#LI-HYBRID
Xeris Pharmaceuticals, Inc. (the "Company") is an equal opportunity employer and does not discriminate based on race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. All qualified candidates are given equal opportunity and the Company's employment selection decisions are based solely on job-related factors. NOTE: This job description is not intended to be all-inclusive. The employee may be required to perform other related duties as needed to meet the ongoing needs of the Company.
The level of the position will be determined based on the selected candidate's qualifications and experience. Final determination of the actual base salary offered depends on several factors, including but not limited to the candidate's skills, experience, education, location, and business needs. Employees are eligible for equity or long-term incentive awards, where applicable. Field Sales role employees are eligible for a quarterly commission structure. Non-Sales role employees are eligible for an annual bonus. The Company also offers a comprehensive benefits package that includes additional elements such as paid time off benefits, various health, vision, and dental insurance options, 401(k) retirement benefits and more for eligible employees. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process. Individuals hired as temporary employees, interns, and preceptors are not eligible for commissions, bonuses, and/or long-term incentive or equity awards. Eligibility for other benefits will be based on plan documents.
Accessibility & Reasonable Accommodations
If, because of a medical condition or disability, you require a reasonable accommodation or assistance to complete any part of the application process, please send an e-mail to recruiting@xerispharma.com and identify the type of accommodation or assistance you are requesting. Please include the job requisition number in your message. Please note if your request is not for this stated purpose, you will not receive a response to your email. Do not include any medical or health information in this email.
Xeris participates in E-Verify. E-Verify Participation Poster
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FAQs About Records & Information Governance Specialist Jobs at Xeris Pharmaceuticals
- Alternate-schedule
- Full-time