Senior REMS Auditor & Team Lead - Remote

United Biosource Corporation; United States; Remote; USD 90,000 - 130,000; Full time

Benefits offered by this job

Remote opportunities

401K with company match*

Flexible work environment

Paid Holidays

Job summary

United Biosource Corporation is seeking a Senior REMS Compliance Auditor with supervisory experience. The role oversees REMS audits, trains new hires, and liaises with healthcare settings, pharmacies, and distributors to ensure REMS compliance. It involves reviewing audit questionnaires, documentation, and client communications.

The Senior Auditor oversees up to five direct reports and collaborates with REMS teams to improve quality and ensure timely audits across virtual and on-site engagements.

Qualifications

• Bachelor’s Degree preferred.
• At least three (3) years of experience in pharmacy auditing, compliance, or related field in pharma/healthcare.
• Strong understanding of REMS guidelines and FDA regulatory requirements and industry standards.
• Ability to work independently without supervision.
• Strong attention to detail and analytical skills.
• Proficiency in Microsoft Office suite.

Responsibilities

• Provide clear communication to REMS stakeholders in healthcare settings, pharmacies, and distributors.
• Maintain thorough documentation of all interactions.
• Review audit plans, procedures, and work instructions.
• Complete timely reviews of audit questionnaires per project deadlines.
• Conduct document reviews for completeness, accuracy, and REMS compliance.
• Follow up on documentation deficiencies with clients and document actions.

Skills

REMS knowledge

Audit coordination

Regulatory communications

Project management

Quality improvement

Education

Bachelor's degree

Tools

Microsoft Office

Job description

United Biosource Corporation is seeking a Senior REMS Compliance Auditor with supervisory experience. The role oversees REMS audits, trains new hires, and liaises with healthcare settings, pharmacies, and distributors to ensure REMS compliance. It involves reviewing audit questionnaires, documentation, and client communications.

The Senior Auditor oversees up to five direct reports and collaborates with REMS teams to improve quality and ensure timely audits across virtual and on-site engagements.