Associate REMS Compliance Auditor

United Biosource Corporation•All Virtual Locations, Home Based Position, USA, Remote, US,

4d•Remote

About The Position

The Risk Evaluation and Mitigation Strategy (REMS) Associate Auditor provides core compliance functions and project support for the REMS Stakeholder audit group. Audit support includes communicating with stakeholders such as healthcare settings, pharmacies, and wholesalers/distributors; reviewing audit questionnaires and supporting documentation; and documenting work in the project-specific application. The role has no supervisory responsibility.

Requirements

Minimum associate degree or equivalent work experience.
Strong attention to detail and analytical skills.
Basic understanding of pharmaceutical industry practices, including REMS guidelines and FDA regulatory requirements.
Proficiency in Microsoft Office suite.
Strong organizational and time-management skills.
Willingness to learn and adapt to new processes and regulations.
Ability to work efficiently and prioritize tasks effectively.
Strong problem-solving abilities.
Adherence to ethical standards and confidentiality protocols.
Ability to maintain composure and professionalism under pressure.

Nice To Haves

Bachelor’s degree preferred.

Responsibilities

Serve as a first-line support and single point of contact for REMS stakeholders, communicating consistently and effectively with healthcare settings, pharmacies, and wholesalers/distributors.
Maintain accurate and complete documentation of all contacts.
Review project-specific documentation, including audit plans, project procedures, and work instructions.
Review assigned audit questionnaires within the time constraints specified in each project’s audit plan.
Review submitted documents for completeness, accuracy, and compliance with REMS program requirements.
Follow up on stakeholder audit documentation deficiencies and actions according to client timelines.
Contact stakeholders by phone or email regarding outstanding documentation.
Identify, evaluate, and address audit findings.
Explain audit results to stakeholders.
Complete automated or manual audit review forms accurately to confirm that documentation meets REMS program requirements.
Assist REMS Senior Auditors with continuous quality improvement.
Ensure audit results are formally recorded and reported and that corrective and preventative actions are documented.
Collaborate with REMS Associate Auditors, REMS Auditors, and REMS Senior Auditors to share best practices.
Complete SOP reviews and associated documentation within requested timelines.
Complete client-specific training and documentation within requested timelines.