Remote REMS Auditor - Compliance & Stakeholder Liaison

UBC; United States; Remote; USD 70,000 - 95,000; Full time

Benefits offered by this job

Remote opportunities

Growth opportunities for promotion

401K with company match

Discretionary PTO

Paid Holidays

Employee assistance programs

Medical, Dental, and vision coverage

HSA/FSA

Wellness program

Adoption assistance

Short term disability

Long term disability

Life insurance

Discount programs

Job summary

UBC is seeking a REMS Compliance Auditor to support risk evaluation and mitigation strategy audits across remote and home-based locations in the USA. The role involves coordinating with healthcare settings, pharmacies, and distributors to ensure REMS program compliance and accurate documentation.

The ideal candidate will have a 1–2 year background in pharmacy auditing or healthcare compliance, with REMS knowledge and strong Microsoft Office skills.

Qualifications

• Minimum Associate Degree required; Bachelor's preferred or equivalent experience.
• 1-2 years of pharmacy auditing/compliance experience.
• Understanding REMS guidelines and FDA requirements.
• Ability to work independently and maintain confidentiality.
• Proficiency in Microsoft Office suite; strong organization skills.

Responsibilities

• Serve as primary REMS stakeholder contact in healthcare settings, pharmacies, and distributors.
• Maintain thorough and accurate documentation of interactions.
• Review project-specific documentation, including audit plans, procedures, and work instructions.
• Complete timely reviews of assigned audit questionnaires as per project deadlines.
• Conduct document reviews to ensure completeness, accuracy, and compliance with REMS program standards.
• Ensure timely follow-up on audit documentation deficiencies and actions as per client timelines, communicate via phone or email for outstanding documentation.
• Identify, evaluate, and address any audit findings, and articulate results to stakeholders.
• Formally record and report audit results, document corrective and preventive actions.
• Collaborate with REMS Auditors to share best practices.
• Complete SOP reviews and client-specific training within specified timelines consistently.
• Assisting in the development of project-specific documentation, including audit plans, procedures, and work instructions.
• Assisting in training REMS Associate Auditors in program audit techniques.
• Maintain professional communication across all organizational levels, with clients, sponsors, and regulatory authorities.
• Manage multiple tasks and priorities according to business needs.
• Assist in reviewing audit questionnaires and supporting documentation to meet client time constraints.
• Collaborate with REMS Auditors to promote sharing of best practices.
• Conduct on-site audits as requested by clients.
• May support the Global Quality Compliance team with client and regulatory audits.

Skills

Attention to detail

Analytical skills

Independent worker

Time management

Communication

Microsoft Office

Problem solving

Education

Associate degree

Bachelor's degree

Tools

Microsoft Office

Job description

UBC is seeking a REMS Compliance Auditor to support risk evaluation and mitigation strategy audits across remote and home-based locations in the USA. The role involves coordinating with healthcare settings, pharmacies, and distributors to ensure REMS program compliance and accurate documentation.

The ideal candidate will have a 1–2 year background in pharmacy auditing or healthcare compliance, with REMS knowledge and strong Microsoft Office skills.