Remote REMS Auditor for Pharmaceutical Compliance

United Biosource Corporation; United States; Remote; USD 65,000 - 90,000; 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

United Biosource Corporation (UBC) is seeking a REMS Compliance Auditor to support risk evaluation and mitigation strategies across multiple client sites. The role involves coordinating with healthcare settings, pharmacies, and distributors to review audit questionnaires and document findings in project systems.

You will ensure audits meet REMS standards, maintain thorough documentation, and assist in training new hires. Remote, home-based position with potential on-site visits as requested.

Qualifications

• Minimum Associate Degree required; Bachelor’s Degree preferred or equivalent work experience.
• 1-2 years of experience in pharmacy auditing, compliance, or a related field within the pharmaceutical and/or healthcare industry.
• Understanding of REMS guidelines and FDA regulatory requirements.
• Ability to work independently without supervision.
• Strong attention to detail and analytical skills.
• 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.

Responsibilities

• Act as the primary REMS stakeholder point of contact with healthcare settings, pharmacies, and distributors.
• Maintain thorough and accurate documentation of all interactions.
• Review project-specific documentation, including audit plans and procedures.
• Complete timely reviews of assigned audit questionnaires per deadlines.
• Conduct document reviews to ensure REMS compliance.
• Follow up on audit documentation deficiencies and client timelines.
• Identify and address audit findings and report results to stakeholders.
• Record and report audit results and corrective actions.
• Collaborate with REMS Auditors to share best practices.
• Complete SOP reviews and client-specific training within timelines.
• Assist in developing project-specific documentation and training REMS Associate Auditors.
• Maintain professional communication across organizational levels.

Skills

Pharmacy auditing

Regulatory compliance

Attention to detail

Microsoft Office

Communication

Independent work

Time management

Problem solving

Confidentiality

Education

Associate degree

Bachelor’s degree preferred

Tools

Microsoft Office

Job description

United Biosource Corporation (UBC) is seeking a REMS Compliance Auditor to support risk evaluation and mitigation strategies across multiple client sites. The role involves coordinating with healthcare settings, pharmacies, and distributors to review audit questionnaires and document findings in project systems.

You will ensure audits meet REMS standards, maintain thorough documentation, and assist in training new hires. Remote, home-based position with potential on-site visits as requested.