Remote REMS Compliance Auditor - Growth & Impact

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

Benefits offered by this job

Remote opportunities

401K with company match

Paid Time Off

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 an Associate REMS Compliance Auditor to support the REMS stakeholder audit group. The role focuses on ensuring audit documentation, communication with stakeholders, and adherence to REMS program requirements while working in a remote, home-based setting in the USA.

You will review audit plans, questionnaires, and supporting materials; maintain records; and collaborate with REMS teams to drive timely, compliant outcomes, with a focus on accuracy,

Qualifications

• Associate degree required; bachelor’s degree preferred.
• Strong attention to detail and analytical skills.
• Basic understanding of pharmaceutical industry practices, REMS guidelines, and FDA 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.
• Strong problem-solving abilities and confidentiality commitment.

Responsibilities

• Provide clear communication to REMS stakeholders as first line contact with REMS stakeholders.
• Maintain accurate documentation of all contacts.
• Review project documentation that may include audit plans and procedures.
• Complete review of all audit questionnaires within the time constraints listed in the audit plan.
• Conduct document review of submitted documentation for completeness and REMS program compliance.
• Ensure follow-up of audit documentation deficiencies and actions per client timelines.
• Communicate with stakeholders via phone or email for documentation still outstanding.
• Identify, evaluate, and address any audit findings.
• Articulate and explain audit results to stakeholders.
• Accurately complete the audit review form to ensure documentation meets REMS requirements.
• Assist in development of continuous quality improvement with REMS Senior Auditors.
• Ensure audit results are recorded and corrective/preventive actions documented.
• Collaborate with REMS team to share best practices.
• Complete SOP reviews and client training within timelines.

Job description

United Biosource Corporation (UBC) is seeking an Associate REMS Compliance Auditor to support the REMS stakeholder audit group. The role focuses on ensuring audit documentation, communication with stakeholders, and adherence to REMS program requirements while working in a remote, home-based setting in the USA.

You will review audit plans, questionnaires, and supporting materials; maintain records; and collaborate with REMS teams to drive timely, compliant outcomes, with a focus on accuracy,