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UBC · 19 hours ago

Senior REMS Compliance Auditor - Supervisor

United States

Full-time

Remote

Mid, Senior Level

3+ years exp

UBC is a pharmaceutical support industry leader devoted to empowering health solutions for a better tomorrow. They are seeking an experienced Senior REMS Compliance Auditor to oversee Associate REMS Auditors and REMS Auditors, ensuring compliance and effective communication with stakeholders during audits.

BiotechnologyHealth CareLife ScienceMedical

Responsibilities

Consistently provide effective communication to all relevant stakeholders as the primary point of contact for REMS stakeholders in healthcare settings, pharmacies, and wholesalers/distributors

Maintain thorough and accurate documentation of all 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

Accurately complete audit review forms to verify adherence to REMS program requirements

Assist in continuous quality improvement efforts with REMS Auditors

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

Develop project-specific documentation such as audit plans, procedures, and work instructions

Provide program audit training to REMS Associate Auditors, ensure comprehensive coverage of project and soft skills

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

Guide audit teams in addressing audit findings and contribute to continuous quality improvement initiatives with REMS Management and Project Management

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

Qualification

Pharmacy auditingREMS guidelinesFDA regulatory requirementsMicrosoft OfficeAnalytical skillsOrganizational skillsProblem-solving abilitiesAttention to detailTime managementCommunication skills

Required

At least three (3) years of experience in pharmacy auditing, compliance, or a related field within the pharmaceutical and/or healthcare industry

Strong understanding of pharmaceutical industry practices, including Risk Evaluation and Mitigation Strategies [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

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