REMS Compliance Auditor
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Job Description
REMS Auditor supporting pharmaceutical compliance audits for UBC’s drug development and commercialization services. Reviewing stakeholder documentation, recording findings, and supporting regulatory-quality initiatives.
Responsibilities:
- Provide effective communication to 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 according to project deadlines
- Conduct document reviews for completeness, accuracy, and compliance with REMS program standards
- Follow up on audit documentation deficiencies and actions within client timelines via phone or email
- Identify, evaluate, and address audit findings and communicate results to stakeholders
- Complete audit review forms to verify adherence to REMS program requirements
- Formally record and report audit results and document corrective and preventive actions
- Collaborate with REMS Auditors to share and promote best practices
- Complete SOP reviews and client-specific training within specified timelines
- Assist in developing project-specific audit plans, procedures, and work instructions
- Assist in training REMS Associate Auditors in program audit techniques
- Maintain professional communication with organizational levels, clients, sponsors, and regulatory authorities
- Manage multiple tasks and priorities according to business needs
- Conduct on-site audits as requested by clients
- Support the Global Quality Compliance team with client and regulatory audits when needed
- No supervisory responsibility
Requirements:
- 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 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
- GxP and/or healthcare industry experience highly preferred
Benefits:
- Remote opportunities
- Competitive salaries
- Growth opportunities for promotion
- 401K with company match*
- Tuition reimbursement
- Flexible work environment
- Discretionary PTO (Paid Time Off)
- Paid Holidays
- Employee assistance programs
- Medical, Dental, and vision coverage
- HSA/FSA
- Telemedicine (Virtual doctor appointments)
- Wellness program
- Adoption assistance
- Short term disability
- Long term disability
- Life insurance
- Discount programs
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