Associate Compliance Auditor, REMS
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Job Description
Associate REMS Auditor supporting pharmaceutical compliance audits for UBC, a drug-development and commercialization services company. Reviewing stakeholder documentation, questionnaires, findings, and REMS compliance requirements.
Responsibilities:
- Provide consistent and effective communication with REMS stakeholders as first-line support and single point of contact
- Maintain accurate and complete documentation of all contacts
- Review audit plans, project-specific procedures, work instructions, audit questionnaires, and supporting documentation
- Complete assigned audit questionnaire reviews within project audit-plan timelines
- Review submitted documentation for completeness, accuracy, and REMS program compliance
- Follow up on documentation deficiencies and actions according to client timelines
- Communicate with stakeholders by phone or email regarding outstanding documentation
- Identify, evaluate, and address audit findings
- Explain audit results to stakeholders
- Complete automated or manual audit review forms
- Assist REMS Senior Auditors with continuous quality improvement
- Record and report audit results and document corrective/preventive actions
- Collaborate with REMS Associate, Auditor, and Senior Auditor teams to share best practices
- Complete SOP review and client-specific training documentation within required timelines
- No supervisory responsibility
Requirements:
- Minimum Associate Degree required; Bachelor’s Degree preferred or equivalent work experience
- Basic understanding of pharmaceutical industry practices, including Risk Evaluation and Mitigation Strategies (REMS) guidelines and FDA regulatory requirements
- Proficiency in Microsoft Office suite
- Strong attention to detail and analytical skills
- 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
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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