Associate REMS Auditor
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Job Description
Associate REMS Auditor supporting stakeholder audits, documentation review, and FDA/REMS compliance. UBC provides pharmaceutical support services across drug development and commercialization.
Responsibilities:
- Provide consistent and effective communication to all appropriate REMS stakeholders as first line support/single point of contact
- Maintain accurate and complete documentation of all contacts
- Review project-specific documentation, including audit plans, procedures, and work instructions
- Complete assigned audit questionnaire reviews within project audit-plan timelines
- Review submitted documentation for completeness, accuracy, and REMS program compliance
- Follow up on stakeholder audit documentation deficiencies and actions according to client timelines
- Communicate via phone or email regarding outstanding documentation
- Identify, evaluate, and address audit findings
- Articulate and explain audit results to stakeholders
- Complete automated or manual audit review forms accurately
- Assist REMS Senior Auditors with continuous quality improvement
- Ensure audit results are formally recorded and reported, including corrective/preventative actions
- Collaborate with REMS Associate, Auditor, and Senior Auditor teams to share best practices
- Complete SOP review and documentation within requested timelines
- Complete client-specific training and documentation within requested timelines
- Support compliance functions and projects for the REMS Stakeholder audit group
Requirements:
- Minimum Associate Degree required; Bachelor’s Degree preferred or equivalent work experience
- Strong attention to detail and analytical skills
- Basic understanding of pharmaceutical industry practices, including Risk Evaluation and Mitigation Strategies [REMS] guidelines and FDA regulatory 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 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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