Risk Management and Compliance Specialist
2 weeks ago
Contract Duration: 5-6 months
Working Hours: Flexible EST hours (Options available from 8 AM to 5 PM or 9 AM to 5 PM, Monday to Friday)
Work Arrangement: Remote (Occasional on-site presence may be required for inspections)
Position Overview:
The ideal candidate will possess a comprehensive understanding of Risk Evaluation and Mitigation Strategies (REMS), including the preparation of REMS Assessment documentation and Risk Management Monitoring (RMM) in compliance with applicable regulations and Standard Operating Procedures (SOPs).
Familiarity with FDA guidelines is essential.
Applicants should have a minimum of 5 years of experience in the pharmaceutical industry, with a focus on drug safety, risk management, or epidemiology, including at least 2 years of hands-on REMS experience.
Experience in overseeing REMS audits is mandatory.
The candidate should demonstrate proven expertise in direct engagement with REMS initiatives.
Acting as a subject matter expert on REMS is a key requirement for this role.
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