Risk Management Consultant

Job Summary

To support a growing client partnership, the full-time Manager, Risk Management Consultant will oversee the development and operational execution of Risk Evaluation and Mitigation Strategies (REMS) while ensuring compliance and stakeholder engagement in a contract role with potential for extension.

Key Responsibilities

• Support the development, implementation, and monitoring of REMS and U.S. risk management strategies
• Coordinate REMS Core Team governance and provide program updates to stakeholders
• Maintain inspection-ready documentation and support audits, inspections, and regulatory correspondence

Required Qualifications

• Bachelor's degree (life sciences preferred)
• Minimum of 3 years of relevant experience, including at least 1 year in REMS or related fields
• Knowledge of FDA regulatory requirements across the prescription drug development lifecycle
• Experience managing third-party vendors, contracts, and budgets in a regulated environment
• Proficiency with data reconciliation and electronic document regulatory information management systems