Our client company is seeking a REMS lead consultant to support REMS assessment reporting and operations, ensuring compliance with FDA requirements and effective program management.
Responsibilities:
- Prepare the annual REMS assessment report
- Update report templates based on latest FDA feedback and requirements
- Collect, analyze, and summarize data, including creating tables
- Manage project timelines and communicate with stakeholders to resolve issues and risks
- Work with vendors to review REMS data needs
- Create and update REMS documents for FDA submission using tools like Word or Adobe
- Anticipate FDA expectations and help develop regulatory and internal documents
- Oversee daily REMS operations, including responding to pharmacy questions and enrolling new pharmacies
- Maintain the pharmacy database and improve processes
- Help define rules for pharmacy enrollment and removal
- Develop communication and training materials for partners and vendors
- Plan and conduct pharmacy audits, including annual compliance reporting
- Support vendor selection for FDA-required activities and help compare budgets/options
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