Lead Risk Evaluation and Mitigation Strategy Consultant
Posted Today by 1775197975
Negotiable
Undetermined
Undetermined
San Jose, California
Summary: The role of the REMS lead consultant involves overseeing the assessment reporting and operations of Risk Evaluation and Mitigation Strategies (REMS) to ensure compliance with FDA regulations. The consultant will manage project timelines, communicate with stakeholders, and prepare necessary documentation for FDA submissions. Additionally, the position requires data analysis, vendor management, and the development of training materials. The consultant will also be responsible for daily REMS operations and pharmacy audits.
Key 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
Key Skills:
- Experience with REMS and FDA compliance
- Strong project management skills
- Data analysis and reporting skills
- Proficiency in Microsoft Word and Adobe
- Excellent communication and stakeholder management abilities
- Ability to develop training materials
- Experience in vendor management
- Knowledge of pharmacy operations
Salary (Rate): £125
City: San Jose
Country: United States
Working Arrangements: undetermined
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
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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