Content Writer

• Author and maintain PMS documentation including PMSPs, PMSRs, and PSURs for assigned product portfolios
• Gather and compile information from Clinical Affairs, Regulatory Affairs, Risk Management, Marketing, Quality, and other stakeholders
• Analyze and summarize post-market surveillance, complaint, vigilance, clinical, and risk management data to develop regulatory-compliant safety summaries and trend analyses
• Support literature reviews and post-market surveillance activities
• Conduct public database searches for adverse events, recalls, and competitor safety information
• Perform data collection, quality checks, and basic analysis to support PSUR development
• Review, trend, and analyze relevant safety and performance data to support conclusions documented within PMSRs and PSURs
• Maintain documentation within the Quality Management System
• Identify potential timeline, quality, or data risks affecting assigned reports and communicate mitigation plans to management
• Contribute to the development, maintenance, and continuous improvement of PMS and PSUR-related procedures, work instructions, templates, and guidance documents
• Identify opportunities to improve document quality, consistency, and efficiency within PMS reporting processes
• Ensure documentation is maintained in accordance with Quality Management System requirements and current regulatory expectations
• Support EU MDR compliance activities related to PMS documentation
• Participate in cross-functional meetings and project discussions
• Perform other duties as assigned

Explore PSUR Writer II at CooperCompanies. Review requirements and application details.