SR Manager/Associate Director Med Writing - Boston
1 month ago
Job Summary
Lead the creation of key regulatory documents including clinical overviews summaries and study-specific content for major submissions Draft and update clinical study reports investigator brochures and standard operating procedures Contribute to protocols amendments statistical analysis outputs briefing materials and responses to regulatory inquiries Document Planning & Project Oversight Define document strategies develop outlines establish timelines for deliverables Manage version control coordinate review cycles to ensure audit-ready completion Cross-Functional Collaboration Partner with clinical statistical regulatory safety technical teams to ensure accuracy consistency timely delivery of documents Data Interpretation & Narrative Development Translate complex clinical statistical data into clear compliant narratives aligned submission objectives Compliance Continuous Improvement Ensure adherence global regulatory standards internal guidelines style conventions Support template enhancements process optimization initiatives Submission Inspection Readiness Drive quality checks maintain traceability source data reconcile comments ensure readiness regulatory review Milestone Risk Management Monitor timelines risks escalate issues proactively implement solutions maintain delivery commitmentsJob description
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