SR Manager/Associate Director Med Writing
Regulatory Writing & Document Development
- 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, and establish timelines for deliverables.
- Manage version control and coordinate review cycles to ensure audit-ready completion.
Cross-Functional Collaboration
- Partner with clinical, statistical, regulatory, safety, and technical teams to ensure accuracy, consistency, and timely delivery of documents.
Data Interpretation & Narrative Development
- Translate complex clinical and statistical data into clear, compliant narratives aligned with submission objectives.
Compliance & Continuous Improvement
- Ensure adherence to global regulatory standards, internal guidelines, and style conventions.
- Support template enhancements and process optimization initiatives.
Submission & Inspection Readiness
- Drive quality checks, maintain traceability to source data, and reconcile comments to ensure readiness for regulatory review.
Milestone & Risk Management
- Monitor timelines and risks, escalate issues proactively, and implement solutions to maintain delivery commitments.
FAQs
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