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.