Job Responsibilities

• Compiles, writes, edits, and coordinates medical writing deliverables that present scientific information clearly and accurately, and works as a medical writer within and across departments with moderate supervision.
• Completes a variety of documents that may include clinical study protocols and protocol amendments; clinical study reports; patient narratives; and investigator brochures.
• Adheres to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, company and/or client-approved templates, authorship requirements, and style and formatting guides, when completing medical writing projects, on time and on budget.
• Coordinates quality and editorial reviews. Ensures source documentation is managed appropriately. Leads document reviews, reviews documents as needed, and resolves comments from client.
• Reviews statistical analysis plans and table/f...