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.