Abstract
Regulatory documents are complex beasts, often requiring input from many different authors. Sometimes, different departments will be responsible for authoring certain sections and the role of the medical writer could perhaps be more accurately described as a coordinating editor, who manages timelines and ensures that the contributors are aware of what is expected of them. Regardless of the amount of writing a medical writer actually does on a document, he or she will need to usher the document through at least one review cycle with multiple reviewers before sign-off can happen.
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