Writing clinical and regulatory documents involves input from the arenas of clinical and nonclinical operations, regulatory compliance, biostatistics, pharmacokinetics, safety, quality assurance, and project management. However, the writer can complete the bulk of the text, with functional groups acting as experts, advisors, and reviewers. Peer-to-peer verbal discussions or bullet points from the functional experts can provide the information needed for more difficult sections of the document, so that functional experts do not need to write paragraphs. Thus, having the bulk of the text written by a medical writer not only produces a higher quality document in less time, but also frees up the functional staff to focus on their primary roles and responsibilities. The experience of writing a large number and variety of documents allows the medical writer to plan ahead for the writing of the future NDA/CTD. Each document is written as a chapter in the NDA/CTD by incorporating position statements that are supported by study results. Position statements define the value of the study and may relate to study rationale, design, patient population, conduct, results, or conclusions. When combined, the position statements link the various documents together and tell the story of the NDA/CTD. Consistency is a key to planning for the NDA/CTD, and is supported by well-designed templates, boilerplate language, and style guides that are created by the medical writer to be used throughout the drug development process without dramatic revision. Consistency is vital when discussing results and conclusions from a given study in multiple documents, and uniform data presentation between clinical study reports allows results and conclusions to be more easily combined when integrating the summaries for the NDA/CTD. Consistency can be easily lost when multiple functional experts write individual sections of documents. Furthermore, the medical writer can control the master document, facilitating version control and maintaining document stability (i.e., prevention of document corruption).

Because highly skilled medical writers drive the writing process, and in general write and type faster than the functional staff, they can complete a document in less time. Time is important, since delays in finalizing a document often amplify and can cause serious consequences downstream, potentially compromising clinical operations and regulatory submissions.

Coordinating the Document Review Process
The medical writer is the ideal person to coordinate the document review process. Drafts of a clinical and regulatory document are typically reviewed by all functional research areas, management, and other interested parties. The medical writer and the document owner (usually a medical monitor) compile, prioritize, and categorize (accept, reject, or need discussion) suggestions by the reviewers. A better written document generates fewer reviewer comments and thus reduces both the review and comment resolution time. The highly skilled medical writer can also provide reviewers with the rationale for why their specific suggestions were rejected, allowing the reviewers to know that their comments were not ignored and making it less likely that they will make the same suggestion on the next draft. Suggestions that cannot be easily resolved are discussed as a group at a comment resolution meeting. The medical writer can run these meetings, guide the discussion, and record the group consensus and/or decisions, which are then used to write the next draft.

Identifying and Obtaining Literature References
Establishing and maintaining processes and databases related to reference articles are important for the efficient preparation of clinical and regulatory documents, and are critical for the preparation of an NDA/CTD. Highly skilled medical writers have vast experience searching literature databases and reading scientific and medical literature; thus, they are capable of finding and obtaining references that support specific concepts or statements in the text.