Roles of highly-skilled medical writers

Highly-skilled medical writers can add substantial value to the discovery and development process for drug and device companies.  Here are some key roles they fill:

• Writing the bulk of the text:  The bulk of the writing can be completed by the medical writer, with functional groups acting primarily as experts, advisors, and reviewers.  Medical writers are skilled in presenting a consistent story within and across documents and will follow the template, style guide, and publishing requirements.  In addition, completing the document will be the top priority for the medical writer. The result is better documents faster.
• Analyzing data:   Highly-skilled medical writers are capable of thoroughly and accurately analyzing complex data and should participate in every aspect of data analysis including data review meetings, review of the statistical analysis plan, and review of mock tables, figures, and listings. 
• Coordinating the document review process:  The medical writer is the ideal person to distribute drafts, collate comments, run the document review meetings, and resolve issues in collaboration with key decision makers.
• Performing literature searches:  Highly-skilled medical writers are capable of performing complex literature searches on specific subjects, analyzing the information obtained, and preparing a summary. On a smaller scale, the medical writer can find and obtain scientific and/or medical references that support specific concepts or statements in the document. In addition, the medical writer is well positioned to add citations to the text, prepare the document reference list, obtain the reference articles, maintain the literature database, and upload reference articles to the publishing group.
• Coordinating the appendices process:  The  medical writer is the best person to identify, locate, store, and distribute document appendices since the medical writer has relationships with all of the document owners, access to many of the master or published documents, and knows the history of the project (eg, number of protocol amendments).