- 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).
