Activate your Medical Writing Superpowers with Document Development Tools
I’ve previously outlined what I’ve termed your Medical Writing Superpowers (Efficiency, Compliance, Cooperation, Accuracy, Consistency, Presentation, Voice). They are admirable goals for a writer to strive for to improve their deliverables. Next, I am going to run through a series of available technologies to help you try to become a super (or more super) MW.
This is just an overview of different types of tools that can be used to improve your work. It isn’t an exhaustive list, just some options to get you thinking about ways to better balance your working time.
First up, foundational document development tools.
Templates (Activate your powers for Compliance, Consistency, Presentation)
A set of eCTD templates will provide a strong foundation for the wide variety of document types that you’ll encounter as a MW.
The best template sets are comprehensive (hundreds of files), provide explanations of regulatory guidance germane to the document type, and may even provide authoring tips.
While only shells of Word documents, templates can take much of the guess work out of authoring a document and set you up on the right path.
MS Word Formatting Ribbons (Activate your powers for Efficiency, Consistency, Presentation)
As nearly all regulatory documents are written in MS Word, a lack of experience or facility with MS Word can destroy a writer’s efficiency.
All regulatory writers should use an MS Word add-in or ribbon tool.
Clean formatting and proper document construction is essential to giving a positive impression to your team and to your end audience.
Advantages of such tools include consistent styles/formatting, instant TOC, LOT, LOF, section numbering, cross-linking, table formatting, fixing rouge styles, shortcuts, and easier repairing of mal-formatted content.
Often work in conjunction with a set of templates, but can be used on any document.
Examples include both commercially available items and in-house developed tools from CROs and larger Pharma companies. If consulting, the Sponsor should provide access to an in-house product.
If purchasing for yourself or your company, check if the product is macro-based or uses more current programming. Compare feature sets to determine how functions stack up against each other. Figure out how the software is installed and how it can be updated.
Michael Claffey
Chief Operating Officer