Once upon a time, regulatory writing for drug development programs followed a scheduled routine and involved clearly defined roles. The writers wrote all the non-clinical and clinical documentation, and then the reviewers reviewed it. With the advent of collaborative authoring technology, that process went by the wayside. Initial drafts are frequently written in collaboration with team members who would have previously been classified in a review role.
What is collaborative authoring in regulatory submissions?
Collaborative authoring is a process where multiple medical communications team members contribute to documents that support the approval and marketing of pharmaceutical products. This approach involves using online tools and platforms that allow simultaneous editing, commenting, and tracking of changes by different authors and reviewers. Collaborative authoring can reduce the time and effort required to produce high-quality regulatory documents and improve the accuracy and consistency of the information across the submission.
Tips to help regulatory writers with this new way of working
Experienced authors know that concerns can arise from this approach. “Will the team judge draft content that isn’t yet polished?” “What if they review rather than author?” “How will I maintain version control?”
Luckily, you can preempt these issues by following a few key tips and tricks for collaborative authoring.
- Set expectations—It’s essential to set expectations for the collaborative authoring process just like you would for the review process. The details will be project-specific but consider the following: Assign specific content to specific team members or indicate that you’ll generate initial drafts of content and will reach out to collaborative authors when you’re ready for their revisions. Be clear that this is the time to make direct changes to the text (or to provide comments instructing text changes) and not the time to review.
It may be helpful to establish informal timelines for different collaboration steps. Ensure the team knows that content in a collaborative authoring draft won’t have been QC’d, and any typos should be forgiven. Making sure everyone is on the same page in advance will set you up for success as authoring progresses. - Be flexible—Some team members will undoubtedly deviate from your expectations. Get ahead of this by checking in on the draft often. When deviations are likely to lead to inefficiencies, reach out to those team members, remind them about the agreed-upon process, and educate them on its rationale. And when deviations occur that aren’t likely to lead to inefficiencies, let it go.
If a team member prefers to provide their content offline rather than in the collaborative document, add it to the master document for them. If a team member prefers to put their suggested revisions in comment bubbles, add those revisions to the text for them. You’ll be surprised by how smoothly collaborative authoring can proceed with these minor accommodations. - Use the technology—Most collaborative authoring platforms offer helpful tools to take advantage of. The most common of these is an @ feature that allows you to flag specific team members for specific content or questions and notifies those team members when you do so. This is a huge time saver, removing the need for back-and-forth emails or meetings in many cases. Be sure to upload external sources and references to the collaborative working space, as needed, and link to them in communications with the team. Using these tools in addition to the Word tools we’re used to will facilitate efficient communication.
Parting thoughts for medical writing success
You’re the writing expert; be the collaborative authoring expert, too. Then use that expertise to guide the team through the collaborative authoring process. This blog is a great starting point for building that expertise, and you’ll develop your preferred ways of working and tips and tricks for collaborative authoring as you gain experience working this way. You’ve got this!
Watch this webinar to learn more about how technology is being used to streamline the drug development process.