6 Things All Medical Writers Should Do
As a medical writer within a multidisciplinary team, there are several ways that you can help pave the way for successful document development. The project kick-off meeting is a great place to start. Having a kick-off meeting is extremely helpful to both the writer and the team as a whole. No matter how small the project or how tight the team, it is important to have a meeting to establish the proposed project flow and launch the project from an agreed upon footing. Here are some steps to ensure a great project launch:
Develop timelines. Have a template that you can rely on that covers typical steps in development. Be as thorough as possible. If you can’t put dates to everything yet, at least have expected durations for milestones.
Know all the cooks in the kitchen. List out the team members for each step of the process. This includes content contributors, team reviewers, senior management reviewers, partners/consultants, and approvers. Identify all contributing functions and flag any unknowns to be added later.
Speak to all steps. Does the document require publishing? Has a QC or QA step been factored in? Will translation need to occur? Be prepared to explain the utility of these steps and make sure that the timeline accounts for them.
Educate the team on dynamic processes. Discuss how reviews will be conducted and what platform or modality will be used. Discuss authorship control of the master file. Understand who will control and edit the timelines and where they will be stored/shared.
Account for data. If data or reports are part of the document development plan, then discuss the timing, location, distribution, and availability of these materials.
Finally, ask questions. A kick-off meeting is a great opportunity to learn critical aspects of the project from the people who know it best. People like to share their expertise, but they just might need to be asked to do so.
Teamwork is key. You don’t necessarily have to do this all yourself. If you have a strong, engaged, and experienced team, then these project set-up steps may be handled by various team members. Plan ahead with your points of contact to ensure a comprehensive planning and kick-off process. If needed, though, this is an opportunity for you as the medical writer to fill the void. You know what to do and what is needed, so lead the way. Your job will be easier for it.
Michael Claffey
VP, Acumen