For a period of time I was the only medical writer in a small contract research organization (CRO), working closely with the regulatory affairs department. I learned some project management skills that, I later realized, are valuable tools for writing large, complex regulatory documents.
Regulatory documents, such as clinical study reports, clinical summaries, and overviews, require many interconnected deliverables from numerous team members with constantly shifting timelines. Any delay in one deliverable can potentially result in a large downstream effect. The regulatory writer is a juggler who has to keep all the balls in the air in order to meet her own deadline. This is where project management tools come in handy.
One of the most used tools by project managers is the Gantt chart. It may look complex and tedious upon first glance. However, after creating a few Gantt chart myself in Microsoft Project, my entire thinking about the process of medical writing shifted.
The Gantt chart forces you to focus on the most important elements in a timeline: 1) the rate-limiting steps, 2) the key people, 3) the high-risk tasks. The rate limiting steps are the deliverables that can hold up your work if they are not provided on time. A good example is the final tables and listings or pharmacokinetic results for a study report. The key people are those without whom you can't get the document finished, including the signatories and QC checkers. The high-risk tasks are steps that are most likely disrupted or delayed. For example, if you have under-estimated the days you need to write a draft or a section, you may become the delay. If you keep your eyes on these 3 elements continually, the rest is cruising.
Even if you don't have MS Project and do not want to create and maintain your own Gantt chart, drawing a diagram of your timeline from time to time can be a useful mental exercise. It often clears your mind and simplifies a project that seems overwhelmingly complex.
Perhaps most valuable in the exercise is the psychological benefit of managing your own timeline: As a writer I get a sense of control of the documents I'm working on over a long time; at any moment I know exactly what I need, when, and from whom. If I have slipped behind a little, I can make micro-adjustments as soon as possible and never have to "cram" in the end, thus creating a smooth and pleasant experience.
Regulatory documents, such as clinical study reports, clinical summaries, and overviews, require many interconnected deliverables from numerous team members with constantly shifting timelines. Any delay in one deliverable can potentially result in a large downstream effect. The regulatory writer is a juggler who has to keep all the balls in the air in order to meet her own deadline. This is where project management tools come in handy.
One of the most used tools by project managers is the Gantt chart. It may look complex and tedious upon first glance. However, after creating a few Gantt chart myself in Microsoft Project, my entire thinking about the process of medical writing shifted.
The Gantt chart forces you to focus on the most important elements in a timeline: 1) the rate-limiting steps, 2) the key people, 3) the high-risk tasks. The rate limiting steps are the deliverables that can hold up your work if they are not provided on time. A good example is the final tables and listings or pharmacokinetic results for a study report. The key people are those without whom you can't get the document finished, including the signatories and QC checkers. The high-risk tasks are steps that are most likely disrupted or delayed. For example, if you have under-estimated the days you need to write a draft or a section, you may become the delay. If you keep your eyes on these 3 elements continually, the rest is cruising.
Even if you don't have MS Project and do not want to create and maintain your own Gantt chart, drawing a diagram of your timeline from time to time can be a useful mental exercise. It often clears your mind and simplifies a project that seems overwhelmingly complex.
Perhaps most valuable in the exercise is the psychological benefit of managing your own timeline: As a writer I get a sense of control of the documents I'm working on over a long time; at any moment I know exactly what I need, when, and from whom. If I have slipped behind a little, I can make micro-adjustments as soon as possible and never have to "cram" in the end, thus creating a smooth and pleasant experience.
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