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Regulatory Medical Writing

Regulatory Medical Writing: How to Manage Multiple Projects?

Regulatory Medical Writing involves writing a study protocol and/or a clinical study report (CSR) of a project. However, sometimes the medical writer has to tackle multiple projects with converging deadlines and all the study teams demanding more and more of his time.

So, here are the medical writing tips to manage multiple projects efficiently.

  • Identify the documents which are the most urgent and have the highest impact in a study. Prioritize them over those with the least impact.
  • Assign a timeline to yourself with all the overlaying projects. This will help you identify the gaps in your workload and where you might need support.
  • Explain the entire document completion process to the study team at the beginning of the project. Ask them for any changes to be made beforehand. Show them how large changes, ad hoc reviews etc. in the end can affect the timelines.
  • Write the methods section of the CSR once the client finalises the protocol and statistical analysis plan.
  • For writing CSRs, hold a results review meeting with the study team where you show them the way you plan to present the data. Discuss your opinions about the key messages and conclusions.  This will help you know what the the study team wants exactly and how it must be presented.
  • Take help from your colleagues to complete the projects with converging timelines. For example, as the lead medical writer, you can write the efficacy results more accurately, but you can assign a large in-text table or the safety section to your colleague.
  • Once you have completed the first draft of your document, call the study team for a live meeting and discuss. Any disagreements from the study team will be apparent at an early stage and you can resolve them quickly, thus moving the document swiftly to the next stage.
  • Do not hurry and wait till you receive all the client’s comments. Their comments may help resolve team contradictions. Moreover, while waiting you can work on another project from another client. Also, make sure you know the signatories of the study project.
  • Inform your QC and peer reviewers about any changes in the timeline changes. If you wish to deliver all your documents on time, you must ensure that all the reviewers know when they will be required to complete the work, how long will it take, and the degree of urgency of the project.
  • Finally, be honest with your clients. Irrespective of how much projects you have, do not agree with a client if he has unrealistic expectations. Work with him to change the deadlines or document writing process as far as possible. A client knows better how to make changes so as to deliver the document on time rather than late.

With these tips in hand, you need not worry about the deadlines of your projects. Because now you will be a master who can handle multiple projects at one time.

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