A Regulatory Medical Writer in a Clinical Research Organization (CRO) is usually involved at the start (writing a study protocol) and/or end (writing a clinical study report(CSR)) of a project. The start and end of a clinical study can be the most stressful time for the team as they work together to meet important deadlines. For the Medical Writer this stress can be further exaggerated by multiple projects converging and study teams demanding more and more of their time with last minute changes. The Medical Writer, as part of a team, will also have to do their fair share of quality control (QC) and/or peer reviewing.
Medical Writing Tips to help manage projects efficiently
- Manage time effectively by identifying which documents are the most urgent (could have the highest knock-on effect in a study), and which can be delayed with the least impact.
- Draw yourself a timeline with all your projects overlaying each other, this immediately lets you see where there are gaps in your workload and where you might need support.
- At the start of a project explain the entire document completion process to the study team; show how large changes, ad hoc reviews etc. can eat into critical QC time. If a client deviates from the agreed process you can remind them that it might affect the timelines.
- Do as much work as you can off the critical path, for instance, you can always write the methods section of the CSR once the protocol and statistical analysis plan are final. Likewise, clients often have generic sections of protocols that they carry through a set of studies.
- For CSRs, hold a results review meeting and show, with table shells, how you plan to present the data. Discuss what you believe are the key messages and conclusions. This gives the study team the chance to tell you exactly what they want and stops you wasting time on in-text tables that they will just delete.
- If timelines are converging utilise your colleagues. As the Lead Medical Writer you will probably be in the best position to write the efficacy results, but a colleague could easily complete a large in-text table, or perhaps write a safety section.
- Once you have written the document ask study teams to work through it with you via a live meeting or face to face. This allows disagreements to be discussed and resolved quickly. Furthermore, if you make the necessary changes in the document during the meeting you can move the document swiftly to the next stage.
- Always wait until you have received all the client’s comments before addressing them and make sure you know who the signatories are. Their comments are likely to be the ones that resolve team contradictions. While you are waiting for comments, you can be working on another study.
- Make sure your QC and peer reviewer are aware of any timeline changes. For all of your documents to be delivered on time you need to ensure that all reviewers are aware of when they will be required to complete the work, and if possible an estimate on how long it should take. You should also tell them how urgent it is.
- Finally, regardless of how much work you have, be honest - if a client has unrealistic expectations work with them to change these. A client would rather know how to help bring a project in on time then for it to be late.