Medical writers play a critical role in the drug development process. They work with scientists, clinicians, and regulatory experts to produce clear and concise medical information that is essential for patients and healthcare providers to make informed decisions.
To gain further insight into the challenges of this profession, we sat down with one of Biotrial’s medical writers to explore their methods of collaborating with other departments and how they remain current on the latest industry trends.
Rose: We have the advantage of working with preclinical and clinical teams in the Biotrial Medical Writing Department, as well as a wide variety of sponsors to generate trial documents. These kind of documents include protocols, clinical study reports, medical narratives, annual safety reports, and imaging and biomarker expert reports, and that's on the clinical side. Rose: Then on the non clinical side we have things like study plans and reports. Rose: We also ensure that documents are high-quality through quality checks and editing of documents.
Rose: As medical writers we usually have multiple deliverables with overlapping timelines and we tackle these situations by being proactive. Completing initial stages of document preparation early on, when it's possible, helpsus to reduce the workload as the deadline approach. Rose: Another important step is prioritizing tasks. The urgency of a deliverable will depend on many criteria such as sponsor’s requirements, the stage of the document preperation, etc. Considering these factors, we're able to cater to urgent projects first. Nonetheless, completing all the tasks within the given timelines is always our focus. Rose: Writing regulatory documents involves input from cross-funtional teams. And as we are an international team, we work with clients worldwide and we work in different time zones. Effective communication is really key to navigating these situations. So we clearly outline requests in emails and organize meetings in common time slots and this helps us to get the answers that we need to complete tasks.
Rose: Collaboration is a critical part of what we do in Medical Writing for both clinical and non-clinical deliverables. We collaborate with a wide range of people both internally and on the sponsor side to ensure the documents are high-quality and meet sponsor expectations. Rose: For clinical deliverables, we always interact with the clinical project managers as well as with the different teams involved with the tasks. This could be regulatory, data management, the statisticians, etc. This enriches the discussion and everyone brings their own expertise to the table. Rose: On the non-clinical side, we meet with study directors before writing study plans and reports so that we better understand the study and the results in order to meet the needs of the sponsor
Rose: Our main reference remains the ICH E3 Guidelines, but to stay updated with the latest advancements, we have internal meetings and trainings provided by internal or external experts and there, we can discuss new regulations and guidelines. Rose: If needed we also update the Biotrial templates and, in addition, we regularly participate in webinars from different medical writing associations, so that we can keep up with new information. Rose: We also monitor regulatory updates with the help of our Quality Assurance department.