When people ask what we do as regulatory medical writers, I tell them we write all sorts of documents related to clinical trials:
✍The protocol about how the clinical trial will be executed
✍The investigator’s brochure with everything relevant that is known yet about the compound
✍The report with all the clinical trial results
✍The risk management plan describing the product’s safety profile and plans to prevent or minimize specific risks
✍And many more documents
But in fact, that does not really grasp the whole of what we actually do. Apart from writing these documents, we provide significant added value to the entire document or project:
✅ We develop a plan of approach. The customer comes to us with a query for a document, but does not always have a clear idea of where to start or how to proceed. Once we understand the needs and expectations of the customer, we propose realistic timelines with a step-by-step approach to reach our combined goal. We manage a project from start to end and adhere to the agreed deadlines.
✅ We know our way through the elaborate pool of regulatory guidance documents. We make sure that every document we write adheres to the latest requirements. We follow continuous training and keep an eye out for any new developments, so that we stay up-to-date in the field of medical writing and can share that knowledge with people in other functions when needed.
✅ We provide expertise. Medical writers know what is needed to provide a qualitative document and what health authorities expect. We strive to describe scientific data in a clear and comprehensive way. A well-written document is no guarantee of approval, but it will assure ease of review and easier decision making.
✅ As medical writers, we are the ones who bring it all together. We may not be experts on the compound, but we are experts in finding all relevant information and combining it in one well-structured document. We know whom to reach out to for specific questions in order to use everyone’s precious time effectively. If input from the entire team is needed, we organize efficient meetings.
✅ We always adhere to our own scientific and ethical integrity. Our mission is to be transparent and to present all content in an objective, correct, and comprehensive way, as all documents we write may have a broad impact on the community.
✅ We are the ones who keep the overview and bring consistency into a document. Can you imagine the confusion if one part of a document gives different instructions compared with another part? Do you remember those group assignments in school, where you clearly noticed which part was written by a different person? We make sure that does not happen! We continuously guard consistency, both within a document and in related documents.
✅ We apply the finishing touches. Medical writers may be inherent nitpickers. We make sure that the customer does not need to bother about punctuation, typo’s, or formatting. Some people may think it is tiresome to check all this, but for most medical writers, it is a natural instinct.
If you ask me what a medical writer actually does, I would say that we provide support and expertise to deliver qualitative, consistent documents in the most efficient way.