Medical writers at Contract Research Organizations (CROs) are playing an increasingly prominent role in writing documents associated with bringing drugs to market - everything from pharmacology reports that summarize testing results for potential new drugs, to safety summaries in New Drug Applications (NDAs) submitted for approval by regulatory bodies. A day in the life of a medical writer consists of producing high quality documents in usually the shortest amount of time possible. Clients, that is, pharmaceutical companies and biotechs, may have a handle on producing and testing the drugs, but it’s the job of the medical writer to tie it up with a pretty bow - presentation is crucial!
With that said, there’s no such thing as a typical day for a medical writer. Every day brings something new. There are, however, some basic steps that most medical writing projects follow. A typical project may start off with a kick-off meeting. For large or complicated projects, an internal kick-off meeting should be the first step so that the entire internal medical writing team is on the same page when client introductions are made. An internal team meeting allows the team to prepare ahead of time in order to provide a united front when meeting with the client, which then gives that client confidence that the team understands the project.
For both the medical writers and the client, one of the most important steps is understanding expectations. Expectations should be laid out as much as possible before writing is even initiated. Such expectations include:
- How many drafts will there be?
- How much input will the client want to provide?
- How often will the client provide input?
- Is publishing included?
There are usually one or two draft deliverables, followed by a final deliverable document. For more straight-forward documents, such as study protocols or clinical study reports, comprehensive templates are usually provided. The client will provide source material, and the medical writer will add information into the corresponding sections. Of course, it’s not just a matter of cutting and pasting. Medical writing requires knowledge of regulatory requirements (for example, knowing what information is required in the efficacy section of a Clinical Overview), experience with client preferences (for agency submissions, client A prefers that all data is presented individually from all phase 1 studies, not just an overall, pooled phase 1 summary), and, yes, a bit of finesse.
It’s the job of the medical writer to “clean up” the deliverable, in other words, perform a spell check, read for fluidity, and adjust the formatting. If these “clean up” steps are not taken, this can prove distracting to the client, who in turn may not be able to focus on providing the necessary feedback on content. It’s like giving someone the most thoughtful present in the world, but doing a sloppy job with the wrapping paper. So, although something like formatting may seem trivial, when not done to the client’s satisfaction, it takes away from the perceived quality of the deliverable, which in turn may lead the client to infer that the content is less than satisfactory as well.
It’s also helpful to provide comment logs with drafts. This allows the writer to communicate exactly what input they need from the client in an organized fashion. By then adding client responses to the log, this can quickly clear up any misunderstood directives, if there are any, and it ensures that the team and the client are on the same page.
By the final draft, any feedback from the client should be integrated into the document. Before it is delivered, it should also go through quality control (QC). This is where the content is checked against sources, which can be anything from an email with wording provided by the client, to the number of adverse events provided in client table, to agreed upon responses in a comment log. Documentation is everything. Remember, if you don’t have proof of an information exchange, then it never really happened!
In the end, clients will come back to a CRO that have medical writers who consistently produce high quality documents in the promised time frame. You can have a quality document, but if it’s a week late, then it does the client no good. Time is money, especially when a company is trying to get a product to market. And the converse is also true - you can have a document done on time, but if it’s less than stellar, then the client may also be inclined to take their business elsewhere. With so many CROs out there, pharmaceutical companies and biotechs have their pick of medical writers to work with, so the key is to consistently produce quality documents in a timely fashion.
Source: MMS Holding
by
Akshaya Srikanth
Pharm.D Resident
Hyderabad, India
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