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A day in the life of a regulatory medical writer

Regulatory medical writers help produce accurate documents for submission to regulatory bodies. We work on various documents such as protocols, clinical study reports, briefing books, common technical documents (CTD) modules, etc. Our work is important because we help new medical devices and drugs reach patients. You can consider us as a bridge between pharmaceutical companies and regulatory agencies.

Starting the day with growth training

It's log-on time and I kickstart my day with growth training. It is taken by our company Managing Director, Bilal Bham, who is passionate about his team growing in all aspects of their life. He takes us through some of the concepts. I feel super energised and motivated to start my day.

Organising and structuring a briefing book

Today I am starting to work on a briefing book, for which I had a client call yesterday. Our client is a biotechnology company in the USA that needs the briefing book for correspondence with the Food and Drug Adminstration (FDA) about their drug. I check my inbox and feel happy to see that the source documents have been shared which means that I can begin work on the briefing book draft today. I quickly download all the documents and check if we have all we need. I spot that some of the data has still not arrived, so I write a quick email to our client to request the data.

Myself, Ivy, and Gauri (both senior medical writers) have an internal call to discuss the briefing book structure. We place the FDA guidance document in the folder and start working on the draft. We divide the work into sections and start working. I am working on the background section today which means that I need to go through a lot of scientific literature. This section should be logical and flow smoothly to effectively introduce our drug. I check the data provided and start writing.

Perks of working for a remote company

It has been 4 hours now and it's nearly evening chai time. Oh, did I tell you that I am working from India? At Bham Pharma, we have this amazing perk (my favourite) to work from anywhere in the world. Bham Pharma is a fully remote company and offers this unique flexibility to its employees.

After my chai and samosa, I go for an evening stroll in a nearby park. The air is smelling sweet as magnolia trees are laden with flowers. I catch the glorious sun setting over the horizon.

Importance of data accuracy in regulatory medical writing

Feeling fully refreshed, I get back to my work. With my mind working faster and sharper after my stroll, it's the perfect time to check the data against the sources. This is a very important part of work for a regulatory medical writer. Our work needs to be precise and has no room for error. Satisfied after checking (and rechecking) my data, I incorporate some diagrams and figures in my draft to make it interesting and easily understandable.

It has been around 2 hours and I see a training notification in my email. I attend the training and feel better informed about the new guidelines that have come up in the context of medical devices regulatory writing. After the training, I update the slide deck that I am going to present at the Junior Medical Writer training.

I also search for some articles regarding a blog I am writing. At Bham Pharma, we have this unique opportunity to also learn about Medcomms and this blog is one of the ways I am learning about this division.

I inform my colleagues about the progress I have made with the briefing book. We quickly chat over our plan of action for the next day. It is time to log off now. So, there you have it, a glimpse into the day of a regulatory medical writer!
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Varsha Toshniwal
Medical Writer II & Medical Devices Lead