One of the many templates I worked on and a very cluttered desk (I need more space)!

Just like that, I am two-thirds of the way through my internship. It hardly seems like 2 minutes ago that I was sitting down to write my first blog. Yet, here I am again, 1 month older and ever so slightly wiser. I decided on the topic of this blog after flicking through my planner and coming across projects in the first few weeks I had already completely forgotten about, followed by notes to myself explaining things which are now common knowledge. It got me thinking that I should summarise some of these notes, and the projects I’ve worked on to help anyone thinking of entering the industry to understand a little bit more about what the job involves. Obviously, I cannot provide specific details of the projects I have worked on, but I hope this will provide an essence of the different projects the role has involved so far and highlight some of the key document types I have come across.

Wax on, wax off

Firstly, I will start where I began, not on live projects but business administration. This largely involved forming templates for documents I would one day be working on, using guidelines from the internet and my new skills on Word to build a document which would then be populated with the content required. Having templates speeds up the whole process by cutting out the formatting side of the role when working on a large document if made correctly everything is there to just begin writing in.

Throughout this process, I was reminded by Bilal of the ‘wax on, wax off’ scene in Karate Kid. I had never seen it before, but I watched it one afternoon and instantly understood the purpose of this exercise. By working out how to make these documents I was not only practising how to use Word (something if you read my first blog you will know I cannot stress the importance of enough), but I was developing consistency and the eye for detail essential for medical writing.

Additionally, I was inadvertently learning the difference between investigator’s brochures (IBs), paediatric study plans (PSPs), clinical study reports (CSRs) and all the different modules required for a new drug application (NDA). To say it wasn’t daunting, seeing the length of some of these documents (50+ pages) before they had even been populated with the information required, would be an understatement. I was terrified by the magnitude of some of these documents, which were projects others in my team were working on seamlessly, but then they have had experience in this field for many more years than I have.

From this exercise, I learnt a lot and I would say to someone entering the industry, learn about these document types now so you become comfortable with the terminology and feel confident talking about them and what regulatory medical writing involves.

Double Time

It is definitely quicker to learn terminology though when you are constantly surrounded by it. I remember first sitting in on a meeting hearing people talk about ‘QCing a document’ thinking, am I dumb? What is that? Only to realise it meant quality control and I now find myself using it without even thinking.

One of the first regulatory projects I helped on was checking the abbreviations in a CSR. This was not a full QC; I was not checking tables against the body of the text to ensure numbers and percentages were stated correctly. I was simply checking that all the abbreviations that were listed in the table were in the body of the text, and vice versa, and ensuring that all abbreviations were defined at first instance only (in both the abstract and the body of the text) and in figure legends. To put it into context, and to give anyone not currently within the industry an idea of how long things take, this took me approximately 15 hours.

Bearing in mind the unpopulated template was over 50 pages long, this was a huge document, and I can understand why I was given this tedious but important job. Consistency is important as a medical writer and jobs like this inadvertently taught me a lot about being consistent whilst learning language styles and the content covered in a CSR.

Now, I’m not saying 15 hours is a reasonable time, I have no clue how long it would take an experienced writer, but I felt at the end I had truly contributed to a project and had learnt a lot that I could bring forward in future projects. For example, there are certain rules regarding what wording you can change and what you cannot from a clinical study protocol (inclusion and exclusion criteria are one of the not examples if you were wondering), and I brought this into a later project and felt pretty pleased that I knew what to do for once.

Around the world in 80 audiences

Medical communications is where I feel I have dipped my toes into a larger variety of projects, and I feel that it is harder to define what the role entails as it is ever-changing. In these 2 months, I have helped on medical transcriptions, populating slide decks (essentially PowerPoint), and building content outlines for sales training videos. Due to the ever-changing target audience, the language and content types are less structured. This provided an additional challenge, as I am still learning, it is hard to know sometimes how to approach a project when there is more flexibility. However, this has allowed me to be slightly more creative and work on a variety of projects in a range of disease areas.

Although I haven’t been able to go into huge detail here, I hope that by highlighting the different documents I have come across and the time that projects have taken, it has provided some level of context to the role. Before I started, I felt at a loss by not really understanding what the day to day role would involve and so I hope this snippet is useful for anyone considering entering into the world of medical writing.

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