Now, 3 months into my new role as Head of Regulatory Writing at Alchemy, people are asking me how the job compares between a pharmaceutical company and a medical writing agency? Here, I briefly review my career, and try to answer that question from my own perspective.
I became a regulatory medical writer at a major pharmaceutical company following a science degree, a PhD, and about 5 years post-doctoral lab work. I stayed in that role, at the same company for a further 23 years, until earlier this year when I took up the new role at Alchemy.
I found the work of a regulatory medical writer at a pharmaceutical company interesting and stimulating, and it allowed me to learn my trade from extremely talented and bright people. The type of documents that I was writing changed with each merger, acquisition, and reorganisation. I wrote common technical documents (CTD), briefing documents, and regulatory responses when the medical writing team was placed in the regulatory department. When we were placed in the safety department, I wrote periodic safety update reports (PSURs), risk management plans (RMPs), annual safety reports (ASRs), and label updates. Latterly, when we were placed in the clinical department, I wrote clinical study reports and protocols. There was no need to change job, because the job changed itself.
What’s more, the company was surprisingly flexible. They allowed me to remain part‑time when I returned after maternity leave. They even allowed me to move 200 miles away and work from home when my husband relocated. I worked flexible hours, allowing me to pick the kids up from school, just like I always hoped that I would. And this was all at a time that you didn’t see part-time, work-from-home jobs advertised.
But things moved on. I found myself over-qualified for my role, expensive, and outside the go-forward geographic footprint of the company. Not only that, but my kids had grown up, and I started to get the feeling it was time for me to please myself. So, when I inevitably got my marching orders at the next reorganisation, it didn’t take long to realise an opportunity hadbeen laid at my door.
Alchemy had caught my eye a couple of years previously. It was the friendly, accepting, and professional image that made me follow the company, and to connect with Lesley, its founder. So, when I saw that they were advertising, it seemed like a case of now or never. Now I have been here for nearly 3 months, and wow, my feet have hardly touched the ground. But how do the 2 work environments compare?
One key similarity is timelines. Once a project is started, the documents still need to be completed asap. That reflects the competitive nature of the business. It goes with the territory. However at Alchemy, although we still have an assigned document owner there is more emphasis on collective responsibility for documents, so that if a particular document needs to take priority to get it over the line, others can step in and help out.
Once a project is started, the documents still need to be completed ASAP. That reflects the competitive nature of the business. It goes with the territory. However, at Alchemy, there is more collective responsibility for documents. So, others can step in and help out to get it over the line.
Other things are reassuringly familiar too. When you’ve worked at one company for so long, you start to wonder if your functional knowledge is company specific, or does everyone do it that way? But now I know, a summary of clinical safety (SCS), is an SCS, is an SCS… The issues that arise are the same, it’s just the solutions that may need to be adapted.
And client teams still consist of the familiar characters. I don’t just mean the standard roles of clinicians, regulatory lead, medical lead, statistician, etc., but the range of personalities. Mind you, the discussions are a bit more guarded when you don’t all work for the same company.
As for the wider work experience, it has been a bit of a revelation to me that there is a network of small- and medium-sized companies out there, all working for each other in an inter-woven layer of the economy that I’d never paid much attention to. Familiar roles that are ‘in-house’ at a large company are fulfilled by contractors. External IT consultants, human resources consultants, and communications and graphics specialists are all brought together to simulate a larger modular company. These are all experts in their field with the determination and enterprise to run their own companies and are so interesting to work with.
The biggest practical difference I would say between big pharma and the agency environment is the concept of time tracking. We did this at the previous company of course, but now it feels like every single minute counts, and without wishing to state the obvious, it makes you so much more aware of how you spend your time. As soon as I realise that I’m starting to lose focus on a task, I now change my activity so as not to waste any time. I like to think I’m more efficient.
The biggest practical difference between big pharma and the agency environment is the concept of time tracking. Now every single minute counts and it really does make you aware of how you spend your time. I like to think that I’m more efficient now.
Another big difference is that at the pharmaceutical company we generally knew what was coming our way at least a year in advance. It wasn’t always the case, but generally your whole year was planned out. You could start early on documents, get up to speed with the background, and author shell documents. In an agency environment there seems to be much less lead time. About half of the work seems to be requested only once its urgent. You never know what is going to drop in the inbox.
Another important difference between a large pharmaceutical company and Alchemy is siloes, or rather, the lack of them. My experience of big pharma is that, by necessity of scale, tasks become specialised. Specific, but related tasks may get split between different job roles, which may be in different departments, which may be on a totally different branch of the organogram – in other words operating in complete isolation. But in a small agency, the same author or same small group can potentially write the protocol, the ICF, the CSR, the lay language summary, and the corresponding manuscript, as well as the subsequent CTD documents. It doesn’t have to be split between Clinical, Regulatory, and Medical Affairs departments. This makes for efficiencies as well as variety in the role.
Another important difference is the lack of siloes. By necessity of scale, tasks in big pharma jobs become specialised. But in a small agency, the same small group can write everything from the protocol and ICF to the lay language summary and corresponding manuscript. It makes for a variable role!
And finally, there are the things I have done since I joined Alchemy that I had never had the opportunity to do in all my years at big pharma. Dealing with contracts, estimates, interviewing, walking alpacas through the Scottish rain, making fresh pasta with a celebrity chef… and yes, writing my first blog!
I felt welcome from the very first day at Alchemy, and under the leadership of Lesley, Adam, Lee-Anne, and Jess, the place has a wonderful family feel. From the cheery good mornings in the team IM chat, to weekly virtual coffee meetings to exchange business updates as well as sharing streaming recommendations and holiday snaps, they recognise the importance of having permission to be yourself. That way, the best work gets done. That is hard to achieve in a large company.
