How do Medical Writers actually work?

MedComms is a mysterious industry. It’s very hidden if you don’t work in it already.

I’m Eleanor Steele and I’m the MedComms Mentor, and I want to open up this mysterious world, and today I’m focusing on how medical writers actually work.

So, what they do day to day and how they work with other people.

This follows on from last week’s video, where I was looking at the types of projects that we do in MedComms. Now, different agencies work in different ways and have different structures, so always ask about how things work in that particular agency if you are interviewing or talking about a potential job.

This video might help you think of the questions that you want to ask and the kind of responses you might be hoping for.

I want to start off with how medical writers are assigned work. So MedComms is a varied industry and there are lots of factors that might come into play when work is being given out.

Smaller, newer agencies might work on individual projects, so be working with a range of clients, but on individual discrete pieces of work – a slide deck here, a meeting there. In this kind of model, you are likely to pick up work partly because you have the capacity at the right time, and partly because it fits your experience best.

Once that project comes to an end, you’ll be assigned something else to fill the gap, but it could be completely different and you may well be working with different people in the agency team on each project, or even everyone in the agency might be involved in every project if it’s really small.

Bigger MedComms agencies are usually structured into teams that include Medical Writers, Client Services people, and potentially other roles with senior support.

They have long term work from particular pharma clients known as ‘accounts’. There are lots of different types of work a pharma client might need an agency to do, which I covered in last week’s video.

So usually, an account will focus on one area, like publications or maybe meetings support. Sometimes an account will be really big and several teams within the agency might be involved in handling separate aspects, or the team itself might be really big so that it can cover all of the work.

Teams within the agency might work on one big account or several smaller ones. Sometimes people will be on one team, sometimes you’ll split your time between different teams – different agencies handle these things differently.

Medical Writers will be assigned specific projects within their account. Most agencies try to make sure the same writer stays with a project from beginning to end, as it helps ensure consistency for the content, but it also encourages ownership and career development for the writer involved. Sometimes deadlines or competing priorities might mean that projects have to be passed between writers, but that’s usually a last resort.

The senior Scientific and Client Services people on the team will usually come together on a regular basis to look at the projects that are planned out and figure out who is best placed to do the work.

Once a project is ready to kick off, the assigned writer will then need to be briefed.

As a Medical Writer, you will never be told to just go off and write a piece of content without any other information – there will always be something to get you going. This can be variable, but every project will have some kind of scope agreed with the client, and a budget, which will specify what tasks have been agreed within that scope, and how much time has been assigned to each of these tasks. The scope and budget will normally be put together by Client Services in collaboration with senior Scientific team members, and will be used as the starting point for a brief for the Medical Writer.

Depending on the size and structure of your team, you might be briefed by a Scientific Director or maybe just another writer, but the brief will normally be written by a more senior member of the team on your account.

The brief should include the basic admin side of things, like which project code you should use to track your time on timesheets – that’s how the agency makes money after all.

There would also normally be instructions on what needs to be done, how long each task should take from the budget, and depending on your level of experience, how you need to do those tasks.

That’s why a brief is normally written by someone with more experience. They can use that experience to explain the rationale for what’s been agreed in the scope, break down different approaches you could use to do those tasks, and maybe include some tips and tricks or pitfalls to avoid.

The brief we get as Medical Writers is a cornerstone of on-the-job training, and we can learn so much from those briefs if they’re put together in the right way, which is not easy, and that’s something I’m going to be covering in future videos.

But getting back to this topic, a good brief will include examples of similar projects so you don’t have to reinvent the wheel.

These examples are so helpful because they can show us things like the level of detail we should be using, guide our language choices, maybe give us ideas of different visual ways of presenting information. All of these things are so important to make sure the content will be appropriate for the audience, but writing out instructions for each of these things could take hours, whereas a couple of examples will get the message across much more easily.

A good brief might also include source materials, so this could be key references that you’ll need, or data tables, maybe internal client document – things that you’re going to need for the content development.

But it might also include things like a style guide, laying out all of the style and format requirements for that particular client. This could be things like whether it’s UK or US English, how references should be formatted, what symbols to use for footnotes, spelling out key abbreviations, specific colours or fonts you need to use, punctuation preferences – all sorts of fiddly details.

Style guides can be somewhat epic. So the really good ones have a short summary of the key information you are likely to need when you’re writing the content, which is what we’re coming onto now.

Once you’ve got your brief and read it through, you obviously need to follow it to create the content. That sounds so simple, but there will usually need to be a conversation about how exactly you’ll be translating that brief into the content with the person who briefed you, and it’s always best to ask questions before you get started so you don’t get stuck waiting for the answers!

Exactly how you approach the content is going to vary.

Everyone has a different writing process, and the vast array of different types of project that medical writers work on means it’s really hard to give any step-by-step breakdown of how the writing process actually happens.

However, no matter what you are working on, there are two things you should bear in mind throughout the writing process.

The first is the audience you are writing the content for, and the second is the objective for that audience – so what you are trying to get across to them.

You can use those two elements whenever you are struggling with how to phrase something or how to present a piece of information, maybe even to choose which information to include – focusing on your audience and your objective will help you find the right path.

One other thing that’s fairly consistent across medical writing projects is that as we create content, we will be using sources, so mainly published references, but maybe also data tables or clinical study reports, maybe other internal client documents – basically the evidence base for the project that we’re working on.

While we are writing that content, we normally need to create a marked up reference pack of all of the evidence supporting that content. There are lots of ways this might be done, but it basically creates a resource where someone can go through the content that you’ve written and quickly find the source of that data point or statement.

This is a crucial part of the quality control processes for MedComms agencies, and different agencies handle it differently, but the likelihood is that as a Medical Writer, you will need to data check your colleagues’ work occasionally.

It’s also a job that’s often given to new Medical Writers because it’s a fantastic introduction to the whole job, so obviously the data itself and the references, but also how to make a good reference pack so that it’s easy to check the data, and an overview of the different types of projects that your team works on.

OK, so you’ve written the first draft of your content and you’ve created the reference pack. What happens next?

An internal review step, and sometimes several internal reviews, will be carried out before any project leaves the agency.

Quality control is a massive deal for MedComms, and there are multiple layers to this. I’ve already mentioned data checking, and we also need to have a scientific and strategic review.

This might include a data check, but it’s usually coming at the data from a different angle. Not just looking at whether the specific data points in the content accurately reflect what was in the original paper, but also whether those data points are the right ones to choose from that paper, whether that paper is the right one to choose for the content, and if so, whether everything has been interpreted correctly with an appropriate context and the right level of detail.

This kind of review will normally be performed by the person who wrote the brief, and they’ll also look at big picture things like the storyflow and structure of the document, plus the more strategic side – whether it’s likely to achieve the objective for the audience.

They will then give their comments to the Medical Writer to update the project, and this is another important part of on-the-job training. This internal review step can be really hard for new Medical Writers. When you’ve utterly slaved over a project and you feel like you’ve done the best possible job, it can feel like a massive kick in the teeth to get it back absolutely covered in tracked changes.

The thing is, you don’t need to worry if this happens to you.

It’s completely normal and it’s how you learn to be a good medical writer. Medical writing is hard – it’s a really niche way of working, and there are so many different things to learn, but it’s really, really rewarding, so don’t let this put you off.

It’s impossible to pick everything up instantly and just get it right the first time, but that doesn’t mean that you are a bad writer or that you’re doing a bad job, or that you’re not suited to medical writing.

I know it’s easier said than done, but really try to find a way to see the comments that you get as something to look forward to, because they’re going to help you do a better job next time and develop as a writer in the long term.

So once you’ve taken in those comments, the person who briefed you may have more comments – and again, don’t worry, that’s not a bad thing, or it might be ready for the next stage of internal review – the edit.

Again, different agencies have different processes, but work is usually edited at specific points in the development process, often at the first and last draft stages.

This might be done by an in-house editor, maybe a freelance editor, or another member of the writing team, but it will normally include a copy-edit, making sure that the writing is as strong and succinct as possible, and maybe looking at the linguistic style considerations for that particular audience and content type.

The edit will often look at consistency too. So making sure that everything adheres to the style guide I mentioned earlier, and maybe other projects in that series or group, and also look at the visual elements, not just the words. Once the document has been edited, you might need to take in those editorial changes or simply check that you are happy with everything that’s been done.

And now we’ve reached the moment when your little project goes out into the big, wide world.

Depending on the kind of project that you are working on, the first external review step will usually be with the client. Most projects will be reviewed by specific people in the client team, and that might vary at different drafts.

Sometimes the first review will be with a small group or maybe even just your main client, but then they’ll want to get sign-off from a wider group at a later stage.

Sometimes the first draft will go to a big group so that lots of feedback and opinions can be gathered at that early stage, and then it would just need to be checked by a couple of key people as you get towards finalisation.

It will also happen in different ways too. Sometimes this external review with clients will be ‘offline’ – sent over by email, and then feedback sent in a reply.

This fairly low-key way of getting feedback is becoming less common though, and while it can be a useful way of getting comments quickly, It can also make it really hard to track who you’ve heard from, and you’re likely to get everyone’s feedback in a separate document, which obviously makes incorporating that feedback quite time-consuming.

A lot of projects will have to go via specific review systems like Veeva or Zinc, or Datavision for publications projects. These systems are used to collate feedback and provide an audit trail, and we often have to mark up the reference pack within them so that the client reviewers can do their own data check.

They can also be very useful for getting consolidated comments – everyone’s feedback in the same document, which is usually much easier to deal with than individual emails.

When we submit projects through these systems, they are sometimes then reviewed by a group of clients in a meeting, which is also great for making sure that any disagreements or conflicting comments are worked out before we get their feedback.

These systems are also used for approval of projects. Once all of the comments have been taken in, the project will be re-uploaded, and then the reviewers will go in and check that they’re happy with the final content and can approve it for use. This is usually necessary for any content that will be used outside the pharma company, and these systems could also be used as a repository for that approved content to make it really clear which version should be used.

But if we scroll back to the initial client review step, once we’ve had that feedback, we’ll need to incorporate their comments and then we come to the next external review step.

A lot of MedComms projects will include external experts, and depending on the project type, they may be involved as authors or speakers, or maybe advisors who are helping the pharma company with their expertise.

Their input is crucial – their expert insights guide the content development, and for some projects, particularly peer reviewed publications, they are ultimately responsible for it.

Getting feedback from external experts can be hard work. They’re normally practising clinicians, so their focus is their patients not providing comments for medical writing projects.

They’re busy, and we sometimes need to chase multiple times, maybe enlisting the help of their assistants or people from the client’s team in their country, to nudge them into providing the feedback that we need.

Because we do have to get that feedback in the end. If we don’t get any response from an author, we can’t submit a paper with their name in the author list. It’s a requirement for authors to provide input and approval for the paper.

If we don’t get their approval, we can’t submit their abstract to a congress. It’s crucial that we do everything that we can to get their feedback.

Another challenge around working with external experts is that they may have a very healthy ego, and this can have an impact on how they give feedback.

It can be blunt. It can come across as rude or condescending, though usually that’s not how it’s intended. There is sometimes a little bit of a language barrier or cultural differences that mean comments aren’t always received as they were intended.

But it does mean that as Medical Writers, we have to have a thick skin and look at the feedback that we get to find the essence of what they were trying to say, what they want the content to be, without being offended by how they actually said it.

After all, we’re all playing for the same team and we all have the same aim – that the project will be the best it could possibly be, and that it will help solve a problem for patients and improve outcomes for them.