Coordinating the experts who supply the content
A regulatory document is assembled from the input of many specialists, and the writer has to get that input, reconcile it where the contributors disagree, and keep them talking to each other as well as to the draft.
The contributors and their roles
Many different experts provide content within a regulatory document, and coordinating their input is challenging, which is why the document needs someone to orchestrate it. These experts are the usual stakeholders in a mid-sized or large pharmaceutical company, and depending on the size of the company some of their roles may be combined.
A regulatory writer in a pharmaceutical company works in large interdisciplinary teams and may work with clinicians, statisticians, study managers, pharmacologists, pharmacovigilance experts, quality-of-life experts, data managers and others, in a clinical team sometimes of 15 or 20 members. These people work in different functions, and the writer needs their input to write a document, so the writer is not writing alone but coordinating with many people. This work also gives the medical writer an opportunity to do some project management.
Medics in industry hold very different roles in clinical development. A clinical programme leader designs and manages studies, meets key opinion leaders, develops strategies for new studies, new drugs and new indications, leads the clinical team as its go-to person, and leads the regulatory submission for marketing approval. Clinical programme leaders are also quite often responsible for presenting the published data at international conferences. A pharmacovigilance physician monitors and investigates the cases of side effects during the clinical studies, is the in-house expert on the safety profile of a new product in development, and writes or contributes to safety reports for the health authorities. Medics in medical affairs communicate about new treatments between the sponsor and the medical community at large, and with the public, and collaborate on drafting marketing communications for new products.
The writer as coordinator
The writer is a team coordinator and a communication facilitator. Experts who need to align should reach out to each other and communicate separately, but in one regulatory writer's experience many do not, so the writer does a lot of handholding: for the document to be final by the deadline, the writer sets up teleconferences for them, attends, and makes sure they discuss everything they need to discuss. In the end the writer leads the team, facilitating cross-functional alignment when new topics come up and pushing the experts to make a decision. So the writer needs to know who the experts are and what each is responsible for, and sends a question by email not to all of them but only to the one who has to make the decision or provide the information.
Communication channels and stakeholders
How to communicate depends on what the writer wants to address and also on the person: some experts ignore emails and have to be pursued by chat, and some ignore chat as well and need a scheduled call before they answer. So communication is a lot about psychology. Beyond the experts providing the content, the writer keeps the submission team, who send the document out, aware of when it is coming and of any delay, and communicates with upstream stakeholders who can affect the document and downstream stakeholders whom it affects.
Other medical writers who have worked with the same client know something more about its expectations, information that may not be found in an SOP, and, where they know the team, can say how to handle the different stakeholders.
Disagreement and pressure
In one lead regulatory writer's account, a large part of the role is communicating, in writing, the content, expertise, perspectives and opinions of multiple contributors, who do not always agree. The writer cannot please everybody all of the time, and knowing where to give, where not to give, and where and how to compromise, all while maintaining positive professional relationships, is essential but sometimes challenging. A biostatistician colleague told that writer she would not want the job because it required "making everybody happy", whereas she felt her own work, statistical analyses, was much more straightforward.
Time pressure is a negative side of regulatory writing: all of the documents have to be written on time, and the general time pressure reflects pharmaceutical companies' wish to get to market as soon as possible. Dealing with difficult people and with criticism is another, since even the nicest people can become difficult under pressure. Keeping a very professional, calm pace throughout is very important for the medical writer.
Review cycles
Management of review cycles is an essential component of being an excellent regulatory writer. Most regulatory documents necessarily follow a process of design by committee: many different departments within a pharmaceutical company, and different levels of management within a department, might have a stake in one document, and reviewers may often have different goals and different priorities. With input from so many sources, review cycles can become chaotic, with the result that the final document lacks coherence and vision. A skilful and experienced writer should aim to come out of the review rounds with a document that is both readable and well structured while also representing the positions and opinions of the different contributors.
The importance of effective review rounds is easy to recognise, but in practice they are harder to achieve, and there is no right way and no magic formula. What works for one writer might not work for another, and an approach that succeeded for a writer on a past project might not work on the current one, because the project and the team differ.
For one lead regulatory writer, reviewers who review outside the company's document management system create extra work: comparing versions of the document, copying and pasting reviewer comments and tracked changes into the current version, and following up with other reviewers about what one reviewer said in their own version. Some people have to review outside the system, for example because they have no access to it while travelling, and that writer can be flexible about it but prefers to use the available technology where possible to automate such a tedious task.
Engaging the team
It is important to foster goodwill within the team, and many different details can help to win the team over and build a rapport. Where responsibility for a relatively trivial task is not clear, the writer can show willing, in contrast to those who refuse to budge a millimetre from their job remit. Over-willingness has its own dangers, as the writer may begin to get lumbered with tasks that should be nothing to do with them, and the time spent may not be billable for a freelancer, or a line manager may consider it wasted for an employee. The gains in goodwill, however, can be great, and they are difficult to quantify.
For a long time protocol development was somewhat transactional: a draft was developed and sent to the team for review, the team sent it back, and a new draft was developed. By 2025, teams no longer responded to that method as they used to and preferred more active engagement on a routine basis. Teams by and large favoured co-development, in which the writer works with the team, sometimes daily, to shepherd it through the process, over the traditional transactional approach.
Three pieces of feedback from protocol teams on their writers show proactivity, working with the team and co-development. In one, the writer added value to meetings by being proactive and offering solutions and expertise that guided the team and moved conversations towards better solutions. In another, the writer communicated upfront on timelines and tasks and arranged meetings when issues needed to be clarified, instead of just writing "what do you think" and awaiting a review, which made the process smooth and the collaboration good. In the third, the writer sent protocol questions during the drafting rather than waiting for the meetings, which saved a lot of time and allowed necessary changes to the protocol before the review meetings.
Getting engagement from clients and assigned functional leads can be difficult, and building that engagement during the early stages helps. To get it, the writer has to humanise the interaction and get to know the team. One way is to hold smaller pre-kickoff meetings besides the kickoff meeting, and regular touch points with key team members throughout the drafting of the protocol, for example with the project leader as the point of contact. Depending on the timeframe and on how mature the outline or design is before the drafting starts, a touch point may be held once a week, once every two weeks or even twice a week. A touch point gives an update on what is happening, what the writer has and what the writer needs, for example that the protocol is progressing and on track for delivery of draft one, that person X and person Y were emailed about topics X and Y and have not replied, and that a reply within two days would let their input go into draft one. A quick call of just 15 minutes in the morning can help humanise the process.
Other ways to support the team during the process are frequent updates with project leaders, regular breakout sessions to address specific comments, preparing for team discussions by sharing an agenda and a list of questions ahead of meetings, and digestible summaries of protocol progress and outstanding issues. One protocol writer has seen such summaries be quite effective in focusing team members, in the sea of emails they receive, on what the writer has, what is being done and what is needed. Being flexible is part of the support, within reason: a significant change to a draft requested by tomorrow morning, with the tracked changes arriving at the end of business today, is probably not going to happen. Informing the team of that helps them understand what the writer needs in order to provide a high-quality draft of a protocol.