The regulatory writer's role on the document
A regulatory writer spends most of the job on work other than writing: working in whichever mode the client asks for, alongside a regulatory affairs function whose responsibilities run through a product's whole life, drafting to what the document and the sponsor demand, knowing the clinical research the document reports, contributing judgement on the content as well as prose, absorbing changes of plan, and leading a team the writer does not manage.
How much of the work is writing
Most of the time a regulatory writer is not writing the regulatory document but managing it, and sometimes spends up to 90% of the time managing the document development process.
Passive and active writers
One experienced writer divides the ways a regulatory writer works into two modes. A passive writer only writes: the information arrives, there is usually a single point of contact for questions, and the review usually goes through one person who manages everything. An active writer is part of the team, coordinates it, follows people up, and has a project-manager role alongside the writing. Which mode applies usually depends on what the client asks for.
A writer working in-house for a pharmaceutical company can be a passive writer, and a freelancer embedded in a pharmaceutical company's team can be an active one. That writer holds that writers should empower themselves as active writers, because the active role is one that AI will not be able to replace.
The regulatory affairs function
Regulatory affairs professionals are familiar with Good Manufacturing Practice, Good Laboratory Practice and Good Clinical Practice, and medical writers probably apply principles of good writing practice, but in 2013 there was no officially published or legally binding quality standard for regulatory affairs itself. So each regulatory affairs department or professional defines what Good Regulatory Practice means in its own environment. One definition, from the perspective of a global pharmaceutical company, has two parts: complying with legislation, internal and external standards and policies, and the scientific, ethical and administrative requirements; and fulfilling the responsibilities of a regulatory affairs professional. Legislation, standards and policies are usually well defined and easily accessible, but the responsibilities have to be correctly understood for Good Regulatory Practice to be implemented properly.
One of the professional's responsibilities, at least in a large research-and-development company, is to provide strategic and technical guidance throughout a product's life cycle, from the discovery of new molecules, through proposals for new development projects, to full development and marketing authorisation. Maintaining existing licences and developing existing products further is crucial to the company's sales over many years, until a product is eventually phased out and replaced by a newly discovered one. One core activity is monitoring trends and changes in the regulatory environment and tracking ever-changing legislation for its implications on product development and maintenance. Presentation matters as well: even the most scientifically complete study and the best results do not guarantee a marketing authorisation if the authority is unwilling to accept the way the data are presented. The professional compiles the relevant technical documents during development, ensures an appropriate presentation of registration documents at submission, ensures that submission timelines are met and that agency questions are answered within the deadlines. In doing so the professional seeks an optimal partnership with the agencies, so that registration procedures run smoothly and launch is timely.
Regulatory affairs is increasingly becoming an important interface with almost every discipline within a company, and is also becoming important in external functions. Regulatory affairs professionals are responsible for:
- reviewing study protocols and final reports generated by the organisation's research and development department, and possibly archiving them
- accompanying development of the active ingredient, the formulation and the analytics, as well as the preclinical and clinical development and finished-product manufacturing
- keeping contact with marketing for life-cycle management of existing products and development of new ones
- being an active member of relevant industry associations
Peter Lassoff's article "The Hub of the Wheel" compares regulatory affairs to the hub of a big wheel: not the group that says no to new ideas, as it might have been perceived in the past, but the one that makes things happen and keeps the wheel turning.
Handling these different roles requires continuous training and building up regulatory intelligence. Intelligence is often defined as the transformation of information into knowledge: information is everywhere, but knowledge is very specific to a task or role. That knowledge can be gained, for example, through focused training and the targeted development of skills such as medical writing, sensitive cross-cultural communication and negotiation. Such skills cannot be gained simply by attending training courses. Junior staff need to take an active part, ideally together with an experienced colleague, in negotiations, teleconferences and industry associations. This hands-on approach is the only way to practise communication skills, get to know people such as regulators in person, and learn from mistakes. Continuous communication is also very important, within the team, with colleagues from industry and directly with regulators. The department needs to build up the experience of new staff and effectively collect the know-how of experienced colleagues, and there should be a system to capture retrospectively the lessons of past experiences, good and bad, and of right and wrong decisions.
Good Regulatory Practice can then be described as a quality system of the department, in which professionals understand their role and work in an environment that allows regulatory intelligence to be captured. The fundamental aspects of any quality system are usually standardised work processes, detailed instructions and a customised infrastructure. Because Good Regulatory Practice is not a legal prerequisite, it can be dealt with in a more relaxed manner and tailored to the department's needs and the company's size, and the head of department can define its details, possibly together with the whole team on certain issues. Processes should be agreed, documented and adapted to the workflows and the organisational structure, interfaces between functions should be identified and the communication pathways at them organised, all systems should be verified as supporting the processes, and systems and processes should be reviewed periodically and amended where necessary. All personnel in the department need to understand their role and commit to their functions, and in a department that follows Good Regulatory Practice all regulatory activities should support the company strategy.
Implementing Good Regulatory Practice requires continuous training of the professionals, establishing standardised processes and generating regulatory intelligence. It aims to support the development and licensing of safe, effective, high-quality drugs while keeping an optimal balance between regulatory requirements, the anticipated target profile and time to market.
Drafting the document
Drafting a regulatory document involves analysing the source documents, and the writer should know the type of document being written. A writer who does not yet know it trains during the daily work, reading through the sponsor's own documents on how to write it. The draft must be regulatory compliant, although a regulatory affairs specialist also reviews that compliance. It must meet the sponsor's requirements, so the writer reads the sponsor's documents and training to know what is required. It must also be focused and targeted, which requires knowing who the audience is and what this particular document is for, and the writer should know the sponsor's strategic expectations.
A writer who came to regulatory work from an academic background, having majored in English, was surprised by two things. The first was how much of the job was copying and pasting: although instinctively worried about plagiarism, the writer found there is no need to reinvent the wheel with every new report, because the old report can be pasted in and its fields and numbers updated. The second was how ungrammatical some of the original documents were: they got the message across, but much of their standard wording could be difficult for an uninitiated reader to parse, and some of the material had been written by people without a strong grasp of English. In updating the reports, the writer inserted serial commas and hyphens where they were needed and clarified confusing language that, though seemingly acceptable to the industry, the writer did not want attached to their own name.
Knowledge of clinical research
The writer needs to understand where the document falls within the clinical development path, because one document may have strategic implications for another. Daily work also requires knowledge of clinical research: how a trial is actually conducted, and the stakeholders and vendors who make it work operationally. It requires knowledge of the ethical standards and regulations that govern a trial, at whose core is good clinical practice, and awareness in daily work of the importance of compliance.
Strategic input on the content
One experienced writer holds that the writer should go beyond writing and give strategic input on the content. The experts who provide the content each work in their own silo, while the writer is the only one who sees the whole document, and so can identify gaps. The writer should challenge content that seems wrong or in need of expanding, even though the experts have the last word, because the writer needs to own the document, and the aim is a high-quality document and a successful clinical trial.
Finding information and changes of plan
Finding information is a key quality of a regulatory writer: it is not presented on a silver plate, so the writer interrogates many people to get what is needed and connect the dots. The writer needs to be ready for changes of plan, because they will certainly come. This calls for good problem solving and a high degree of flexibility.
At the same time the writer needs the courage to push back sometimes, for the writer's own sanity and resources and the team's, and for a document ready on time and at high quality. A team that keeps changing content after it should be final will at some point introduce an error into the document.
Leading without a mandate
Within the team, the writer is the stakeholder manager, the document-writing expert and the project manager. The other stakeholders are not document-writing experts, so the writer trains and educates them on what is expected of them. As project manager, the writer keeps track of the timelines. In the end the writer leads without a mandate, shepherding the team towards a timely, high-quality submission and pushing them there, and can sometimes think of themselves as the mother or father of the team.