Nonclinical regulatory writing as a specialism
Nonclinical regulatory writing combines a broad grounding in biological science with the ability to work with scientific experts across nonclinical development. Entering the specialism calls for scientific understanding, regulatory knowledge and skills in writing, editing and managing documents.
A developing role
Dedicated nonclinical writing historically remained a niche profession because scientists conducted studies and prepared much of the regulatory documentation themselves. In 2017, nonclinical writers reported growing demand for expert writing support as drug development and regulatory requirements became more complex, and expected that demand to continue increasing. They also reported scarce dedicated resources for nonclinical writers and little guidance on regulatory writing in nonclinical health authority guidelines.
In May 2024, one nonclinical writing practitioner described an industry trend towards dedicated nonclinical writers because the work is specific and technical. In that practitioner's experience, most people drawn to the work had been scientists and subject-matter experts themselves; speaking the same language as their scientific counterparts made document development more effective, particularly when writers joined early. Another practitioner described separate specialist groups for clinical and nonclinical work in their company, with some cross-training between them.
Scientific background and routes in
A strong background in biological sciences, usually with practical research experience, is needed to understand the range of in vitro and in vivo assays involved in nonclinical development. Most nonclinical writers have a strong science background and, in many cases, science degrees. Former scientists in a particular nonclinical domain, most often toxicology, may move into regulatory writing to provide specialised report and summary writing services.
One experienced writer's route began with grants, meeting abstracts and journal articles during postdoctoral research, followed by a move from leading translational pharmacology laboratories to writing in pharmaceutical research and development. The work progressed from research technical reports and pharmacokinetic/pharmacodynamic reports to regulatory documents, including briefing documents, investigator's brochures, protocols, clinical study reports, clinical development plans, and nonclinical and clinical modules for investigational new drug and new drug applications.
Breadth and skills
The many testing domains and reports in nonclinical development mean that nonclinical writers in pharmaceutical companies take a generalist approach rather than specialising in a therapeutic area or document category as many clinical writers do. They work closely with scientific experts across domains, and in some companies may do more editing than writing. They need to keep up with scientific and technical advances in this innovative field.
The skills include knowledge of nonclinical and clinical pharmacology, pharmacokinetics and toxicology; technical skills in data analysis, synthesis, and lean, strategic writing; and soft skills in communication, attention to detail, patience and listening. Writers provide strategic support on content across the development lifecycle. They also contribute institutional knowledge across a portfolio, expertise in platforms, technologies, standard operating procedures and vendors, and editorial support. The work extends from preclinical development through post-marketing, with collaborators in nonclinical development, clinical pharmacology, biostatistics, scientific communications and global medical affairs.
Like other regulatory writers, nonclinical writers need to manage projects and dossiers, communicate with and mediate between collaborators, understand and follow regulatory guidelines, and learn on the job. Conflict resolution involves managing different opinions and backgrounds, while project management covers document development from planning to approval. Early engagement with subject-matter experts offers an opportunity to learn with the team; the writer does not need to know everything.
Working with scientific experts
Scientists who rarely prepare regulatory documents often need training in report writing, submission requirements and the differences from academic writing. They also expect nonclinical writers to advise on regulatory matters, either through liaison with the regulatory lead or information about best practices, so writers must keep up with official guidelines and current practice.
Understanding and discussing science can help a writer engage with experts such as pharmacologists, cross-check scientific accuracy, ask questions that clarify meaning, and suggest changes to experimental design and statistical analysis. Quickly absorbing complex concepts and data supports efficient summaries for regulatory documents and scientific publications. Writers typically own documents, provide experts with templates and guidance on content and, to some extent, regulatory requirements, and keep up with document automation platforms. Communicating complex content and distilling it into key messages, storyboards, nonclinical and clinical summaries, and plain language summaries also calls for soft skills.
In 2017, the introduction of SEND files in CTD Module 4 meant that writers assembling nonclinical packages could find themselves coordinating both study report preparation and SEND file delivery.