The areas of medical writing work and how they compare

Medical writing covers regulatory, scientific, educational and promotional work. Its areas differ in their audiences, documents, purposes and working patterns, while sharing writing, editing and project-management skills.

The main areas and their boundaries

Medical writing produces scientific and medical documentation through a specialised writer who typically did not perform the research being described. ^{1, 2} Regulatory writing and medical communications are two broad categories of the work. ^{1, 3, 4} Regulatory writing serves clinical trial personnel, investigators, pharmaceutical companies and regulatory authorities; medical communications serves healthcare professionals, academic researchers and patients. ⁵

Regulatory writing includes the following document types. ⁶

• Study protocols and investigator brochures; clinical study reports and patient narratives.
• Periodic safety update reports, development safety update reports, periodic benefit–risk evaluation reports and risk management plans.
• Common Technical Document modules and summaries for regulatory submission.
• Toxicology reports; product labels, summaries of product characteristics and patient information leaflets.
• Responses to regulatory queries.

⁶

Medical communications includes the following document types. ⁷

• Original manuscripts, reviews, systematic reviews, case reports and case series, abstracts and editorials.
• Conference abstracts and posters; book chapters; consensus statements.
• Guideline development and updates for therapeutic areas.
• Web content for healthcare professionals and patients.
• Continuing medical education for physicians, advisory board meetings, conference proceedings and slide kits for clinical meetings.
• Training modules for sales representatives; medico-marketing literature such as leave-behinds, visual aids, compact discs and drug monographs.
• Health-related newspaper articles, health magazines and white papers.

⁷

The range also forms a spectrum from regulatory medical writing toward medical communications. ^{8, 9}

1. Regulatory submission summaries, including study reports, periodic safety update reports, protocols and investigator brochures.
2. Case narratives.
3. Answers to regulatory enquiries.
4. Regulatory support for marketed products, including value dossiers, patient information leaflets and summaries of product characteristics.
5. Peer-reviewed manuscripts, including systematic reviews.
6. Conference abstracts and posters.
7. Book chapters.
8. Teaching materials for physicians and other specialists.
9. Newsletters.
10. Medical journalism.
11. Slide kits.
12. Websites.
13. General teaching materials.
14. Patient materials.
15. Public relations and brand development.

^{8, 9}

The boundaries overlap: both medical communications agencies and companies focused on regulatory writing may prepare manuscripts. ¹⁰ A document should be well written and fit for purpose, whoever writes it. ¹⁰

One working distinction uses science writing for explaining science to the public, scientific writing for explaining it to experts, and medical writing for work focused on medicine. ¹¹ These labels overlap, particularly in translational research; a writer covering medicine and other sciences can describe the work as both scientific and medical writing. ^{11, 12}

Established careers can include regulatory, device, communications, education and safety writing, freelance work and moves into training, development and management; experience can lead to new directions without a linear career endpoint. ^{13, 14, 15}

Activities beyond writing

Medical writers may also translate into their native language, edit and proofread other people's documents, perform quality control and give training courses. ^{16, 17, 18} Quality control includes checking that the data quoted in a document are correct. ¹⁷ These activities also have specialists of their own: medical translators, for example, may have university training specifically in translation, while writers may be asked to help with related work. ¹⁸ Some professionals work specifically as medical or scientific editors, but editing skills also matter for writers, translators and communicators. ¹⁹

The roles can encompass scientist, data interpreter, project manager, writer, editor and diplomat. ²⁰ Project management is common to publications, regulatory writing and continuing medical education (CME), including managing large, changeable projects with many participants. ²¹

Differences in the working day

Publications work requires flexibility in working with authors ranging from clinicians to statisticians. ²¹ Regulatory work can offer the satisfaction of working with data and performing analyses, although producing standardised, concise text can be a drawback. ²¹ CME can offer varied projects and some creativity, alongside too little time for writing and editing, limited input into content, an intense pace and frequent travel. ²¹

A comparison by three practitioners in 2009 placed the greatest need for scientific expertise in regulatory writing, followed by clinical trial publications and then CME; all three nevertheless considered a basic understanding of medicine and related science essential. ^{21, 22}

A medical education role can combine a physician's biography for a speakers bureau, editorial planning for an advisory board meeting and an interactive case study for physicians. ²³ A research-team writing role can combine community health website materials with research on local health resources, community outreach, meeting coordination and minutes. ²⁴

Continuing education, regulatory writing and medical communications

Continuing medical education and continuing education (CE) combine scientific expertise with instructional design. ^{25, 26} The three areas can be compared across audience, deliverables, objectives, competencies and funding. ²⁶

Aspect	CME/CE writing	Regulatory writing	Medical communications
Main audience	Clinicians and healthcare professionals	Regulators and authorities	Researchers, public and healthcare professionals
Typical deliverables	Learning modules and webinars	Submission dossiers	Articles and promotional material
Core objective	Education and practice change	Compliance and approval	Information and awareness
Key competencies	Instructional design	Regulatory expertise	Flexibility and clarity
Funding sources	Mixed: sponsor and academic	Industry and sponsor	Mixed and industry

²⁶

Movement between areas

Experience with clinical or health economic manuscripts provides a strong background for understanding and writing about clinical, quality-of-life and outcomes data in payer documents. ²⁷ Regulatory and payer writing share skills in analysing and synthesising complex clinical data, managing review and approval, collaborating with teams and understanding drug development. ²⁸ Skills gained in publications or regulatory writing can therefore support a move into payer deliverables. ²⁹

Practitioners differ on movement between regulatory writing and medical communications. ^{30, 31} In 2015, one freelance education and sales-training writer saw regulatory writing as separate from an overlapping group of promotional, CME and other work, with no crossover between the two groups. ³⁰ Another writer encountered employers' hesitation about a lack of medical communications experience after a regulatory career, but subsequently obtained more communications work than regulatory work as a freelancer. ³¹ Association workshops helped that writer approach unfamiliar document types confidently, while the variety developed creative skills and supported growth as a writer. ^{31, 32}