Medical writing is the activity of producing scientific and medical documentation by a specialized writer. Medical writing as a function became established in the pharmaceutical, medical device industry and Contract Research Organizations (CROs) because the industry recognized that it requires special skill to produce well-structured documents that present information clearly and concisely.
Medical writing is generally broken down into two categories. The first one is called medical communications and the second one is called regulatory writing.
Regulatory writing refers to the writing of documents that relate to the pharmaceutical of medical devices development process. These texts are used within the context of the regulatory process that a given drug or a medical device needs to fulfill with to be in the market.
Medical communications refers to writing documents with the objective of informing the public, be it a technical or a non-technical audience, about a given drug, a medical device or a condition.
What are the characteristics that distinguish a good medical writer?
Mainly,
- Ability to understand the purpose and requirements of the project
- Ability to write at a level appropriate to the target audience
- Thorough research of the subject
- Ability to think, logical organization of thoughts and ideas
- Scientific accuracy
- Attention to details
- Ability to work across teams (often remotely) as well as independently
- Good communication & coordination with various people involved in the process
- Good time management, and meeting deadlines and commitments (1)
Medical Writing training
In these courses, participants increase their practical skills in writing a medical text, the structure it needs to have, and how to appropriately review it. The courses on Medical Writing are designed for those who need to prepare documentation related to medicines or medical devices: from clinical research protocols to manuscripts or regulatory submissions.
Through our Medical Writing trainings, you may learn the skills needed to convey your key message to your reader with the appropriate form and format.
1.Sharma S. How to become a competent medical writer?. Perspect Clin Res. 2010;1(1):33-37.
What do medical writers do: the work behind every scientific document
A medical writer turns clinical, regulatory and scientific data into documents that are clear, accurate and compliant with industry standards. The scope is broad: regulatory dossiers, study protocols, articles for peer-reviewed journals, pharmacovigilance documents such as DSURs and PSURs, and scientific communication materials for conferences and the public.
Anyone asking what medical writers actually do should think of it as translation work: taking complex, often technical results and turning them into a readable text for the right audience, whether that's a regulatory reviewer, a scientific committee or a patient. Every document type has its own rules for structure, terminology and guidelines, from ICMJE recommendations for scientific publications to the standards required for medical device dossiers.
Healthcare writer: the skills that actually matter
A healthcare writer works at the crossing point between science and communication. It takes a solid grounding in clinical research methodology, the ability to read statistical data and turn it into a coherent text, and knowledge of industry guidelines, such as Good Publication Practice or the CONSORT and STROBE standards for scientific reporting.
On top of the technical side comes attention to language: clear sentences, logical structure, and the kind of detail that in a regulatory document or a study protocol can be the difference between an approved text and one sent back for revision. A growing part of daily work is also the critical use of AI tools, useful for speeding up parts of the process but requiring management in line with compliance rules such as the AI Act.
Medical writer career: where people work and how they grow
A medical writer career can develop across different settings: pharmaceutical companies, CROs, medical communications agencies, or independent contracting. Those working in regulatory affairs focus on dossiers and documents for authorities; those in scientific communication write articles, abstracts and conference materials; those in pharmacovigilance draft documents such as risk management plans.
Ongoing training is a core part of this path, since regulation, publication guidelines and digital tools keep changing. LS Academy's courses in this area cover the full path of a medical writer: from writing and reviewing technical texts, to building clinical study protocols, through to writing scientific articles for peer-reviewed journals and presenting data effectively at conferences.
Frequently asked questions
What do medical writers do day to day?
They write and review scientific and regulatory documents, such as study protocols, dossiers for authorities, scientific articles and pharmacovigilance documents, following the specific guidelines for each document type.
What is a healthcare writer?
A professional who combines scientific knowledge with writing skills to produce healthcare documents that are clear, accurate and compliant with regulations, aimed at different audiences: regulatory authorities, the scientific community or patients.
How do you build a medical writer career?
You can work at pharmaceutical companies, CROs, medical communications agencies or as an independent contractor, specialising in areas such as regulatory affairs, pharmacovigilance or scientific communication, with ongoing training on industry guidelines.
What training does a medical writer need?
A grounding in clinical research and statistical methodology, knowledge of scientific publication guidelines and hands-on practice writing regulatory documents. Specific courses help keep these skills up to date over time.