What is medical writing?
Medical writing is about writing primarily scientific documents describing e.g. research results, product use, disease or drug-related educational and promotional literature, publication articles like journal manuscripts and abstracts, content for healthcare websites, health-related magazines or news articles and other medical information. A medical writer is not involved in the research itself, but works with doctors, scientists, and other subject matter experts in presenting the information in an appropriate manner by creating documents that effectively and clearly describe the topic. Also, the medical writer ensures that the documents comply with regulatory, journal, or other guidelines in terms of content, format, and structure.
The need for medical writing in the pharmaceutical industry is increasing as companies develop more new drugs and medical devices, and various scientific documents need to be generated for submission to regulatory authorities during their approval process. Regulatory medical writing means creating the – huge - documentation that regulatory agencies require in the approval process for drugs, devices and biologics. All new drugs go through the increasingly complex process of clinical trials and regulatory procedures that lead to market approval. This demand for the clear articulation of medical science drives the demand for well written, standards-compliant documents that the regulators can easily and quickly navigate through (i.e. in Common Technical Document [CTD] format), read and understand. Medical writing as a function has become established especially in the pharmaceutical industry because the industry recognized that it requires special skill to produce well-structured documents that present information clearly and concisely.
A medical writer is often involved in the preparation of the following documents:
Research documents, e.g.:
- Clinical trial protocols
- Investigators′ Brochure
- Informed Consent Documents
- Study reports
- Research proposals
Regulatory Documents, e.g.:
- Summary of Product Characteristics & Patient Information Leaflets
- Clinical study reports
- Subject narratives
- Regulatory submission documents, e.g. Common Technical Document (CTD) modules such as nonclinical and clinical overviews & summaries, expert reports, safety and efficacy summaries
- Safety reports, e.g. Periodic Safety Update Reports (PSURs), bridging reports, periodic benefit-risk evaluation report (PBRER), Development Safety Update Report (DSUR), Risk Management Plans etc.
- Disclosure of clinical results on e.g. clinicaltrials.gov and EudraCT
The regulatory medical writer is not necessarily an expert on the scientific content of the documents, but understands science and the data sufficiently to interpret it correctly as well as have the ability to summarise the statistical findings. Further, the medical writer is skilled in producing well-structured documents that present information clearly and concisely and ensures that the documents comply with regulatory or other guidelines in terms of content, format, and structure.
Source: Perspect Clin Res. 2010 Jan-Mar; 1(1): 33–37. Suhasini Sharma: How to Become a Competent Medical Writer?