Medical writing is the process of writing scientific or regulatory document by specialized writers known as the “medical writers”. Medical writers might not be the real scientists who did the authentic research, but work with the physicians / scientists concerned in the creation of data, and thereby assist to present that data in appropriate and clear way. The importance of good medical writing must not be ignored as science depends on clarity and accurate reporting, otherwise meticulous research can appear imperfect if poorly presented.
Medical writer provide services in various steps of drug development, it includes i) Discovery Phase : Medical writers contribute in Pre-clinical study reports, pre-clinical services of IND (Investigational New Drug), clinical services of IND (Investigational New Drug), clinical development plans, investigator brochure, exploratory protocols and CTD (Common Technical Document) Modules ii) Clinical Research: In this phase medical writers deal with Investigator Brochure Updates, Clinical Trial Protocol and Informed Consent Documents iii) Post-Marketing: They assist in preparation of Phase IV study documents, Periodic Safety Updates Reports(PSUR), abstract and poster, manuscripts, therapeutic training module Q&A booklets in Post marketing phase.
Medial writers hold high demand in the pharmaceutical industry. However, there are many other organizations in which medical writers play important role i.e. healthcare product industries including medical device organization, Contract research organizations and business/ knowledge firms outsourcing companies. Media & Publishing companies which produce scientific content.
The demand for medical writers is tremendously increasing. This is a career which one can opt either independently or on a contractual basis, or as an employee in an organization, depending on level of experience and interest. The basic requirement for becoming a medical writer is familiarity with medical concepts and terminology while academic qualification includes life sciences such as medicine, or paramedical sciences such as pharmacy, microbiology, biochemistry, biotechnology. A life science background enables the writer to comprehend scientific k and research data better.
The medical writer must have a clear understanding of the medical knowledge and facts, and should be able to present that data and its analysis in a manner that it will be understood by the particular community. Medical writing desires to fulfill the specific requirements for different types of documents. There are various steps that are followed during medical writing viz. Understanding the project brief, Literature search & review of information, Authoring & compiling the document, The review process, Formatting & editing, Approval and sign off, Electronic publishing.
Medical writers concerned with the preparation of clinical trials and regulatory documents such as clinical protocols, research brochures, clinical study data of I-IV phases of clinical trials, efficacy and safety data require a thorough understanding of the drug development process, They should have be aware of various guidelines related to trials. An understanding of statistics: confidence intervals, regression analyses, randomization schemes, P values, and t-tests is also necessary for good medical writing.
Thus, medical writing is both science and an art, which starts with deep understanding of medical knowledge besides having a flair for writing. A large number of scientific data and documents need to be prepared in the health care industry; hence there is an increasing demand for medical writing professionals. Therefore, it can be said that medical writers are building blocks of healthcare organization.
We at WorkSure® impart a structured on job training to our Medical Writers, so that they can read, understand and reproduce the documents across the therapy areas.