Anuradha MarlaMedical Writing is the art of presenting scientific data in a clear and concise manner, to a range of audiences and in a variety for formats. The target audience might range from consumers, who buy goods such as medicines and home use medical devices; to pharmaceutical companies that carry out research on a potential drug; and healthcare educational institutes imparting knowledge about diseases, drugs, biomedical devices etc. Medical Writing can be classified into two main broad areas, viz. regulatory writing and commercial writing. Regulatory writing outlines everything right from the trial procedure to documentation of results. Regulatory documents are generally huge eg: Protocol, Clinical Study Report, Informed Consent Forms, Investigator's Brochure etc.
These documents play a very important role in the approval of drugs and devices, thus having a direct influence on their entering the market. Poor quality documentation would lead to more trials, data collection/analysis, and repeated submission of documents to regulatory authorities. There is also a possibility of withdrawal of the trial leading to significant financial loss. Commercial writing, on the other hand, is more about advertising the drug for pharmaceutical or consumer purposes. It also includes writing manuscripts for publications, white papers, product monographs, editorial, original articles, review articles, personal views etc.
The qualities of an ace medical writer include but are not limited to the following:
- Good communication skills
- Ability to present data effectively and in a clear, concise manner
- Attention to detail
- Capability of working independently as well as in a team
- Ability to work under pressure and meet stringent deadlines
- Quick learning ability