The main requirement for a medical writer is to have expertise in medical terms and concepts. A post graduate degree in medical science like pharmacy, health and nutrition, genetics and biochemistry can offer a medical writer with the right type of knowledge and familiarity with medical research and concepts. Another major requirement is proficiency in writing as a medical writer has to communicate scientific data in a clear and understandable way to his clients.
Take a look at some of the domain knowledge that a clinical writer should know about:
1) Knowledge of Medical Subjects: The purpose of a medical writing service or a medical writer is to communicate scientific and medical data to the client in a way that is understandable, hence the writer must have thorough knowledge about the various concepts, terminologies and jargons used in that specific field of medicine. A person who needs to create a medical report in the subject of nephrology or cardiology can do so without much difficulty, if he has experience and knowledge of the field. However, most clinical report writers have diverse therapeutic and medical subjects to write on and as it is not possible to have thorough knowledge in all medical areas, it is generally advisable to at least have a basic knowledge. As the writer gains more and more experience, his knowledge on the various subjects will build up.
2) Knowledge of Drug Development Process: Often medical writing services have to create clinical research documents for hospitals and pharmaceutical companies. Clinical research documents include protocol writing, Investigators’ Brochures, Clinical Trial reports and drug efficacy and safety summaries, which require a thorough understanding of the drug development process, its clinical research and the numerous regulations associated with it. For such reports, a degree in pharmacology can help the medical writer go a long way.
3) Knowledge of Statistics and Inferences: Medical writers often have to deal with quantitative data analysis in clinical trials and research reports, which involve statistics. A medical writer needs to infer the results of the statistics in a way that allows doctors to easily analyze the quality and effectiveness of the study design as well as the conclusive results the research yields. A good way to get some understanding of medical statistics is to attend workshops and seminars conducted by qualified medical statisticians for just this purpose.
4) Knowledge of Medical Guidelines and Regulations: The European Union, Japan and the USA have created a set of guidelines related to drug registration and its research and development called the ICH (International Conference on Harmonization). Now a days a medical writer has access to numerous guidelines which can help him write investigators’ brochures, case report forms, informed consent forms and clinical trial reports and overviews. A lot of information about clinical research requirements can be found at ICH’s website which is necessary for a medical writing service provider to know. He also needs to keep himself up dated as regards to any new guidelines that are introduced and old guidelines that have been revised. All medical journals which publish written medical content also provide a list of requirements to medical writers who offer journal submission services to their clients.