Regulatory medical writing professional#
James Lind Institute provides Advanced Post Graduate Diploma and Professional Diploma online courses in the field of medical writing and medical journalism to impart writing and analytical skills to its students.
Online courses in Scientific and Medical Writing at James Lind Institute There exists a huge demand for medical writers in pharmaceutical and biotechnology companies, contract research organizations, healthcare companies and media. They should be followed in order to consistently maintain the quality of publications. These guidelines act as an agenda for medical writers and employers who hire them. All relevant findings included in the publication from other related reports should be appropriately cited.The medical writer must ensure that the publications developed by them are scientifically valid and in line with the guidelines issued.The medical writer must be provided with access to the study data and study protocols before starting work on the publication.The contribution of medical writer and funding source should be acknowledged to ensure transparency and declare any potential conflicts of interest.The medical writer is a mere facilitator in developing the manuscript while the entire responsibility of the content is held by the named author(s).The named author(s) must be involved at the earliest possible stage and be responsible for all stages of the publication.Unless the writer has made a significant contribution towards the analysis and interpretation of data and be accountable to the research, he shouldn’t be given an authorship of the publication.In order to provide guidelines for the medical writers and outline their designated role in peer-reviewed publications, the European Medical Writers Association has developed a set of guidelines few of which can be briefed as follows: Before the document is made available for electronic publishing, it should be rigorously edited, proof-read, formatted as per requirements, checked for plagiarism and signed off. It is necessary for a medical writer to thoroughly understand the purpose of the project being taken up, conduct a brief search to collect related literature and then compile the document. Since each of these types of medical writing is intended to the respective set of audiences, appropriate language and style of writing have to be followed to serve the purpose. It may take many forms ranging from medical journalism, medical education, medical marketing of healthcare products, publication/presentation, research documents and regulatory documents. Medical writing involves communicating health and medicine related information in a clear and appropriate manner to the target audience.
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