Friday, 3 June 2016

Medical writing services: Delivering medical information to general public, physicians or regulators

Medical writing has become established as an important function in the healthcare industry, since it requires specialized knowledge and skills to be able to write scientific documents in a clear and lucid manner. It is the discipline of writing documents of different types which include regulatory and research-related documents, 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. Medical writing takes shape of books, chapters, abstracts, grant applications, patient case report and journal articles (manuscript). 

Different types of medical writing is meant for a distinct set of audience, e.g. medical professionals, patients & general public, medical sales representatives or drug regulators. Hence, the presentation of documents, language and the level of technical information has to be in accordance with the understanding of the respective audience. In addition, documents for regulatory submission are required to fulfil set formats and structures, and their contents are guided by regulatory rules and guidelines. 

The basic pre-requisite for becoming a medical writer is familiarity with medical concepts and terminology and ability to write. A competent medical writer should have good understanding of scientific, pharmaceutical and medical terminologies, command over english language and grammar, modern literature survey tools, presentation, methods of research data, publishing, reviewing, and editing requirements. In addition to the basic requirements, one needs domain knowledge, technical guidelines used for regulatory submission, basic skills in statistics and medical & therapeutic area knowledge for reproducing high quality document. A medical writer involved in the preparation of these documents needs to be conversant with the regulations and prescribed formats for such type of documents. Ethical & legal issues should also take into account to give truthful and complete information including negative findings, following copyright laws, not indulging in plagiarism, following authorship criteria for research manuscripts, and respecting journal review process
Medial writers mostly work with the pharmaceutical industry. However, there are many other setting in which medical writers are required viz. pharmaceutical/healthcare product companies including medical device companies, contract research organizations (CROs) & business/knowledge process outsourcing companies (BPOs/ KPOs), Scientific content and healthcare communication companies, media & publishing companies and medical journals academic medical institutions, medical/scientific societies and healthcare websites.
Recently a new medical writing field has evolved as Pharmacovigilance (PV) medical writing. This new field is not limited to only preparation of Periodic safety update report (PSUR) in the post marketing phase of products life cycle. In fact PV medical writing impacts on the clinical development and post marketing phases as well as making a relevant contribution to submitted documents required before the regulatory authorities for grant of marketing authorization. Recently in a survey, medical writing is ranked fourth most frequently outsourced service. The demand for medical writing is growing steadily over the years. The pharmaceutical and healthcare industry offers number of job opportunities for medical writers. Graduates and post-graduates in life sciences who have the right skills and aptitude can consider taking up medical writing as a full-time profession.

We at WorkSure® are committed to deliver authentic medical writing services to our clients with proof-reading, medical editing and  medical knowledge support.