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.
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