Global pharmaceutical companies are turning to India in order to tap the medical writing potentials of the country. A large number of qualified and experienced professionals, cost effectiveness, and wide use of English are some of the advantages that make India a dream destination for outsourcing medical writing.
Writing and editing on medical topics, whether for professional or general audiences, requires special knowledge and skills and familiarity with writing in American English & British English style guides – AMA style or Chicago manual style. Medical writing is a fast developing discipline, which involves writing on topics useful for the medical fraternity and drug development. The quality of documents submitted for regulatory approval plays a significant role in the success or failure of new products, inventions, and devices.
In the pharmaceutical industry, medical writers work in two broad areas: regulatory writing and marketing material writing.
Regulatory Writing Includes:
Protocols, Investigator’s brochures, Interim and final clinical study reports, Periodic safety update reports, Serious adverse event reporting, Investigational new drug applications, Common technical documents, Food and Drug Administration (FDA) briefing documents, Integrated summaries of efficacy and safety, manuscripts, Abstracts, Posters, Product labeling using terminologies, standardized by regulatory and international agencies And much more…
Marketing Material Writing Includes:
Writers produce documents that advertise drugs and explain their benefits to physicians, pharmacists, consumers, an appropriate compilation of product literature to result in an increased consumer interest in the brand as well as the organization etc.
Globally, Pharmaceutical companies are now opting to India in order to meet deadlines, maintain high quality and/ or reduce the cost; outsourcing to companies that have staff with medical background and technical knowledge of the regulations. The demands for high quality documents is increasing for a speedy drug submission and approval, and avoid a rejection from FDA.
India has a pool of qualified, talented, and experienced medical scientists. Many Indian professionals have thorough knowledge of good clinical practices, drug development, and experience with basic and clinical sciences and good writing skills with a blend of industry experience.
As English became more like a primary language of these professionals they can communicate and produce good quality, scientific documents just like their American and British counterparts. An interesting fact is that according to some estimates, 15% of the scientific population of Pharma and biotech companies in US is of Indian origin.
Further due to cost advantages and competitiveness, India is being considered as a destination for medical writing and other CRO services that are needed for the growth of the Bio pharma segment.
Indian professionals have already made their mark in Information Technology and Medical Tourism and now the world is looking at us to be a partner in Clinical Research and Medical Writing.