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Medical writing is a fast developing discipline, which involves writing on topics useful for the medical fraternity and drug development. In the pharmaceutical industry, medical writers work in two broad areas: regulatory writing and marketing material writing.
Regulatory writing is an integral part of drug development and the approval process. It includes writing:
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………
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 marketing area, writers produce documents that advertise drugs and explain their benefits to physicians, pharmacists and consumers. A lot of literature needs to be developed to support the product and issues unique to the company keeping in mind the local and international regulatory guidelines. There is a growing need for health care information and appropriate compilation of product literature is expected to result in an increased consumer interest in the brand as well as the organization.
This has the implication that the medical writers should have an adequate knowledge of regulatory guidelines. They need to keep themselves updated in their related specialties. For the success of their projects, they should be able to produce documents that are of high quality not only in scientific content but also in terms of the organization, clarity, accuracy, format, and consistency and must adhere to the regulatory guidelines as well as company guidelines/styles/ processes. Organization of activities in medical writing in order to meet the project timelines is another challenging function.
Medical Writing: An expanding market
Medical writing services are gaining momentum as sponsor companies look for faster and more efficient ways to bring new drugs to the market. With regulations becoming more stringent, appropriate documentation of the safety and efficacy of new molecules is becoming increasingly important.
As the market for health care products is growing, the demand for health care information is also increasing and consumers, patients as well as physicians, demand more information regarding products.
Thus, effective medical writing is crucial both before a drug gets regulatory approval as well as during the marketing stage. As long as the drug development pipelines are full or increasing, medical writers will continue to play an expanded role in pulling together and writing regulatory submissions.
Why Outsourcing?
Pharmaceutical companies are now opting to outsource 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 increases the speed of work. The demand for high quality documents is also increasing as the difference between poor-quality and high-quality medical writing can mean the difference between a speedy drug submission and approval, and a rejection.
Although the pace of drug development is constantly increasing, most individual companies do not have many regulatory submissions and reports. For the companies that have an occasional regulatory submission, maintaining a medical writing team is challenging and can be a drain on resources. More companies are opting to outsource medical writing so that they can obtain quality services in a cost effective manner.
High mobilization rate in the pharmaceutical industry poses a big challenge to the development and maintenance of a medical writing department in huge pharmaceutical companies. Further, the bulk of medical writing tends to be piled towards the beginning or the end of the clinical studies, whereas in between medical writing department tends to have idle staff waiting for work. Company-employed medical writers have a propensity to share insular views that companies have regarding their own products. On the other hand, by outsourcing, these companies get an added advantage of the range of experience and unbiased attitude that freelance writers can provide.
Outsourcing medical writing to India
Globally, 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.
India has a pool of qualified, talented and experienced medical scientists. India, each year, produces approximately three million graduates, 700,000 post-graduates and 1500 PhDs in the scientific stream. This includes around 18,000 medical graduates passing out from 200 medical schools. Many Indian professionals have thorough knowledge of good clinical practices, drug development, experience with basic and clinical sciences and good writing skills. Many of them also possess industry experience and consequently know how to put together reports and analyze safety data.
Further, English is the primary language of these professionals and 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 biopharma 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.
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