Updated: Dec 19, 2022
Changing market dynamics, expiring patents, and depleted product pipelines are all exerting pressure on pharmaceutical companies to outsource non-core activities in an effort to control costs and enhance drug-development cycle time. One of these activities is medical writing—an area that, although not at the core of pharmaceutical operations, has become increasingly critical as regulatory agencies have adopted more elaborate review measures that requires substantial amounts of documentation.
Medical writing involves creating well-structured scientific documents that include clinical research documents, content for healthcare websites, health magazines, journals and news. The scientific information in these documents needs to be presented to suit the level of understanding of the target audience, namely, patients or general public, physicians or the regulators.
Prerequisites for a medical writer
Medical writers require an understanding of the medical concepts and terminology, knowledge of relevant guidelines as regards the structure and contents of specific documents, and good writing skills. They also need to be familiar with searching medical literature, understanding and
presenting research data, the document review process, and editing and publishing requirements. Many resources are now available for medical writers to get the required training in the science and art of medical writing, and upgrade their knowledge and skills on an ongoing basis.
The demand for medical writing is growing steadily in pharmaceutical and healthcare communication market. Medical writers can work independently or be employed as full time professionals. Life sciences graduates can consider medical writing as a valuable career option.
Classification of Medical Writing
Medical writing can be broadly classified into two types: Regulatory medical writing and Educational medical writing.
REGULATORY MEDICAL WRITING involves writing documents for regulatory agencies seeking approval for devices, drugs and biologics. This includes clinical trial data, regulatory submission documents, post approval documents, etc.
EDUCATIONAL MEDICAL WRITING is writing documents about devices, biologics and medicine, specifically for general studies.
Types of Medical Writing
MEDICAL JOURNALISM: Documents written under medical journalism are generally for public at large. Such documents generally consist of newspaper and magazine articles and are written in as simple language as possible.
MEDICAL EDUCATION: For physicians and other healthcare professionals, medical writers are generally involved in writing textbooks, preparing online study material, PowerPoint presentations, Continued Medical Education (CME) programs etc. For patients, medical writers are routinely involved in developing education material. This generally falls under medico-marketing writing in pharmaceutical companies.
MEDICAL MARKETING OF HEALTHCARE PRODUCTS: Medico-marketing writing comprises of a major chunk of total work that is assigned to medical writers working in pharmaceutical and biotechnology companies. Many medical communication companies also hire medical writers to handle medico-marketing work outsourced to them. Medico-marketing writing involves developing promotional and advertising material, training manuals, product monographs, web content for general public, online learning study material etc.
PUBLICATIONS & PRESENTATIONS: Writing abstracts, posters and presentations for presenting research results at conferences, seminars and other meetings is very common for medical writers. Medical writers also write and review and edit journal articles and manuscripts.
RESEARCH DOCUMENTS: Medical writers are a very important part of any new drug development team. They play a critical role in developing important research documents such as clinical trial protocols, informed consent forms, investigators brochures, clinical study reports, subject diaries etc.
REGULATORY DOCUMENTS: A strong regulatory writing is team is crucial for any pharmaceutical or biotechnology company. They are generally the same writers involved in medico-marketing writing as well. Regulatory medical writers write documents needed for regulatory submissions such as for marketing approval of new drugs or for approval to conduct new clinical trials. Such documents involve package inserts of drugs, subject narratives, Common Technical Document (CTD), safety update reports, annual reports etc.
Scope of Medical Writing
The demand for medical writing has gone up considerably in the last few years. The reasons are many – more research studies are being conducted today in the biomedical field; pharmaceutical companies are developing more new drugs and medical devices, and various scientific documents need to be generated for submission to regulatory authorities during their approval process; the number of biomedical journals has gone up considerably and many more scientific articles are now published than before; similarly, with the addition of a new and a powerful medium like the ‘internet’ a lot of medical information is generated as ‘web content’ for medical professionals as well as for the general public.
According to the Center Watch analysis the medical writing market has doubled in size in the last five years, increasing from an estimated $345 million in 2003 to $694 million in 2008. Moreover, according to a separate survey, medical writing is also the fourth most frequently outsourced service. As pharmaceutical companies outsource more and more work to Asia, Indian graduates can look at medical writing as a valuable career option, and develop knowledge and skills required to take this up as a full-time profession.
Who requires medical writers?
Medial writers mostly work with the pharmaceutical industry. However, there are many other setting in which medical writers are required:
· 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 (Functional Service Providers)
· Media & Publishing companies and Medical Journals Academic medical institutions, Medical/scientific societies
· Healthcare Websites
The scope for medical writers is therefore tremendous and growing. This is also a profession which one can practice either independently as a freelancer, or as an employee in an organization, depending on one's experience, level of expertise and liking. So, learning medical writing can be the beginning of a life-long profession.
Medical writing is both a science and an art. It requires an understanding in medical science and an aptitude for writing. In addition, a thorough knowledge of specific requirements for different types of medical documents, and keeping up to date with the relevant guidelines is a must. 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.