Fundamentals of Good Medical writing

Being a successful medical writer requires an understanding of the drug development process, a strong grasp of scientific principles, and the ability to write clearly and effectively. Medical writing involves writing scientific 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. 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. 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.

Medical writing has its own standard practices and idiosyncrasies. Knowing what to write, how to format, and how to navigate corporate processes can require a big learning curve.

Types of Medical writing

Medical writing involves writing different types of documents for different purposes, and for different audiences. Following are examples of different kinds of medical writing,

1. Medical Journalism
2. Medical Education
3. Medical marketing of healthcare products
4. Publication/Presentation
5. Research Documents
6. Regulatory Documents

Each of the above 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 language used and the level of technical information has to be appropriate to the level of understanding of the respective audience. Get knowledge and develop skills from one of the best, ISO certified institute for imparting training and certification in Medical Writing.

Requirements for becoming a Medical Writer

The basic pre-requisite for becoming a medical writer is of course, familiarity with medical concepts and terminology. An academic qualification in one of the life sciences such as medicine, or paramedical sciences such as pharmacy, microbiology, nutrition and dietetics, biochemistry, biotechnology can provide the right background which makes the writer familiar with scientific concepts and research data.

Another important pre-requisite is the ability to write. As the basic requirement on the part of a medical writer is to communicate scientific information to the target audience, some degree of command over the language, reflected by an ability to write grammatically correct text, and an ability to express and present information clearly and succinctly is most important.

In addition to the above basic requirements, one needs domain knowledge & language skills.

Domain knowledge

Medical & therapeutic area knowledge – since the medical writer communicates scientific information related to the medical field, it is needless to say that he/she understands medical terminology and concepts. Writing technical documents related to specific therapeutic area e.g. cardiology or neurology, can be greatly facilitated by knowledge in that filed.

However, since medical writers seldom work in a single therapeutic area, it may not be possible for one to have a prior thorough knowledge of each therapy area. It would be a good strategy to have basic knowledge of different medical specialties, and build upon that as one goes on writing documents in different therapy areas.

Drug development process , pharmacology, drug safety – medical writers involved in the preparation of clinical research and regulatory documents such as trial protocols, investigator brochures, clinical study reports of different phases (I-IV) of clinical trials, efficacy and safety summaries require a thorough understanding of the drug development process, the clinical research and various guidelines related to these. Those writing reports of early clinical development also require a good grounding in pharmacology and an understanding of pharmacokinetic concepts. Similarly, medical writers writing safety reports need to understand the drug safety process and requirements of safety reporting prescribed by different regulatory authorities.

Statistics – Medical writers come across statistics when they write about clinical trials and when they write about research studies. The statistical results of clinical research must be communicated in a manner that allows clinicians to assess critically the quality and reliability of both the study design and any conclusions that might affect clinical practice. Every medical writer has to deal with confidence intervals, regression analyses, randomization schemes, P values, and t-tests. An understanding of statistics is necessary for good medical writing. One of the ways of developing this is attending workshops on medical statistics conducted by professional statisticians.

Technical guidelines – EU, USA and Japan have evolved a set of common guidelines (International Conference on Harmonization [ICH] guidelines) related to drug development and registration. In addition, the national regulatory authorities have their own specific requirements. Numerous guidelines are available on how to write clinical study reports (ICH E3), investigator′s brochures, patient information leaflets, clinical overviews, periodic safety reports (ICH E2C) and other documents required for regulatory submission. These instructions require thorough reading. Information about these technical requirements is usually available on the ICH website or websites of the Regulatory Authorities. Knowledge of these guidelines is a “must” for a regulatory medical writer. Moreover, new guidelines emerge, old ones are revised, and a medical writer has to keep up to date. Publication guidelines like Good Publication Practices, guidelines for reporting clinical trials (e.g. CONSORT), the International Committee of Medical Journal Editors' (ICMJE) guidelines for manuscripts are available. In addition, all medical journals have their own instructions for authors.

General Knowledge and Skills

Language & grammar – a medical writer has to communicate scientific information. In addition to understanding the scientific aspects, the writer needs to present the information in a clear manner and at a level of understanding appropriate to the target audience. Use of grammatically correct language, simple and short sentences, active voice, appropriate punctuation marks, and a logical flow of ideas can go a long way in making the information understandable to the readers. Avoiding the use of highly complex technical jargon also makes the writing more lucid, especially for nonmedical audiences.

Literature / reference searching – huge amount of scientific information is now available in the public domain. In addition to the books and medical journals, databases like Medline, PubMed, EMBASE, and Micromedex are commonly used for sourcing medical information. Searching through all medical databases and healthcare websites for information relevant to your purpose is like searching for a proverbial needle in the haystack. Keeping in mind what exactly you are looking for, knowing where to search and selecting only the authentic sources, planning your search strategy, use of correct keywords for searching and then carrying out the search as per the set plan is more likely to bring up useful information. Reviewing your search results to consider if the information is relevant and systematically classifying and filing useful information for later retrieval is equally important.

Interpretation and presentation of research data – writing scientific documents involves review and interpretation of research data, presentation of those data in text, tables, and graphs, and developing logical discussion and conclusions as to what the data means. Medical writers must have sufficient knowledge of the research topic, and should be able to understand the research design and data so as to interpret and present it to their readers. Presenting data in the form of tables and graphs is a skill which needs conscious efforts to develop.

Ethical & legal issues – issues of concern to medical writers are – giving 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.

So, what makes a good medical writer? The following qualities distinguish a good medical writer from a mediocre one:

• Ability to understand the purpose and requirements of the project
• Ability to write at a level appropriate to the target audience
• Thorough research of the subject
• Ability to think, logical organization of thoughts and ideas
• Scientific accuracy
• Attention to details
• Ability to work across teams (often remotely) as well as independently
• Good communication & coordination with various people involved in the process
• Good time management, and meeting deadlines and commitments

Training and Certification in Medical Writing

To fulfill the above required pre-requisites is a tough job. One can acquire the skills needed to become a good medical writer by obtaining training from a well-established ISO certified institute and become certified professional in Medical writing.

If you had a certificate of expertise in Medical Writing, then you would not have to go through the trouble of showcasing your skills to every person. All you have to do is take out your certificate of expertise and show it to them. The importance of certifications starts right from the academic journey in the initial stages. You get certificates as proof of completing your school education, high school, college, and university education.

Furthermore, certificates help you find jobs with employers you want to work for or showcasing your abilities. Even if all these benefits of certification are generalized, let us take a look at reasons for the importance of certification. The following discussion outlines different pointers that describe how certifications are beneficial.

• Certifications help job seekers stand out to hiring managers.
• Job retention increases when the organization invests in employees.
• Certification makes it easier to build a case for promotions.
• Grow your professional credibility and it subject matter expertise.
• Get recognized as an expert in new and current technologies.
• Meet professional or corporate requirements.

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