Medical writing entails the creation of various scientific documents, such as regulatory and research-related documents, disease- or drug-related educational and promotional literature, journal manuscripts and abstracts for publications, content for healthcare websites, articles for magazines or news stories, and publication articles, such as journal manuscripts. The scientific material in these publications must be presented to the intended audience, which may include patients or the general public, clinicians or regulators, at their level of competence. Medical writers must understand medical concepts and terminology, be aware with relevant guidelines about the structure and content of specific articles, and have great writing ability. They must also be competent about searching for medical literature, interpreting and presenting research results, the document review system, and editing and publishing requirements. Medical content writer nowadays has access to a wide range of resources that may assist them in completing the essential training in the science and art of medical writing as well as continually improving their knowledge and talents. Medical writing is in high demand in the pharmaceutical and healthcare communications industries. Medical writers might work as independent contractors or as full-time workers. Graduates in the biological sciences may desire to consider a career in medical writing.
As a consequence of an increasing corpus of research studies, increased clinical experience, and new ideas and concepts, the field of medicine is constantly accumulating new knowledge and information. All of this information must be communicated effectively to a variety of groups, including physicians and other healthcare professionals, patients and consumers, and drug regulators. Medical writing refers to the field of writing in which “medical writers” who work in the medical business create scientific papers. The medical content writer works alongside the physicians and scientists who create the data to portray the information in the best manner possible, even if they are not the original scientists who did the research. Because science is based on exact and unambiguous reporting, the importance of outstanding medical writing cannot be stressed. Even solid research might be tainted by poor presentation.
In order to give data and its interpretation in a way that the target audience would find intelligible, the medical writer must have a deep understanding of medical ideas and concepts. The medical content writer uses his grasp of research with their scientific competence to convey information at the right level for the intended audience. Furthermore, the writing must correspond to the specific criteria for the different types of publications. Medical writing has established itself as an important function in the pharmaceutical business due to the specific knowledge and talents required to generate scientific articles that are well-structured and presented in a clear and straightforward manner.
There has been a noteworthy growth in the demand for medical writing over the last several years. There are numerous reasons for this, including the fact that more biomedical research studies are being conducted today; pharmaceutical companies are producing more new drugs and medical devices; various scientific documents must be produced for submission to regulatory authorities during their approval process; the number of biomedical journals has increased significantly, and many more scientific articles are now published than previously; and similarly, with the addition of a new drug or medical device, the number of biomedical journals has increased significantly.
According to a CenterWatch research, the medical writing sector rose by more than half in the preceding five years, from an estimated $345 million in 2003 to $694 million in 2008. According to a separate survey, medical writing is the fourth most commonly outsourced service. As pharmaceutical companies send more and more of their work to Asia, Indian graduates should consider medical writing as a worthwhile career option and acquire the knowledge and skills required to pursue it as a full-time career.
Styles of Medical Writing
Writing for the medical business requires creating a number of articles for a variety of audiences and goals. The following are some samples of several forms of medical writing:
Newspaper and magazine articles. Because they are mainly meant for the general public and laypeople, they should be written in simple, straightforward language.
There are textbooks, CME programmes, presentation decks, and e-learning courses accessible for physicians.
Patients’ patient education materials
Healthcare item marketing in medicine
Promotional materials geared towards healthcare professionals, such as product monographs, brochures, and handouts
E-learning courses and sales force training manuals
Medical and patient (consumer) resources are available online.
- Journal research papers, case studies, and review articles
- Posters and presentations for scientific conferences and meetings
- Papers of Research
- clinical trial techniques
- Brochure for Detectives
- Informed Consent Records
- research findings
- Agendas for research
Package Inserts (Prescription Information) and Patient Information Leaflets
Clinical trial reports and online summaries
Common Technical Document (CTD) modules for regulatory submissions, such as nonclinical and clinical overviews and summaries, expert reports, safety and efficacy summaries, aggregate safety reports such as periodic safety update reports (PSURs), bridging reports, periodic adverse drug experience reports (PADER), annual safety reports (ASRs), and policy papers.
Each of the aforementioned types of medical writing is intended for a particular audience, such as medical professionals, patients, and members of the general public, as well as medical sales agents or drug regulators. As a consequence, the language used and the level of technical expertise required must be appropriate for the individual audience’s understanding. Documents meant for patients and the general public, on the other hand, must be simple and free of technical jargon, but those intended for medical specialists and regulators might be quite complicated, including scientific facts as well as their interpretation. Regulatory standards and guidelines also serve as a reference for the content of papers that must follow certain forms and structures in order to be submitted for regulatory assessment. As a consequence, a medical writer who works on these documents must be conversant with the regulations and forms that govern this kind of document.
As a result, the knowledge and talents required to write different types of medical papers are likely to vary, and a person may choose to specialise in a certain sort of medical writing depending on their aptitude and interests.
Who needs medical writers?
The majority of the time, media journalists work in the pharmaceutical industry. However, there are also more occasions when medical writers are required:
- Pharmaceutical and healthcare product producers, including medical device manufacturers
- Contract research organisations (CROs) and businesses that outsource business and knowledge processes (BPOs/KPOs)
- Companies that offer scientific information and healthcare communication (Functional Service Providers)
- Medical periodicals, media and publishing companies, academic medical institutions, and medical and scientific groups
- Websites devoted to medicine
As a result, there is a large and rising market for medical writers. Depending on one’s experience, level of competence, and preferences, one may do this profession as a freelancer or as an employee in an organisation. So studying medical writing might be the start of a lifelong profession.
Qualifications for a career as a medical writer
Knowing basic medical vocabulary and concepts is, of course, required for working as a medical writer. An academic degree in one of the life sciences, such as medicine, or paramedical sciences, such as pharmacy, microbiology, nutrition and dietetics, biochemistry, or biotechnology, may give the necessary foundation.
The ability to write is an essential need. The major job of a medical writer is to transmit scientific knowledge to the target audience, therefore language proficiency—expressed as the ability to produce grammatically correct text—as well as the ability to explain and present information clearly and succinctly—are required.
Along with the aforementioned core qualities, topic competence and language ability are required.
Knowledge of the medical and therapeutic sectors – It goes without saying that a medical writer is acquainted with medical language and concepts since they are used to communicate scientific facts about the medical profession. Expertise in a certain therapeutic specialty, such as cardiology or neurology, may make writing technical content on that topic much simpler.
Having an extensive knowledge of each therapeutic discipline may not be possible, however, since medical writers seldom specialise in a specific therapeutic area. Having a basic awareness of different medical specialisations is a sensible decision, and one may build on that information as they compose essays in other therapeutic professions.
Medical writers who work on 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, and more must have a thorough understanding of the processes involved in developing new drugs, conducting clinical research, and the various rules pertaining to these. Those who produce reports on early clinical development must also understand pharmacokinetic concepts and have a sound background in pharmacology. Similarly, medical writers who create safety reports must be aware with regulatory organisations’ criteria for safety reporting as well as medication safety procedures.
Statistics – Medical writers must depend on statistics when writing about clinical trials and research projects. Clinical researchers must communicate their statistical results in a manner that allows doctors to critically assess the validity and dependability of the study design as well as any conclusions that may have an influence on clinical practise. Every medical writer must deal with confidence intervals, regression analyses, randomization approaches, P values, and t-tests. Effective medical writing requires a strong understanding of numbers. Attending medical statistics seminars given by trained statisticians is one way to do this.
Technical guidelines – The European Union, the United States, and Japan produced the International Conference on Harmonisation [ICH] guidelines, which apply to drug research and registration. National regulatory organisations each have their own set of standards. Clinical research reports (ICH E3), investigator’s brochures, patient information booklets, clinical overviews, periodic safety reports (ICH E2C), and other regulatory submission documents may all be written according to a set of guidelines. It is critical to carefully read these instructions.
You may typically find information about these technology requirements on the ICH website or the websites of the Regulatory Authorities. These standards “must” be known to a regulated medical writer. A medical writer must also remain up to date since new guidelines are introduced and old ones are revised. There are publishing standards such as the International Committee of Medical Journal Editors’ (ICMJE) manuscript guidelines, Good publishing Practises, and clinical trial reporting standards (such as CONSORT). Furthermore, each medical magazine has its own set of writing rules.
In general, knowledge and abilities
A medical writer must use language and grammar to communicate scientific facts. In addition to understanding the scientific components, the writer must transmit the content to the desired audience in an intelligible manner. Clear language, short sentences, the active voice, proper punctuation, and a logical flow of ideas may all aid readers in understanding the information you’re attempting to express. When highly advanced technical language is omitted, writing becomes clearer, especially for non-medical readers.
Searching the literature or references: The general public today has access to a plethora of scientific information. Medical information is often obtained via databases such as Medline, PubMed, EMBASE, and Micromedex, as well as books and medical periodicals. Searching all medical databases and healthcare websites for information relevant to your requirements is like to seeking for a needle in a haystack. If you keep in mind exactly what you are searching for, know where to look, utilise only credible sources, structure your search strategy, use proper keywords, and then execute the search as intended, your search is more likely to bring up relevant information. It is critical to carefully pick and save useful data for later retrieval, as well as analyse your search results for relevancy.
The interpretation and presentation of research findings are critical components of writing scientific papers. These responsibilities include reviewing and evaluating research data, presenting it in text, tables, and graphs, and drawing logical conclusions based on the findings. Medical writers must have a solid awareness of the research topic, as well as the research approach and data, in order to assess and explain the study results to their readers. Data presentation using tables and graphs is a skill that takes careful practise.
Medical writers are concerned with ethical and legal issues like as providing accurate and thorough information, especially when the findings are negative, complying to copyright laws, avoiding plagiarism, following to authorship criteria for research papers, and respecting the journal review process.
So, what differentiates a good medical writer? A good medical writer has the following features that distinguish them from poor ones:
- Understanding of the project’s objectives and requirements
- Understanding how to write for the desired audience’s reading level
- comprehensive research on the subject
- Thinking abilities, logical cognition, and concept organisation
- precision in science
- Detail-oriented observation
- the ability to work both alone and in groups (usually remotely).
- Excellent teamwork and communication with all process participants.
- meeting duties and deadlines, as well as practising effective time management
Writing a Scientific Paper
Understanding the project brief is essential before starting to write since it will assist the medical writer understand what the sponsor expects to achieve with the article. It is also critical to be aware of the timeframes, data that must be checked, and assessment and approval processes.
The proper preparation and time spent on a literature search and review may give beneficial content for a medical writer to utilise to support the article they are writing. It is critical to utilise the proper search strategy and to structure the information you obtain into digestible chunks.
Writing and organising the document: The bulk of time is often spent on the first draughts. Building the draught requires knowledge on the kind of document, its role, and its contents. Using a pre-made template simplifies the procedure. Aside from the scientific component of the content, having appropriate language skills and following to the company’s or client’s style guide today will assist reduce the time required for subsequent review and editing. In addition to the primary material, the document may have a few appendices. These are often provided by the sponsor. However, the medical writer must ensure that the appendices included in the final version of the article are correct and up to date.
The contents of a document, as well as its editing and formatting components, must be reviewed as part of the review process for scientific articles. In most circumstances, a senior medical writer with more experience and a subject-matter specialist—who may be a physician or an expert in a certain therapeutic area—take on the former role. A quality check (QC) of the contents is also required, which comprises comparing all verifiable information to data from the sources. This is usually done by a peer medical writer. Before submitting a manuscript for additional assessment, every medical writer must do a thorough “self review” of the original draughts.
Writers must grasp formatting and editing abilities in order to make their text more attractive and accepted. Checking the uniformity of text font and size, line and paragraph spacing, headers and footers, margins and page numbers is part of formatting. Checking language, such as US or British English, typos, punctuation marks, right use of tense, and acceptable reference style are all part of editing. Documents that must be published or distributed electronically must go through a rigorous copy-editing, proofreading, and formatting check procedure.
All scientific documents need permission and signing from the designated approver, who is often an expert. The document must be provided enough time for the approver, who might be internal or external, to review and sign it.
Making information available in digital form for internet access is known as “electronic publishing,” and the ability to use a number of software tools currently available for e-publication may be required for modern medical writers.
Professional Medical Writer Training and Resources
There is no official degree, diploma, or certification course in medical writing. This kind of training often involves
Internal training: Companies that use medical content writer often gives suitable general and project-specific training to new staff. This might involve training in the drug development process, exposure to drug safety and medical statistics data, knowledge with different regulatory documents and their standards, as well as internal templates, work practises, and style guides.
Professional organisations may organise one- or two-day training sessions or workshops on a variety of topics, including. CSRs, protocol writing, statistics, and so forth.
On-the-job “mentor-guided” training is often offered by a senior medical content writer with more experience writing different sorts of publications. Training focuses on the specific sorts of documents handled by the organisation.
Motivational “self-study” is essential in the education of a medical writer. Writers who are self-motivated and curious may learn a lot about the many types of medical writing.
Medical writing is both a science and an art. It requires writing skills as well as understanding of medical science. Additionally, it is critical to learn and remain current with the requirements for different types of medical documentation. The need for medical content writer has grown over time. Medical writers might find work in the pharmaceutical and healthcare industries. Graduates and postgraduates in the life sciences with the requisite talents and skills may consider pursuing a full-time career in medical writing.