Medical writers analyze and interpret medical issues in order to present them as understandable and concise in publications such as health-related magazines, journal manuscripts, regulatory and research-related documents, disease, or drug-related educational and promotional literature. The scientific information in these documents is the science of communicating biomedical data to appropriate target audiences such as the regulators, health-care professionals, or patients and the general public to achieve certain objectives.
The medical writer needs to have a clear understanding of the medical concepts and terminology, knowledge of science, and their technical guidelines as regards the structure and contents of particular documents and satisfactory writing skills.
The competent medical writers develop any of five modules of the common technical document such as administrative and prescribing information, overview and summary of modules 3 to 5, Quality (pharmaceutical documentation, Preclinical (Pharmacology/Toxicology), Clinical – efficacy, and safety (Clinical Trials) and also need to familiar with searching medical literature, understanding and presenting research data, the document review process, and editing and publishing requirements.
The demand for medical writing has gone up considerably in the last few years in the pharmaceutical industry and healthcare communication market.
HOW MEDICAL WRITING CAME INTO EXISTENCE
- In pharmaceutical world medical writing erupted as an essential field because it requires specialized knowledge and skills to be able to write scientific documents which are well- structured, and presented in a clear and lucid manner.
- Clinical trials are systemic protocols that are complicated, tedious and protracted till it leads to market approval and this demand for well written, standards-compliant documents that medical and science professionals can easily and quickly read and understand.
TYPES OF MEDICAL WRITING
Medical writing comprises writing various types of documents for different purposes, and for different audiences. Subsequent examples for different kinds of medical writing are:
- Newspaper & magazine articles. These are frequently for general public and lay people and need to be written in simple, non-technical language.
- For Physicians – textbooks, learning management systems or virtual learning environment, Continued Medical Education (CME) programs, slide decks, e-learning modules
- For Patients – patient education material
Medical marketing of healthcare products
- Promotional literature targeted at healthcare professionals, product monographs, brochures, handouts
- Sales force training manuals, e-learning modules
- Internet content for physicians and patients (consumers)
- Journal articles / manuscripts (research articles, case reports, review articles)
- Posters & presentations for scientific meetings and conferences
- Clinical trial protocols
- Investigators′ Brochure
- Informed Consent Documents
- Study reports
- Research proposals
- Package Inserts (prescribing information) & Patient Information Leaflets
- Clinical study reports, web synopses
- Subject narratives
- Regulatory consent documents – Common Technical Document (CTD). Aggregate safety reports such as Periodic Safety Update Report (PSURs), Periodic Adverse Drug Experience Reports (PADER), Annual safety reports (ASR)s etc.
WHO REQUIRES MEDICAL WRITERS?
- Pharmaceutical & healthcare product commercial enterprises including medical device companies
- Contract Research Organizations (CROs)
- Business/Knowledge Process Outsourcing companies (BPOs/ KPOs)
- Scientific content & medical aid communication companies (Functional Service Providers)
- Medical Journals Academic medical institutions, Medical/scientific societies
- Media & Publishing companies
- Healthcare Websites
QUALITIES FOR EFFECTIVE MEDICAL WRITING
A professional medical writer (PMW) is the scientific writer expert with a biomedical degree (probably an advanced one such as a PhD) and has a sound understanding of biomedical research methodologies and knowledge of the current reporting guidelines as well as publication practices. The technical writer would have substantial data analytical skills with understanding in statistics. A PMW can help the researchers to analyse, organize, and present their data most effectively to achieve a set objective such as getting published in a respected journal, getting extra research funding, or finding acceptance for their work by their professional peers or the regulators.
In subsidiary to the above basic requirements, one needs domain knowledge & language skills.
- Medical & therapeutic area knowledge
- The drug development process, pharmacology, drug safety
- Technical guidelines
GENERAL KNOWLEDGE & LANGUAGE SKILLS
- Language & grammar
- Literature / reference searching
- Interpretation and presentation of research data
- Ethical & legal issues
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 general focused audience
- Thorough research of the subject
- Ability to find, 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 diverse people involved in the process
- Good time management
- Meeting deadlines and commitments
STEPS IN WRITING SCIENTIFIC DOCUMENTS
- Understanding the project brief
- Literature search & review of information
- Authoring & compiling the document
- The review process
- Formatting & editing
- Approval and sign off
- Electronic publishing
MEDICAL WRITERS PLAY PIVOTAL ROLE IN PUBLICATION MANUSCRIPT
Publication inscribers are medical writers who specialized in framing journal articles. Although this represents only a fraction of medical writing, it is an important part as publications are the main means by which researchers inform others about advances in medicine and influence clinical practice and prescribing.
1 Publications are therefore a key part of the communication plan for pharmaceutical, biotechnology and medical device companies,
2 and in many countries, peer-reviewed publications are the only information that can be cited in marketing materials. For manuscripts to pass peer review successfully, they must be well-organised, well-written and of high quality.
3 Professional writers improve the quality of writing, reduce the amount of time, cost and aggravation needed to deliver manuscripts, and reduce the risks and costs of unethical publication practices.
Publication writers do this in many ways. At the beginning of a manuscript writing project, a publication writer helps organise the project by creating specific milestones, such as insisting on the need for an outline, specified drafts and a defined internal review process. The publication writer then works with the authors to organize the information they want to publish by reviewing and considering the data from a naïve, unbiased perspective. A remarkable publication writer may challenge or elaborate on the authors’ interpretation and suggest alternative ways of presenting the data, thus adding to the quality of the writing. The publication writer will also delve into the details of the experiments and results to identify missing or incomplete information and places where the writing is not logical or may lead to questions or rejection. The publication writer should also help ensure that the article presents new and interesting information, which is the most important consideration for avoiding rejection. A key role of a publication writer is selecting an appropriate target journal for a manuscript, as an inappropriate journal is one of the main reasons that articles are rejected by journals. By doing this early in the writing process, the medical writer helps make sure that the article’s messages are correct for the intended audience avoiding time lost in submitting to inappropriate journals.
Whenever the writing begins, one of the major roles of the publication writer is to assist the authors write well. This includes making sure that language problems, a common reason for rejection, are avoided. The goal is to help the authors to transmit their main ideas in clear, concise and convincing language, which usually involves a combination of writing original text and reworking text provided by the authors. Moreover, a good medical writer can write a text that attracts and holds the attention of the reader. Sadly, many articles are rejected because they do not follow the journal’s instructions for authors. Part of the publication writer’s job is making sure that the article is in full compliance with these instructions.
How medical writers assist authors to publish journal articles?
Phillip S. Leventhal 4Clinics, Paris, France; Editor in Chief of Medical Writing; firstname.lastname@example.org European Science Editing 43 May 2013; 39(2) guidelines are followed, especially CONSORT, ICMJE and Good Publication Practice.
Articles that follow these guidelines attain a uniform level of quality and contain the full set of information needed for readers to understand and interpret the results. Furthermore, in the following guidelines, articles are more likely to be cited and included in systematic reviews, the main tool used by policymakers.
Although there may be a publication or project manager officially charged with managing the manuscript writing team, a publication writer often ends up filling this role.
This can include communicating with contributors, collating their comments, and chasing those who have not provided their comments. Publication writers can also save the author’s substantial time by organizing and guiding the manuscript writing process. Publication writers also create themselves worthful by maneuvering the authors through the review process. This can include helping the authors craft a well-written cover letter and abstract that capture the editor’s attention; calming authors when their article is rejected; responding appropriately and effectively to reviewers’ comments; editing the article according to reviewers’ comments; communicating with the journal editorial office; and, for rejected articles, finding a new target journal and correctly revising the article according to a new set of instructions for authors.
Medical writing is equally a science and an art. It requires an intellectual understanding of medical science and an aptitude for writing. In capitulation, a thorough knowledge of specific requirements for different types of medical documents, and keeping up to date with the relevant guidelines is a must.
They insist on medical writing is growing steadily over the years. The pharmaceutical and healthcare industry offers a number of employment opportunities for medical writers. Graduates and post-graduates in life sciences who have the right abilities and aptitude can consider taking up medical writing as a full-time profession.
Thank you for reading!
Content Writer : Dr.Clinsy Cleto