What is Medical Writing? A Beginner’s Guide for Early-Career Researchers

Imagine sitting in the waiting room of a dentist’s office. On the table lie brochures that enlighten you about how to maintain your overall dental health. However, instead of bombarding you with complex, scientific terminologies and vocabulary, the brochures provide the details required for you to understand the best way forward with respect to your dental caring.  

These brochures were perhaps prepared a medical writer with the intention of informing and guiding the patients.  

What is Medical Writing? 

Types of Medical Writing 

Skills Needed for Medical Writers 

What is Medical Writing?

Simply put, medical writing transforms complex medical information into clear, easily discernible content for various audiences involved in the healthcare, pharmaceutical, and research industries. The content ranges from regulatory documents and marketing materials to clinical reports and informational brochures. All these content types are directed toward one goal—convey complex scientific knowledge in a simple and accurate manner for specific audiences.  

Types of Medical Writing

Medical writing can be broadly classified into two types: regulatory and non-regulatory medical writing.  

Regulatory medical writing

• Regulatory medical writing involves the creation of documents for submission to regulatory bodies or agencies, such as the FDA. It can be for getting approvals for newly developed medical devices or drugs. 
• The documents can be submission dossiers, clinical protocols, or reports of clinical studies that adhere to the guidelines set by these agencies. 
• The target audience is the committee that reviews regulatory submissions. So, the content should represent accurate data of clinical research, ensuring compliance with regulatory guidelines. 

Non-regulatory medical writing

• Non-regulatory medical writing refers to preparing content for a broader audience. This includes educational materials, scientific publications, medical journalism, and marketing content. 
• Educational materials: Medical writers prepare various formats of educational content, such as training materials, including assessments and slide decks, for pharmaceutical and biotech companies. 
• Scientific publications: Writing manuscripts or abstracts for journal submissions, especially focused on advancing research in the medical field, is another type of non-regulatory medical writing. Here, a medical writer will work closely with scientists and researchers, assisting them in preparing conference posters or manuscript submissions for peer-reviewed journals. 
• Medical journalism: There are many websites that publish health-related blogposts that are directed at a general audience. Medical writers summarize relevant content for such websites and prepare news releases for updated in the healthcare industry such that they are easily consumable by lay persons. 
• Marketing content: Say a pharmaceutical company wishes to promote a latest product developed by them. They rely on medical writers to create materials for promoting this newly developed drug or medical device. These can be social media posts, website content, or even posters advertising the product. 

All these types of writing require a unique skill set that cater to a specific audience. So, how does one become a medical writer?  

Skills Needed for Medical Writers

Clinical research often generates vast amounts of scientifically complex data, which should be translated accurately and disseminated to various audiences. Therefore, exploring the line of medical writing can be a great opportunity for students and early-career researchers in the medical field. However, the skills of a medical writer go beyond ordinary writing and editing. 

• Strong scientific knowledge: The core of any medical document is the science behind it. And because medical writers collaborate with doctors, physicians, and clinical researchers, a strong foundation in medical science is a must!
  You need to be able to understand what the research intends to report and convey it to the audience in a manner that’s not too overwhelming. You serve as the bridge between science and the audience. This means you need strong interpretation and presentation skills. 
• Communicating effectively through written posts: It goes without saying that writing is a key skill required for medical writers. While scientists may thrive in investigating a problem or conducting extensive research on a new medical intervention, communicating their findings may not be their strongest suit.
  Enter the medical writer! Knowing how to write with clarity while maintaining conciseness and precision with sufficient attention to detail is a skill that needs to be honed. You must also learn to customize your phrasing and language for different audiences, such as patients, regulatory bodies, policymakers, and other healthcare professionals.
• Reviewing abilities: As mentioned earlier, both interpretation and presentation are key skills required for a medical writer. This is because when vast amounts of clinical research data are presented to you, you should be able to review and analyze them thoroughly before beginning to translate them into simple, easy-to-consume content formats.
  For instance, ask yourself these questions:
  a) How has the researcher interpreted the findings?
  b) What is the knowledge level of the target audience?
  c) How best can I present the findings in a way that shows impact?
  Answering these questions should be the starting point for a medical writer when working on any type of document.
• Knowledge of industry-specific guidelines: Medical writers should be familiar with standard industry guidelines, especially those that are relevant to regulatory medical writing. For instance, the International Council for Harmonization (ICH)¹ outlines quality, safety, efficacy, and multidisciplinary guidelines for harmonizing regulatory requirements. There are also guidelines set by regulatory agencies such as the FDA and other regional administrations that need to be followed.
  Apart from these, it is good to know the ethical and publication guidelines, like the consolidated standard of reporting trials (CONSORT)² guidelines for randomized controlled trials and other reporting guidelines for research. And of course, familiarize yourself with standard international style guides, such as the American Medical Association (AMA)³ manual of style to help you format medical documents suitably.  

References

1. ICH guidelines https://www.ich.org/page/ich-guidelines

2. CONSORT guidelines https://www.consort-spirit.org/

3. AMA manual of style https://academic.oup.com/amamanualofstyle/pages/about