What is a Medical Writer

What is A Medical Writer? A Closer Look at This Increasingly In-Demand Job

In medical science, there’s a constant need for accurate information to be shared correctly. Health workers and patients need continuous education about treatments, so here, the medical writer comes to the stage. Surprisingly, although medical writing is a familiar job, the estimations suggest its growth of about 10% annually by 2030. (1)

What does medical writing practically mean? The medical writer creates and develops essential documents for regulatory bodies about new chemical entities, medical devices, biologics, and treatment options for approval for use in patients. Furthermore, medical writing involves creating manuscripts, educational materials for healthcare workers or patients, and more.

Nowadays, with the possibility to work remotely and for yourself for the average hourly rate of $113, medical writing has become an attractive freelance job compared to past years. (2)

If you have yet to examine the medical writer’s job closely, this article provides an overview. Keep reading to understand what medical writers do specifically. You can also learn about the skills and competencies of esteemed medical writers.

High-Quality Documents That Medical Writers Create

Medical writers produce a broad spectrum of medical documentation for different target audiences. Medical writing can be divided into two chapters:

  • Regulatory writing;
  • Medical communication.
What is A Medical Writer

High-Quality Documents That Medical Writers Create

What is Regulatory Medical Writing

Regulatory medical writing is involved in the research and development phase of new drugs, biologics, or medical devices. The regulatory writer creates a bridge to regulatory authorities by creating the necessary product documentation. This allows them to assess the document for authorization and approval.

While many of the documents are prepared before the product gets approved, still, some are created after. Here are some examples of regulatory writing documentation:

Clinical Study Report (CSR)

A CSR is a report containing all data related to individual patient studies. Once submitted, the regulatory body will assess the information where data are integrated into a pre-defined structure.
Guidance on writing CSRs is provided by regulatory bodies such as the Food and Drug Administration (FDA) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), not ‘ICS region. (3)

Investigator’s Brochure (IB)

An IB is a document that briefly describes a drug under investigation and summarizes its characteristics, including:

  • Pharmacological effects;
  • Pharmacokinetics;
  • Safety profile;
  • Toxicological profile; and
  • Efficacy in the management of the condition of interest. (4)

Risk Management Plan (RMP)

Risk Management Plans (RMPs) are primarily designed to identify, characterize, prevent, or minimize risks related to medicinal products, including the assessment of the risk of shortage. Still, their main focus is on the safety profile of the drug. For this reason, manufacturers must obtain RMP, which medical writers prepare. (5)

  • Medical writers create many other regulatory documents, such as:
  • Clinical development plan (CDP);
  • Clinical study protocol (CSP);
  • Pediatric investigation plan (PIP);
  • Informed consent (IC);
  • Common technical document (CTD);
  • Periodic safety update report (PSUR).

Creating regulatory documentation requires following strict guidelines and regulations defined by the FDA for the U.S., the European Medicines Agency (EMA), and other national drug agencies (6, 7). Thus, the medical writer must meet the Regulatory bodies’ requirements when creating the content.

In addition to guidance implementation, the document should be written in a language understandable to the authorities. Therefore, the medical writer needs to adapt the language to the target readers.

A regulatory medical writer is more than a technical writer who follows strict guidelines. The medical writer is a member of a protocol review team, along with the investigators, medical and safety experts, statisticians, and other experts. Thus, this role requires strong verbal and written communication skills. (8)

There are other skills expected from the regulatory writer; keep reading the article to find out.

What is Medical Communication

Medical communication (MedComms) is an extension of regulatory writing, a continuum of medical content creation, mainly after a product’s approval. Manufacturers of medications, biologics, or medical devices want to inform anyone who needs their product about the latest research findings on its use. So, MedComms is all about this and even more.

The American Medical Writers Association (AMWA) defines medical communication as developing and producing materials that deal specifically with medicine or health care. Medical writers, in collaboration with others, prepare a variety of materials, including:

  • Systematic reviews;
  • Journal articles;
  • Peer-reviewed manuscripts;
  • Conference abstracts;
  • Posters; (9)

Medical communicators should understand the therapeutic area and disease, research methodology, statistics, and data interpretation to write scientific articles for publication (original research, systematic review, meta-analysis, etc.). The medical writer will also support the analysis and data interpretation while creating a presentation for Congress.

Medical communicators should know and follow the guidelines defined by scientific journals. The know-how and the details are in the writer’s hands. On top of this, medical writers implement ethical standards in content creation.

Medical Communication Entails A Broader Spectrum Of Content

Medical writers make tremendous contributions in creating other documents such as:

  • Side kits for oral presentations at congresses or educational events;
  • Educational materials for physicians;
  • Teaching materials for sales representatives;
  • Patient educational materials;
  • Website content;
  • Grant proposals, etc. (9)

Preparation of slide kits requires experience in creating PowerPoint presentations, a deep understanding of the subject matter, and the ability to present complex information clearly and effectively. However, for some practitioners dedicated to their clinical practice and patients, this can burden their daily routine.

Writing educational materials requires a systematic approach to logically compiling the whole content. Moreover, writing educational materials for patients should be done in plain language to ensure their collaboration and understanding and to achieve maximum treatment effect safely. Imagine the reaction of the patient reading a brochure full of medical terminology that only a clinician can understand.


Writing promotional medical content is another story. Copywriters are writers who specialize in producing advertising materials for different target groups. When promoting a product, they highlight its advantages in a balanced, accurate, and sometimes misleading way.

While regulatory medical writing focuses on the regulatory bodies, MedComms has a broader target audience auditorium, such as clinicians, practitioners, nurses, pharmacists, and patients. So, the language and style vary and should be adopted from peer-to-peer to patients or other specialized professionals. (10)

How to Become a Great Medical Writer

This question is familiar, and the answers are known for many years. In his 2010 publication, Dr. Sharma addresses specific skills and aptitudes the medical writer needs, as well as familiarity with medical terminology and the ability to write grammatically correct, clear, concise content. (11)

Many medical writers have medical or life science educational backgrounds. Ideally, they possess a university degree in medicine, pharmacy, veterinary, or life sciences. Certain writing job positions require a Master of Science, PharmD, or Ph.D. (12)

Aside from these, other great writers have university degrees in language and communication. For more than 30 years, many Universities worldwide have specially designed programs for Science Communication and have educated students theoretically and practically. (13-14)

Skills And Competences

If you thought that medical writing was a tedious office-based job, sitting in front of a computer and typing all day, then let me show you what the job is about.

Medical and scientific knowledge and passion for writing are not all you need to be a great medical writer; you also need specific skills and competencies.

Strong research and critical thinking are skills that the medical writer should adopt. In addition to verbal and written communication, you should also have visual communication skills.

As part of a research and clinical investigation team, the medical writer should listen actively and know how to interpret and present data accurately and clearly. Attention to detail, problem-solving, agility, patience, and proactivity are soft skills that great medical writers also possess.

A regulatory medical writer is beyond a high-quality writer. This job requires skilled skills in stakeholder engagement document management systems and good clinical practice knowledge. (15)

As a communicator, the medical writer should be flexible and adaptable to collaborate with different teams. Medcooms enable working on various projects, some of which run in parallel. Therefore, time and project management, responsiveness, and on-time delivery are essential for this role.

The content produced by the medical writer is subject to further check and editing by superiors and partner organizations. For this reason, as a medical writer, you should listen actively and be prepared for feedback and criticism to improve your work; it’s nothing personal. (10)

Knowing that medical writers work in medical communication agencies, contract research organizations, and pharmaceutical and biotechnology companies, it is clear why all these skills and competencies are so critical.

Medical Writer: A Valuable Team Member

Medical writers’ work goes beyond writing great medical content. With their abilities and skills, medical writers support authors and sponsors to make the results of their research available in journals and scientific congresses. Their contribution to producing educational materials for healthcare providers or patients adds value to healthcare education improvement.

Becoming an esteemed medical writer and building a successful career requires continuous education, building capabilities, and strengthening skills for writing on top of your knowledge in writing and science.

The American Medical Writers Association (AMWA) is one of several professional organizations offering resources, educational programs, and certification for medical writers, and aspiring writers may benefit from exploring a variety of professional associations. As a leading professional organization, AMWA offers educational programs, online learning and certification, valuable sources, and career support. As a member, you can use the advantages of the association to upgrade your knowledge.

Finally, to become a great medical writer, you should write and learn from your own experience. The best way is to learn on the job and put into practice the theoretical knowledge you get through the years.

See Also

How to Become a Physician

How to Become an Osteopathic Physician

How to Become a Pharmaceutical Scientist

How to Become a Dentist

How to Become an EMT (Emergency Medical Technician)

How to Become a Patient Educator?

How to Become a Physician’s Assistant in 5 Steps

Current Version
March 7, 2024
Updated By
Franco Cuevas, MD
August 4, 2023
Edited By
Franco Cuevas, MD
August 1, 2023
Written By
Biljana Srbinovska, MPharm
  1. Polaris Market Research, Medical Writing Market Share, Size, Trends, Industry Analysis Report, By Type (Medical Writing, Scientific Writing, Regulatory Writing, Others); By Application, By End-User (Pharmaceutical Companies, CRO, Others); By Region; Segment Forecast, 2022 – 2030, Jun 2022 https://www.polarismarketresearch.com/industry-analysis/medical-writing-market
  2. American Medical Writers Association, Executive Summary of the AMWA 2019 Medical Communication Compensation Report, AMWA Journal, 2019, V34 N3 https://cdn.ymaws.com/www.amwa.org/resource/resmgr/journal/issues/2019/AMWA_J_34.3_online.pdf
  3. Food and Drug Administration, Guideline for Industry, Structure and Content of Clinical Study Reports, July 1996, ICH E3 https://www.fda.gov/media/71271/download
  4. Food and Drug Administration, IND Applications for Clinical Investigations: Regulatory and Administrative Components, Mar 2022 https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-applications-clinical-investigations-regulatory-and-administrative-components
  5. Food and Drug Administration, Risk Management Plans to Mitigate the Potential for Drug Shortages, May 2022 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/risk-management-plans-mitigate-potential-drug-shortages
  6. Food and Drug Administration, Guidance, Jan 2022, https://www.fda.gov/industry/fda-basics-industry/guidances
  7. European Medicines Agency, EMA launches checklist to facilitate validation for initial marketing authorization applications, Feb 2019 https://www.ema.europa.eu/en/news/ema-launches-checklist-facilitate-validation-initial-marketing-authorisation-applications
  8. Kishor P. Patil, Chandra Kumar, Siu-Long Yao, Peer review of a clinical trial protocol: Practical tips for regulatory medical writers, clinicians, and clinical scientists, Medical Writing, Mar 2023, Volume 32, Issue 1 – Clinical Trials https://journal.emwa.org/clinical-trials/peer-review-of-a-clinical-trial-protocol-practical-tips-for-regulatory-medical-writers-clinicians-and-clinical-scientists/
  9. American Medical Writers Association, About Medical Communication https://www.amwa.org/page/Med_Communication
  10. Yfke Hager, Medical Communications: The “Write” Career Path for You?, Cold Spring Harb Perspect Biol 2019;11:a032953 https://cshperspectives.cshlp.org/content/11/1/a032953.full
  11. Suhasini Sharma, How to Become a Competent Medical Writer?, Perspect Clin Res. 2010 Jan-Mar; 1(1): 33–37. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3149406/
  12. American Medical Writers Association, Ultimate Guide to Becoming a Medical Writer https://info.amwa.org/ultimate-guide-to-becoming-a-medical-writer#what_does_it_take_to_be_a_medical_writer
  13. F.Mellor, Twenty years of teaching science communication: A case study of Imperial College’s Master’s programme, Public Understanding of Science, 22(8) 916–926 https://cyberleninka.org/article/n/1192730/viewer
  14. J. Verran, S. Illingworth, J. Pritchett, and J. Redfern, Teaching Medical Writing, Medical Writing, 2023;32(1)92-98. https://journal.emwa.org/clinical-trials/teaching-medical-writing/
  15. Kishor P. Patil, Chandra Kumar, Siu-Long Yao, Peer review of a clinical trial protocol: Practical tips for regulatory medical writers, clinicians, and clinical scientists, Medical Writing, Mar 2023, Volume 32, Issue 1 – Clinical Trials https://journal.emwa.org/clinical-trials/peer-review-of-a-clinical-trial-protocol-practical-tips-for-regulatory-medical-writers-clinicians-and-clinical-scientists/

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