What is A Medical Writer? A Closer Look at This Increasingly In-Demand Job
In the world of medical science, there’s a constant need for accurate information 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 practically means being a medical writer? The medical writer creates and develops essential documents for regulatory bodies about new chemical entities, medical devices, biologics, and new treatment options for approval for use in patients. Furthermore, medical writing is about 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 than in the past years. (2)
If you have yet to look closely at what the medical writer’s job is, this article gives an overview. Keep reading to understand what medical writers specifically do. You can also find out the skills and competencies esteemed medical writers have.
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 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 making the necessary product documentation. In this way, they can 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.
There is available guidance on how to write CSR issued by the Food and Drug Administration (FDA) and other agencies of the ICS region (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use). (3)
Investigator’s Brochure (IB)
An IB is a document that briefly describes a drug under investigation and summarizes its characteristics, including:
- Pharmacological effects;
- Safety profile;
- Toxicological profile; and
- Efficacy in the management of the condition of interest. (4)
Risk Management Plan (RMP)
Once the drug or biological product for human use becomes available on the market, there must be a plan to identify proactively and mitigate risks in case of a shortage. 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 needs to 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 in addition to 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 the approval of a product. Manufacturers of medications, biologics, or medical devices want to inform anyone who needs their product with 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 it, medical writer implements 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)
For those experienced in creating PowerPoint presentations, slide kit preparation is an easy job. 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 in plain language to ensure their collaboration and understanding and to achieve maximal 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 way, accurately and without misleading at the same time.
While regulatory medical writing focuses on the regulatory bodies, MedComms have 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. Dr. Sharma, in his publication from 2010, addresses specific skills and aptitudes the medical writer needs, in addition to medical terminology familiarity and the ability to write grammatically correct clear, and 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.
To start with, strong research and critical thinking are skills that the medical writer should adopt. In addition to verbal and written, 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 being skilled in stakeholder engagement, document management systems and well-versed in Good Clinical Practice. (15)
As a communicator, the medical writer should be flexible and adaptable to collaborate with different teams. Medcooms enable working on various projects, and some 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/or 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.
AMWA is probably the first gate for medical writers. 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, write and learn from your own experience. The best way is to learn on-job and put into practice the theoretical knowledge you get through the years.