Medical writers make up much of the medical device regulatory industry. In fact, they are one of the largest contributors behind the thousands of devices that get conformity approval each year.
However, good medical writers are hard to come by. The thing is, you need a very specific set of skills to become a talented medical writer. You need to hire someone who is proficient in technical writing jobs but at the same time has thorough knowledge and clinical understanding close to healthcare professionals.
The reason many medical device companies and pharmaceutical companies look for such high qualifications is that they don’t want writers to do generic work for their devices. They don’t want the same cookie-cutter file submitted for every device. Instead, they want the medical writer to work along with their research team, understand the goal and objective, and make sure the technical documents reflect the entirety of the device and not merely the parameters.
So, how do you find such medical writers? In this article, we will explore some of the must-have medical writing qualifications to look for.
When you are hiring someone for scientific writing, make sure they have the correct scientific background. Usually, medical writers will have a bachelor’s degree in science, technology, and biological sciences. A degree in a health science subject, such as biology, medicine, or pharmacology, is preferred, but it is not usually required. Check for specific certification from organizations such as the American Medical Writers Association (AMWA) or the European Medical Writers Association.
Any prior experience in research organizations or academic research is also highly appreciated. Writers with research experience have a better grasp of scientific writing, as they can correlate regulatory documents with medical devices easily.
Experience is highly valuable in medical writing jobs. Let’s face it: for any regular person, the EU MDR’s various requirements, guidelines, and fine print are difficult to keep track of. Regardless of your academic qualifications, if you are not familiar with the regulations, you are bound to miss something eventually.
That is why, when hiring, look for people who have worked in regulations for a fair amount of time. The more diverse their portfolio is, the better. Because when a medical writer has worked on several devices for several years, it’s fair to assume they know what they are doing. These medical writers would know exactly which regulatory requirement could land you in hot water and which ones the notified bodies won’t bug you about.
An experienced writer is also usually a competent medical writer. They will have no problem understanding medical terminology, will work easily with clinical study reports and clinical trial data, and will know their way around scientific publications, etc.
When interviewing, request writing samples or a portfolio of their work to obtain a sense of their writing style, accuracy, and tone. If a candidate’s experience matches the project requirements, such as regulatory writing or decision summaries, or if they have experience writing about specific medical fields or topics, such as oncology, cardiology, or neurology, that’s a bonus!
Also, just to be sure, ask for references from previous clients and employers. A decent writer should have a few!
Technical Writing Skills
Okay, so this is a given. A medical writer should, you know, be able to do medical and technical writing. Technical writing skills are not the same as regular writing skills. Medical writing is all about creating exact, short, and well-structured technical sentences that portray the device’s safety and performance effectively and convincingly. There is a lot to do here, and it’s all just not possible by someone not versed in technical guidelines.
Expert medical writers are also proficient in regular writing abilities such as grammar, punctuation, and syntax. They are also familiar with applicable guidelines such as AMA Style, ICMJE, and EASE Guidelines.
Eye for Details
The technical documentation you submit to the authorities carries your device’s entire life cycle and background information. The notified body and experts will go through these documents first, use these documents to assess your device, and keep these for future reference. Anytime your device comes to them, they will review these technical documents for reference. Suffice it to say you do not want to mess up any detail in the technical documents and clinical evaluation report.
Excellent medical writers pay close attention to detail, ensuring that the documentation is free of errors and inconsistencies. They understand that even little inconsistencies might have severe consequences. For example, imagine a writer used centimeters in the technical documents while your team used inches in the clinical study reports and clinical trials. Small mistakes like these are very hard to catch (even if you review the document prior to submission) but could hinder regulatory approval.
Medical writing is not a solo job. It involves many people and teams. Effective medical writers have good communication skills. Plus, a lot of the time, they might have to communicate with clients and other stakeholders. It’s important that they can translate medical science terminology into layman’s terms, extract data, and present them in a comprehensive manner.
We are all on a schedule! Sure, medical writing projects can be time-consuming. But too often, they require a speedy turnaround for easy assessment and comparison. Medical writers must be efficient in order to complete their work within the deadline. This necessitates exceptional organizational and prioritization abilities.
This is pretty important. Medical writers are usually familiar with regulatory regulations. However, they might be more comfortable with a single regulatory authority. For example, not all medical writers will be well-versed in FDA regulations, especially if they work primarily with European companies and vice-versa.
If you have a multinational company, it’s best to look for several writers or hire writers familiar with regulatory authorities’ regulations and recommendations from various countries, such as the FDA and MDR.
The bottom line is that a regulatory-savvy medical writer can assist manufacturers in navigating the complex regulatory landscape and avoiding costly delays or rejections. It’s not necessary for them to have all of the medical writer qualifications mentioned above, but a good writer probably will have more of these than the others.