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A medical writer is one of the most in-demand resources in the healthcare industry today. At every step of medical research or product development, there is a writing exercise involved, one you may be familiar with. You might have spent hours trying to put together a coherent research report, or days trying to finish an application for a grant. Your team might be spending precious time and energy putting together a 100-page regulatory document. A professional medical writer can take those hours off you, and take on the job of developing communications that meet regulatory, ethical and legal standards. Here are 4 ways a freelance medical writer can help you.
1. Regulatory documentation/applications for new drug approvals
The regulatory documents that are required during the drug development process are crucial for the success of the drug. These documents play a key role in getting an approval or a license to be able to manufacture and sell a new drug.
An article in the Journal of Clinical and Diagnostic Research says: “The most difficult stage of conducting a research project is the preparation of a protocol that results in a short yet comprehensive document that clearly summarizes the project. Such proposal is considered successful when it is clear, free of typographical errors, accurate and easy to read.”
Often, experts and scientists within the organization try to put together these documents — however, they face the risk of inconsistencies that might creep in when multiple experts write different parts of a document. Experts are also likely to use technical terms and jargon without realizing they might need to explain and elaborate so that the reviewers are able to read and understand the proposal easily. A medical writer can develop a comprehensive strategy for all the writing work involved, and can document the clinical research with consistency, accuracy and precision. Formatting plays a key role here, as reports might have been written by multiple scientists — it is the job of the writer to develop and apply a standard formatting/editing template. Clinical trial studies and protocols, animal studies, details of the drug composition — all of this and more has to be documented and summarized for the drug application. The documentation has to be written according to a specific format and regulatory guidelines. Once the drug is approved, all the content that is developed regarding its usage also has to be within the prescribed guidelines.
The FDA’s New Drug Application (NDA) follows the Common Technical Document format, which is divided into five modules that combine clinical studies, a non-clinical overview, and various study reports. A Quora user offers some insight into the process (while also suggesting that it might take about half a year to write the NDA from scratch, though that isn’t practically the case).
2. Grant writing/application for funding (healthcare NGOs)
Nonprofits, government organizations and NGOs depend on excellent writers for getting funds and grants. A medical writer can help a healthcare nonprofit in two ways: one, by putting together a grant proposal or an application for funding, and two, by consolidating all the information into a quarterly/annual report to record progress. Smaller agencies and nonprofits usually have limited funds to work with, and might not be able to afford a full-time in-house medical writer. Hiring a freelance medical writer helps them save their resources while also outsourcing their work to a specialist. Recently, a national health organization in the US hired a freelance contract writer on Kolabtree to develop a well-cited annual report that could be presented to the Congress and federal agencies to influence a change in health policy. The writer, a specialist in epidemiology and technical writing, was able to put together a comprehensive report from various sources at a fraction of what it might cost to hire an in-house medical writer.
3. Research paper publication
Scientists, researchers and those involved in product development or R&D are constantly innovating and coming up with novel techniques, methods, devices and drugs. This research is published in academic journals and/or is presented at conferences. However, getting published in a high-quality journal is no easy task — research has to be compiled, analyzed, reviewed and prepared according to the required format. The success rates are also low: Nature, for example, publishes only about 8% of the 200 papers submitted each week.
A study in Current Medical Research and Opinion by Woolley et al. states, “For example, when professional medical writers help authors prepare manuscripts, these manuscripts are less likely to be retracted for misconduct, are more compliant with best-practice reporting guidelines, and are accepted more quickly for publication.”
Presenting research data correctly is something many researchers struggle with. Support from a medical writer improves their chances of being published in a reputed journal and accelerates the submission process.
4. Content writing
Misinformation in medical communication can be highly detrimental not just to the manufacturer or organization but also to the various stakeholders involved, including patients. It is imperative to hire a medical writer with the right background and experience for your task. Medical writers also help with developing marketing, promotional, packaging and educational material. From content writing for prescription drugs to educational website content, every detail has to be absolutely correct. When you hire a medical content writer, you can rest assured that you’ve found someone who can spell otorhinolaryngologist and who can take a decision on whether to use slipped ‘disc’ or slipped ‘disk’, ‘caesarean’ or ‘cesarean’.
Medical writers work either independently or as part of agencies, CROs and consultancies. Platforms like Kolabtree help healthcare organizations find certified editors and medical writers with a scientific background to develop a research paper, report or clinical study protocol. Outsourcing your task to a professional medical writer means that you not only have more hours a day to focus on things important to you, but you are also closer to getting your product approved, research paper published, and project funded.