At every step of medical research or product development, there is a writing exercise involved. Whether it is a grant application or medical product description, all healthcare communications have to be aligned with regulatory, ethical and legal standards. Professional medical writers continue to be in demand in pharma companies, contract research organizations and healthcare agencies. According to Glassdoor, the national average salary of a medical writer in the USA per year is $93,018.
In the last few years, the gig economy has taken over the medical communications industry in a big way. Medical writers are choosing to take the freelance route for the flexibility and freedom it offers. This works as a benefit for healthcare companies, especially small to medium-sized businesses, who can now afford to hire freelance writers, on demand.
A frequent concern for businesses when considering a freelancer versus in-house is the resources required to get a freelancer up to speed. However platforms like Kolabtree host freelancers with in-depth specialist knowledge, many of whom have vast experience and are able to hit the ground running.
Here are four areas in the healthcare industry which call for a medical writer’s expertise.
1. Regulatory documentation/applications for new drug approvals
It can take 15-20 years for a new drug to enter the market. The regulatory documents prepared 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 from a regulatory agency (such as the FDA in the US or the MHRA in the UK) that allows them to manufacture and sell a new drug.
A medical writer can develop a comprehensive strategy for all the writing work involved, and can document clinical research with consistency, accuracy and precision. Formatting plays a key role here, as various 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 these and more have to be documented and summarized for the drug application. The documentation has to be written according to a specific format and regulatory 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. Filling out the application can take several weeks to a few months, in which case outsourcing this task to a specialist helps save time. Once the drug is approved, all the content and marketing communications that is developed regarding its usage has to be within the prescribed guidelines.
The American Medical Writers Association states that, “Medical communicators should write, edit, or participate in the development of information that meets the highest professional standards, whether or not such materials come under the purview of any regulatory agency. They should attempt to prevent the perpetuation of incorrect information.”
2. Grant writing/applications for funding
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.
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.
According to the FDA, “All advertisements, such as product claims or reminder ads, cannot be false or misleading. They must contain truthful information about a drug’s effectiveness, side effects, and prescribing information.”
Medical writers work either independently or as part of agencies, CROs and consultancies. Platforms like Kolabtree help healthcare organizations find certified freelance editors and medical writers with PhDs, who can develop a research paper, medical report or clinical study protocol. Outsourcing tasks to a freelance 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.