Medical writing and the healthcare industry
by Zheng Shan CHONG
Mention medical writing to most people and you’ll be met with confused and curious looks. ‘Does that mean writing about health issues in the newspapers?’ someone once asked me. This response isn’t surprising considering the largely behind-the-scenes role that medical writers play in the healthcare industry. Yet, the global medical writing market size has been valued at USD 1.72 billion in 2018 and is expected to grow 10.3% from 2019 to 2026, with the highest growth predicted to be in the Asia-Pacific region .
The reason for this growth? Increased outsourcing by pharmaceutical and biotechnology companies as well as tighter regulations by authorities, especially over transparent clinical trial reporting. Economic pressure from expiring patents and the high attrition rates of candidate compounds have already led to big pharmaceutical firms scaling down their workforces in order to increase R&D efficiency . This in turn has led to a concomitant increase in contract-based outsourcing of R&D activities including medical writing assignments. Indeed, the same factors that have fuelled the proliferation of biotechnology start-ups performing early-stage drug development research may also be contributing to increased demand for medical writing services.
In Asia specifically, growing interest in Asian markets by international companies, an abundance of scientifically and medically trained graduates, and increased recognition of medical writing as a profession have been cited as reasons for regional growth of the medical writing industry .
So, what exactly do medical writers do?
As highly regulated industries, pharmaceuticals and medical devices require complex and detailed documentation at each stage of development in order to be approved by the relevant authorities. After approval, the benefits and risks of using a particular product also have to be communicated simply and accurately to patients, healthcare professionals, as well as agencies tasked with informing clinical decision-making and improving patient outcomes. Medical writers can therefore have a range of responsibilities throughout the drug development lifecycle, from preparing publications at the non-clinical research stage, to writing clinical study protocols and reports, to producing material for educating end-users, patients and clinicians about a particular drug or device.
Medical writing can be divided into two distinct categories: regulatory writing and medical communications. As the name suggests, regulatory writing involves preparing dossiers for submission to regulatory authorities, typically for approval to market the drug or device in that region. Medical communications, on the other hand, focuses on educating and informing a more general audience such as patients and healthcare professionals about products that are already being marketed, rather than those under development. This involves writing for a wide variety of formats including newsletters, posters, slide decks, websites and manuscripts.
How do companies benefit?
Getting a promising drug or device to market in the fastest time at the lowest cost is the goal of many companies. Experienced medical writers that have worked with multiple regulatory agencies understand what is required of different applications as well as the relevant timelines, processes, and standards of each agency. ‘Medical writers are the last point of sense-checks before private, confidential data heads outside the company,’ says Dr Shawna Tan, a freelance medical writer. ‘We reduce the amount of back-and-forth between the company and the agency reviewers, which can severely impact product launch times.’
In addition, experienced medical writers can contribute cultural insights and knowledge of how regulatory submissions are approved even at early stages of clinical development to avoid costly mistakes. Dr Tan cites an example from outside Singapore, where a client had a licensing application returned without reason. ‘I gently pointed out that they’d forgotten specific aspects pertaining to the use of their device by Muslim women […]. They had to go back and reanalyse subgroups in a new trial, which cost them money and many months of research, and were ultimately not the first to market because of this oversight.’
Is a PhD necessary?
According to a survey of medical writing professionals in 2016, approximately 69% of respondents had PhDs or an equivalent qualification , indicating that having a PhD is preferable but not necessary for entering the profession. Strong writing skills and a good understanding of the drug/medical device development cycle is key. For people looking to transition from academia, networking with those already in the industry is very important for a better understanding of this career path and getting a foot in the door. To this end, non-profit organizations like Biotech Connection Singapore provide an ideal platform for general networking with non-academics in the healthcare sector, whilst international organisations like the American and European Medical Writers Associations hold regular conferences for networking within the medical writing industry. Webinars can also be a good way to learn more about the industry without spending a fortune on travelling, with sites like Medcomms Networking holding regular webinars on various topics pertinent to the industry.
In-house vs contract writing
Medical writers can be hired by a pharmaceutical/medical device company to work in-house, or by contract research organisations (CROs) and medical communications (Medcomms) agencies that provide medical writing services. Although these positions share overlapping responsibilities, the focus of each role and resulting career trajectories can be quite different. In-house medical writers oversee the documentation over the lifetime of product development and collaborate with physicians, researchers and statisticians to prepare manuscripts and regulatory documents. In contrast, contract medical writers work with multiple pharmaceutical/medical device sponsors and may be expected to perform different writing tasks in a range of topics within a short time. As a result, career development tracks for in-house medical writers include becoming technical experts or project managers, whilst contract medical writers may have better prospects transitioning to consulting and business development roles .
However, in-house positions are becoming less common as companies increasingly delegate parts of the R&D and marketing process to CROs and Medcomms agencies. In addition, medical writers in such organisations may also have access to more resources in terms of having a team of experienced writers and sometimes biostatisticians to share expertise, provide quality feedback and solve data issues . For this reason, many sources suggest that individuals looking to transition into medical writing should apply to CROs and Medcomms agencies before looking at in-house positions to gain the relevant experience and skill set required. In fact, some pharmaceutical and biotech companies will not hire inexperienced medical writers at all .
Outlook for medical writing in Singapore
Medical writing is a niche field which is growing in Asia. A quick search on LinkedIn turned up 12 results for regulatory writing jobs, as compared to 79 for medical communications, indicating that the latter enjoys greater demand locally. Medical writing could be a viable career choice for someone with a scientific background and strong interest in using their writing and communication skills to support the healthcare industry, if they are willing to gain the relevant experience and search for the right opportunities.
I thank Dr Shawna Tan for her valuable insights and advice over the course of researching and writing this article.
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