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Careers in Medical Writing: Regulatory Writing-- What's That Then?


Slaving over the test tubes on a cluttered laboratory bench is often only half the story of scientific research. Having a lab book full of brilliant results will only lead to Nobel Prizes (or on a more mundane level, continued financing) if the information is disseminated among the wider scientific community. It is the same for pharmaceutical companies, only their test tubes are often real people and the laboratory benches are frequently spread around the world. (They are still somewhat cluttered though!) The sheer volume of results generated in the development of a new drug is often too great for a pharmaceutical company to write up by itself, particularly when review articles, conference reports, and other literature all have to be prepared in order for the company to promote their product effectively and ethically. This is where professional communication agencies play an important role and is the usual interpretation given to the job title of medical writer, i.e., the production of manuscripts for peer-reviewed scientific journals.

However, there is another element of medical writing that has remained largely hidden, that of regulatory writing. Each country has its own national authority that must grant approval for any medicines to be marketed and sold there. In broad terms, a regulatory writer assists in the production of the clinical documentation required by these national regulatory agencies when assessing the safety and efficacy of drugs. The documentation ranges across the whole spectrum of drug development: Investigators' brochures provide information on all that is currently known about the medicine and so need periodic updating; accurate and concise protocols are required to ensure that trials are performed effectively; clinical trial reports (generally from phase II and III studies) present the information gathered from the trials; higher level documents provide summaries of efficacy and safety data from clinical trial programmes; expert reports provide critical interpretation of the results; and response documents clarify any points that are not clear to the regulatory agencies or provide additional analyses or supporting data for any items of concern.

A Team Sport

Of course, regulatory writers do not work in isolation on these documents. They often require input from a wide variety of people including medics, statisticians, and clinical research associates, who usually have the most comprehensive knowledge of trial procedures and access to all the bits of information that are not found anywhere else. This is probably one of the reasons that only a small number of communications agencies actually offer a regulatory writing service, but it is also one of the things that makes the job, for me anyway, more enjoyable. The chance to interact with people from outside your immediate discipline, to learn from them, and to offer your own advice and knowledge in terms of report content and presentation is a very rewarding experience.

The other aspect of the job that I find rewarding is the variety, not only in the type of documents that have to be written, but also in the different therapeutic areas I work in. Even within the writing of a single document, for example, a clinical trial report, the range of tasks that have to be completed, and the variety of skills utilised, is quite broad. Statistical tables and listings are reviewed to ensure that they contain the right information presented in a logical order and that there are no inconsistencies. For instance, in one trial it appeared that the patients from one country were all dwarfs, until it was realised that the height data had been recorded in inches rather than centimetres. In another case, some of the programming had gone awry and so information on the severity of death was recorded. (Patient A suffered a severe death, whilst Patient B had a mild death!) The references cited in the protocol are often several years old, and so updated information has to be found. Once the study team has reviewed the completed report (which obviously has to be written!), any conflicting suggestions for changes have to be resolved to everyone's satisfaction. Appendices accompanying the report have to be assembled, which often involves writing a brief medical history for certain patients who have suffered particular adverse events.

The Road to Regulatory Writing

My career path leading to medical writing was rather convoluted, a Brownian motion approach if you will. After completing a degree in biological sciences, I was invited to remain in academia and start on a doctorate investigating the use of lithium in the treatment of bipolar disorders. My particular field of expertise (or more correctly, least incompetence) was investigating interactions of the lithium ion with erythrocytes using nuclear magnetic resonance (NMR) spectroscopy. Three and a bit years later, I had changed from postgrad to postdoc and found myself helping to organise congresses, supervising students, dabbling in lecturing, and also continuing my own esoteric line of research. Hanging around the chemistry labs for too long (I blame the NMR magnetic field) resulted in a switch of research topics to theoretical chemistry, which I was happy to do until the funding ran dry. After a short spell as a lecturer/visiting lecturer in biological psychology (don't even ask), I had to face up to financial reality and find a job! Rescued from insolvency by a pharmaceutical company, I found myself labelled as a medical writer. Restructuring of the company resulted in my joining a communications agency, where I have been merrily (well, there is a pub next door!) plying my trade for the past 5 years.

Of course, as with any job, there are frustrations. There are the pressures of tight deadlines, delays in availability of data, differences of opinion on content, and, a particular personal bugbear, the arrival of late comments when one had thought everything was finally perfect. In compensation, one can get quite involved in the clinical programme. It is exciting when the results of a trial I have been working on come out positive. There is real satisfaction in knowing that one's work has, hopefully, helped to get that drug approved for use in the general population. The successful completion of a response document is particularly satisfying, as one has clarified an item of concern and represented the information in a form that was not immediately apparent in its original format, which is what the art of effective communication is about.

Would I Be a Good Regulatory Writer?

Attention to detail and conciseness of presentation are important aspects of the job, so a good, clear CV is essential. (Statements like "I am an expert prof-reader" don't go down well!) A lot of clinical documentation is produced according to strict guidelines, so if you are given a writing test, stick exactly to what is asked for; if you are not sure, ask. Because the job will invariably involve liaising with people from a variety of disciplines, you must be able to get on with other people and also be able to defend your corner if need be. General knowledge of statistics is helpful but not essential, but one must not be afraid of large piles of listings full of data. A logical approach to work and the ability to report the facts accurately, simply, and concisely are very important, as is a certain amount of creativity and problem-solving ability. Overall though, a good regulatory writer must have enthusiasm for handling data; possess that quality and the rest comes relatively easily!