Careers in Medical Writing: Clinical Writing--An Entry into the World of Biotech


Leaving the comforts of academia for industry is a somewhat daunting step. For many years, one is groomed and expected to follow the traditional path from Ph.D. to one, two, or even three postdoctoral positions, and then to apply for a position at a university. It is easy and comforting to picture how your academic career is supposed to unfold. If nothing else, you know that you will be "postdocing" for the foreseeable future. The career path in industry is not nearly as well defined. Making the crossover requires a certain amount of trust that the skills you have developed in graduate school will not only help you find a job in industry but will allow you to choose a career path that is as satisfying and rewarding as the one you left.

When I first considered a job in industry, I had a tough time imagining how I would find one suited to me. I had lots of questions: What jobs am I capable of doing? What jobs are actually being done in industry? How much science would be involved in an industry job? None of the jobs that were being advertised, or which industry representatives from major pharmaceutical companies talked about, seemed to be a perfect match for the skills I had developed. It is perhaps this feeling, that of not utilizing all your skills and knowledge that you have worked so hard for, that presents the biggest barrier to chancing it in industry.

In my case, I took the leap into industry by way of a clinical writing job in a promising biotech company involved in phase II and phase III studies of its product. Within 1 year of starting at Hemosol, the job I was initially hired to do has: 1) allowed me to develop a clear picture of the biotech industry, 2) taught me a great deal about the clinical research process, 3) allowed me to move into new roles in the company that specifically match my wants and needs, and finally 4) helped me see that there are enough career paths in industry to keep me excited and challenged to the day I retire.

My training was typical: a master's and Ph.D. in pharmacology in incredibly specific fields that only excite a handful of scientists in the world. My field of research, which involved studying intracellular protein interactions, had little in common with the blood substitute for use in surgery that was being developed at Hemosol. It was my general background in pharmacology, as well as the book learning and critical thinking skills that I developed as a graduate student, that the company found appealing. Of course my experience in manuscript and grant writing also helped.

What does clinical writing involve? As part of a team of Ph.D.s and M.D.s, my initial duties were to write up the results of several phase II and phase III studies that were to be submitted as part of the regulatory process for approval of the product. Specifically, I was involved in writing up the results of the efficacy analysis and the related discussion. Clinical writing, especially for regulatory reports, follows strict guidelines set up by organizations such as the U.S. Food and Drug Administration and the International Conference on Harmonisation. The whole clinical process must follow Good Clinical Practice guidelines that, in the case of clinical report writing, demand extreme care in presenting the data objectively and accurately. As part of my initial duties at the company, I learned how the reports were put together and how the many tables and figures and listings of raw data are presented. This in itself was a valuable learning experience. The days were often hectic and exciting as deadlines, often based on ambitious business goals, set a rapid pace. After about 3 months, I really felt comfortable in my new setting and felt that I was contributing significantly to the clinical process.

In the process of writing sections of these reports, I soon found myself with additional tasks and responsibilities that took advantage of my skills. While earning my master's, I had gained some experience with SAS programming and statistics. I now had the opportunity to use these skills (and expand on them) to analyze some of the data from the clinical trials. Imagine that: the pleasure of thinking about results without having to do the tedious experiments necessary to generate them! Through the writing process, I learned all about the science and medicine related to blood and blood substitutes and their use in the surgical setting.

Perhaps one of the biggest advantages of working for a biotech company, as opposed to a large pharmaceutical company, is the exposure you get to many aspects of the clinical process. As new tasks present themselves, individuals are moved around to tackle them. Having gained insight into what is required for the final clinical report, I could now also be involved in the process of helping to develop new clinical studies. In my first year at the company, I have learned what is involved in a clinical trial: everything from protocol design, recruitment of investigators and subjects, investigator meetings, the clinical monitoring process, data management, clinical research organizations, adverse event reporting, and so on. Of course, in any biotech company, there are also lots of opportunities to be involved in the preclinical basic science that is necessary to develop the therapeutic products.

Clinical writing has given me a valuable opportunity to learn not only about the writing process but also about clinical research. I have now identified areas that are of particular interest to me and have been assigned to tasks in some of these areas. Currently I am managing several off-site studies, working with researchers in different fields, to complement our clinical findings. I am still very much involved in the science process, keeping up with the literature, thinking about future experiments that need to be conducted, and analyzing previous experiments.

Now that I am on the inside, it is easy to see the many possibilities that lie ahead in industry. Whether it is moving back to basic science, or exploring different areas of clinical research, regulatory affairs, marketing, or business, a first job in clinical writing is an excellent steppingstone into industry. Of course, you may decide that you like clinical writing so much that you never want to leave it.

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