Regulatory Writing – Is This Medical Writing Niche For You?

Nancy B. Alston

Medical writing can be divided into 3 broad categories: regulatory, promotional, and educational. Regulatory writing is a highly scientific niche that involves creating documents according to very specific templates and guidelines that report the results of clinical trials and are ultimately submitted to the US Food and Drug Administration (FDA). Mid- and large-size pharmaceutical companies hire medical writers with regulatory experience as contract or full-time employees to work on site. Smaller pharmaceutical and biotech companies often go through staffing agencies and recruiters to hire regulatory writers on a contract basis.

What skills do you need to excel as a medical writer in the regulatory niche? First and foremost, regulatory writers must be adept at working with data management and clinical operations groups to review and interpret clinical trial data. They compile, write, and edit regulatory materials (Investigational New Drug [IND]/New Drug Application [NDA]), with specific emphasis on clinical study reports, investigator brochures, and serious adverse event (SAE) narratives. These documents follow very specific and rigid formats.

Regulatory writers also need a keen knowledge of the drug-development process, FDA regulatory requirements, Good Publication Practice (GPP), and International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines, including strong familiarity with the eCTD (electronic common technical document, used now by most companies to submit documents). Attention to detail is a must, since you’ll be working with enormous amounts of data that must be reported accurately. No specific educational degree is required, but most companies look for people who have earned at least a Bachelor’s degree in a science-related field plus 3 to 5 years of experience.

Breaking into regulatory writing as a freelance can be tough, since most companies require writers to have several years of experience. The best way to get into regulatory writing is to work initially as a staff writer rather than freelance. That way you can learn the company’s approach and format and get tips and guidance from fellow writers in nearby cubicles.

If you think regulatory medical writing may be for you, attend one of the introductory meetings hosted by the Regulatory Affairs Professionals Society. These meetings provide a look into the “day in the life of” a regulatory writer. You can also take classes to learn to become a regulatory writer. The University of the Sciences in Philadelphia offers a degree program in regulatory writing. Several colleagues have gone through this program and give it high marks.

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