Select The Tips You Should Follow When Creating A Newsletter. Regulatory Writing – Is This Medical Writing Niche For You?

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Regulatory Writing – Is This Medical Writing Niche For You?

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

What skills do you need to excel in the regulatory field as a medical writer? First, regulatory writers must be adept at working with data management and clinical operations teams to review and interpret clinical trial data. They compose, write and edit regulatory materials (Investigational New Drug [IND]/New Drug App [NDA]), clinical study reports, investigator pamphlets, and serious adverse event (SAE) stories with particular emphasis. These documents are very specific and follow strict formats.

The authors of the regulations also discussed the drug development process, FDA regulatory requirements, Good Publishing Practices (GPP), and the International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use. Must be familiar with instructions, including medications. eCTD (electronic common technical document currently used by most companies to submit documents). Attention to detail is a must, as you will be dealing with large amounts of information that must be communicated clearly. No specific education is required, but most companies look for people with at least a bachelor’s degree in a science-related field and 3-5 years of experience.

Getting into regulatory writing as a freelancer can be difficult, as most companies require writers to have several years of experience. The best way to tackle regulatory writing is to work as a staff writer rather than a freelancer. This way, you can learn the company’s approach and format and get advice and guidance from colleagues in nearby offices.

If you think regulatory medical recording might be for you, attend one of the introductory meetings hosted by the Society of Regulatory Professionals. These meetings provide a glimpse into a “day in the life” of a regulatory writer. You can also take a class to learn how 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 rated it highly.

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