Medical writing can be divided into 3 broad categories: regulatory, promotional, and educational. Regulatory writing is a highly scientific niche that involves the creation of 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). Medium and large pharmaceutical companies hire medical writers with regulatory experience as contract or full-time employees to work on-site. Smaller pharmaceutical and biotech companies often use staffing agencies and recruiters to hire contract regulatory writers.
What skills do you need to excel as a medical writer in the regulatory niche? First, regulatory writers must be adept at working with clinical operations and data management groups to review and interpret clinical trial data. They collect, write and edit regulatory materials (Investigational New Drug [IND]/Application for New Medication [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 thorough understanding of the drug development process, FDA regulatory requirements, Good Publication Practices (GPP), and the guidelines of the International Conference on Harmonization of Technical Requirements for Pharmaceutical Product Registration for Human Use (ICH), including great familiarity with eCTDs (Electronic Common Technical Document, now used by most companies to submit documents). Attention to detail is a must as you will be working with huge amounts of data that must be accurately reported. No specific educational degree is required, but most companies are looking for people who have earned at least a bachelor’s degree in a science-related field plus 3-5 years of experience.
Breaking into regulatory writing as a freelancer can be difficult, as most companies require drafters to have several years of experience. The best way to get started in regulatory writing is to initially work as a staff drafter rather than freelance. That way, you can learn about the company’s approach and format, and get advice and guidance from other writers in cubicles nearby.
If you think medical regulatory writing 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 normative writer. You can also take classes 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 been through this program and give it high marks.
