| Medical writing can be divided into 3 broad categories: | | | | Technical Requirements for Registration of |
| regulatory, promotional, and educational. Regulatory | | | | Pharmaceuticals for Human Use (ICH) guidelines, |
| writing is a highly scientific niche that involves creating | | | | including strong familiarity with the eCTD (electronic |
| documents according to very specific templates and | | | | common technical document, used now by most |
| guidelines that report the results of clinical trials and | | | | companies to submit documents). Attention to detail |
| are ultimately submitted to the US Food and Drug | | | | is a must, since you'll be working with enormous |
| Administration (FDA). Mid- and large-size | | | | amounts of data that must be reported accurately. |
| pharmaceutical companies hire medical writers with | | | | No specific educational degree is required, but most |
| regulatory experience as contract or full-time | | | | companies look for people who have earned at least |
| employees to work on site. Smaller pharmaceutical | | | | a Bachelor's degree in a science-related field plus 3 to |
| and biotech companies often go through staffing | | | | 5 years of experience. |
| agencies and recruiters to hire regulatory writers on a | | | | Breaking into regulatory writing as a freelance can be |
| contract basis. | | | | tough, since most companies require writers to have |
| What skills do you need to excel as a medical writer | | | | several years of experience. The best way to get |
| in the regulatory niche? First and foremost, regulatory | | | | into regulatory writing is to work initially as a staff |
| writers must be adept at working with data | | | | writer rather than freelance. That way you can learn |
| management and clinical operations groups to review | | | | the company's approach and format and get tips and |
| and interpret clinical trial data. They compile, write, | | | | guidance from fellow writers in nearby cubicles. |
| and edit regulatory materials (Investigational New | | | | If you think regulatory medical writing may be for |
| Drug [IND]/New Drug Application [NDA]), with specific | | | | you, attend one of the introductory meetings hosted |
| emphasis on clinical study reports, investigator | | | | by the Regulatory Affairs Professionals Society. |
| brochures, and serious adverse event (SAE) | | | | These meetings provide a look into the "day in the |
| narratives. These documents follow very specific and | | | | life of" a regulatory writer. You can also take classes |
| rigid formats. | | | | to learn to become a regulatory writer. The |
| Regulatory writers also need a keen knowledge of | | | | University of the Sciences in Philadelphia offers a |
| the drug-development process, FDA regulatory | | | | degree program in regulatory writing. Several |
| requirements, Good Publication Practice (GPP), and | | | | colleagues have gone through this program and give |
| International Conference on Harmonisation of | | | | it high marks. |