Medical writing is in 3 broad areas: promotional, educational, and regulatory. Regulatory type of writing is a niche that is highly scientific and involves making documents using particular templates and guidelines that are used to report the results of trials done clinically that are later transmitted to the US Food and Drug Administration (FDA).
Both the medium and large pharmaceutical companies like to hire medical writers that have some good regulatory experience on contract or on full-time terms to work for them. Smaller pharmaceutical and biotech companies most often go to staff recruitment agencies to look for regulatory writers on contract.
May be you are wondering what skills and qualifications you need to get a job as a medical writer in the area of regulatory niche? The very first thing you must know is that regulatory writers must be experienced in working as a data management and also with clinical operations groups that do the reviews and interpretation of clinical trial information or data.
The data is compiled, written, and edited regulatory materials which also referred to as (Investigational New Drug or IND or New Drug Application (NDA). These follow particularly clinical study reports, serious adverse event (SAE) narratives, and investigator brochures. All these documents are of very rigid nature.
These kinds of writers must also have keen knowledge of the drug-development process, FDA regulatory requirements, International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) guidelines, Good Publication Practice (GPP), that also involves knowledge of the ECTD or (electronic common technical document, that is applicable to most companies in submitting documents).
All writers must be people who are keen with detail so that the important data they handle would be safe. Even though they do not really need a specific area of degree study, they are still expected to have a background in science and experience in this line of 3 to 5 years.
Entering this field as a freelancer is not very easy because many companies need writers who have already earned many years of experience. That requires that the person who wants to make it in this field must initially work as a staff writer instead of freelance.
It is the only way they can earn experience as a staffer in a company to learn the right format and ways of writing, tips and guidance as a writer.
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