Tuesday, March 29, 2011

Tips To Excel As A Regulatory Writer

By Robert J. Walker

The three main areas of medical writing are: promotional, educational and regulatory. Basically the niche in regulatory writing is the one that is stringently scientific in that it uses very specific templates and guidelines to do its documents. They are applied in making reports for the results of clinical trials as specified under the FDA, or rather the Food and Drug Administration of the USA.

Both the big and medium companies that deal with pharmaceutical products always use writers that are experienced in regulatory writing. They hire them on full-time or contract basis to do this work. The medium or smaller companies seem to prefer going to the staff recruitment agencies to hire the regulatory writers whom they can hire on contract.

In the area of regulatory writing one should know how to deal with data management, clinical operations as well as reviewing and interpretation of all information plus data used in clinical trials.

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).

The writers must be meticulous, people with an eye for detail since they use a lot of important data in their writing. Although they do not need to be qualified with a degree in any specific field of study, but you will find most companies insisting that one should have a scientific background and a 3 to 5 year on the job experience.

It is the reason why it is never very easy to start in this career as a freelancer because most companies just take those with experience and this requires that one must understudy somebody else as a staff writer.

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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