Technical Writing for the Pharma, Device and Biotech Industries
Technical writing for the IT industry is quite different from technical writing for the pharma, device and biotech industries. Technical writing for the pharma, device and biotech industries is a combination of skills and science. On the one hand, it requires extensive knowledge required from these vast and diverse, albeit related industries. On the other, it requires good language skills to present on paper what would otherwise constitute dull and prosaic writing that the common reader would likely find quite obtuse.
Understand the audience
Technical writing for the pharma, device and biotech industries involves first of all, knowing whom the writing is being done for. This is the foremost requirement, because the level of jargon or depth of the subject that goes into technical writing for the pharma, device and biotech industries is directly proportionate to the level of knowledge the audience has of the subject. If the audience is a professional or academic with high credentials, it is necessary to shape the writing to suit them. Likewise, it is advisable to remain simple and effective and rid the writing of its high sounding cant if it is for a lesser audience.
Understand the minds of regulatory bodies
A professional doing technical writing for the pharma, device and biotech industries needs to have a grasp of the intricacies that documentation for regulatory bodies expect and require. The FDA, Eudralex, the ISO and other such bodies require their own standards, so it is necessary for those doing technical writing for the pharma, device and biotech industries to be aware of these.
Understand for whom the writing is being done
Anyone doing technical writing for the pharma, device and biotech industries has to be aware of the market for which the writing is being done. They should understand the role and importance their writing plays with the eventual user. There should be clear understanding of whether technical writing done for the pharma, device and biotech industries is going to be used for higher research, for understanding the market better, or for understanding the competitor, and so on.
Understand the nitty gritty of the industryAlso, when doing technical writing for the pharma, device and biotech industries; the writer has to have a good grasp of the technicalities of the industries. Terms in these industries are filled with many hairsplitting definitions and specifications. The writer doing technical writing for the pharma, device and biotech industries has to be completely aware of the differences between each of these. It is only when these fundamentals among others are grasped that writing becomes successful and effective. The ability to also revise and edit what is written should be built into technical writing skills for the pharma, device and biotech industries.
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Labels: medical device regulations, Process Validation Guidance for Medical Device, Process Validation in Medical Devices, Validation and Verification for Medical Devices
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