Medical writing is a functional area which is tasked with production of key documents for the R&D organization including study protocols, statistical analysis plans, clinical study reports, investigator’s brochures, and briefing documents. These documents are often necessary for certain regulatory submissions and follow strict organizational structures. The International Conference of Harmonization (ICH) is the common standard used in many of these documents as it is accepted by authorities in the European Union, Japan, and the United States.

Medical writers work with cross-functional groups including clinical development, biostatistics, pharmacokinetics, regulatory strategy, and others to align to the language in these documents before finalization.