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Lean writing is a clear and concise writing style that eliminates all unnecessary elements
(‘waste’) for the audience and keeps the message to the point. It may also be referred to
as ‘lean authoring’. The goal of lean writing is to make the document or communication
for the audience as efficient and effective as possible.
remove waste.
In the highly regulated pharmaceutical and biotech sector, the regulatory authorities
spend time and resources reviewing numerous documents prepared by companies.
These documents often describe highly complex information and huge amounts of
data. To limit the burden on the regulatory authority reviewers, it is essential to describe the
data clearly and concisely. Repetition and other unnecessary elements make the text
lengthy, difficult to read and understand, and prone to errors and inconsistencies. Text
that is longer than needed also dilutes the key message and can distract the reader.
remove waste.
The lean authoring approach is an excellent method for writing clear and concise documents. The author
should focus on what is really needed from the reader’s point of view, choose words
deliberately, construct sentences and paragraphs carefully, and present the data in the
most effective way. Everything that is not needed should be eliminated: avoid repetitive
text, use cross-references rather than a repeat of information within or across
documents, and try to cut down as much as possible.
remove waste.
This training session provides an introduction to the lean concept, followed by an explanation of the lean writing approach as well as some useful tips and tricks to help focus on your audience and to find & remove waste.