Describing writing actions in biopharmaceutical regulatory submission documents

originally posted to LinkedIn July 2023

Been a bit since I’ve posted an article here on LinkedIn. My wheels are still turning on thoughts about writing in the biopharmaceutical space. Perhaps the wheels are turning just a little slower. But, at least the wheels still turn!!

Purpose of this article is to share some thoughts on writing actions that should happen within biopharmaceutical research reports and keystone regulatory submission documents. These are the actions that enable a document to be considered a high-quality communication platform. For each action, I present the associated parameter that describes the action.

Please take 5 minutes to read through this list and if you have further time, please share your comments on the merits of what I have compiled as descriptors of writing actions.

Analyze

• Take apart some complex factor/phenomenon to understand the important elements, identify dependencies, establish trends, or make predictions.

Argue

• Take a position or make a claim and support it with data, evidence, and logical reasoning.

Assess

• Form a judgment based on evidence as to whether an interpretation or action is logically justified.

Compare

• Discuss two or more elements of information to assess the degree of agreement or disagreement in their design, execution, or results.

Be concise

• Communicate efficiently, avoiding unnecessary repetition, wordiness, or ambiguity.

Critically analyze

• Discuss strengths and weaknesses of current understanding, taking positions on the reliability, strength, limitations, and quality of the supporting data. A critical analysis might systematically assess an explanation, theory, argument, data set, study, or comprehensive set of studies.

Describe

• Identify key features, qualities, actions, and decision-making so a reader has a good understanding of what was done and why.

Discuss

• Argue for what is most important or relevant to the case at hand, highlighting strengths and weaknesses, addressing counter arguments, or presenting alternative interpretations.

Evaluate

• Assess the quality of data based on adequate study design, study execution, robustness or consistency of findings, reliability, usefulness, significance, or relevance to real world application.

Integrate

• Compare results from two or more research studies to discuss common or divergent patterns in the data.

Interpret

• Form a position on how to understand research results based on statistical and logical analysis.

Narrate

• Comment on important understandings regarding conduct of research and output of research. Narration might focus on critical data points, specific cases, outliers, expected or unexpected findings, or unexplained results.

Overview

• Provide a high-level introduction to document content at the section and subsection to help a reader orient to the most important understandings. Overviews establish purpose, scope, and sequence for a section or subsection.

Rationalize

• State the logic motivating interpretations, decisions, or actions.

Summarize

• Present findings in a discrete manner with a focus main points, key arguments, and significant data.

Synthesize

• Pull together information from various sources to integrate into a comprehensive whole. Draw connections between ideas, and communicate complex information in a clear and coherent manner to build a logical argument or to establish a new conceptual understanding.