Books and Published Works
Writing for the Biopharmaceutical Regulatory Reader Second Edition
Just Published
Cover image for Second Edition
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This second edition offers expanded guidance for writers and reviewers of biopharmaceutical documentation. Our book is designed to help improve regulatory writing for research reports, briefing books, regulatory responses, and drug marketing applications. We constructed this book to help you anticipate regulatory reader’s needs, enhance communication clarity, and apply lean writing principles to strengthen every level of communication quality—from sentences, to paragraphs, to entire documents.
We have added new chapters addressing the concepts of lean writing and writing actions to optimize communication quality for many types of regulatory documents. Everyone seeks to make writing clear, and one sure route to clarity is writing no more words than necessary. When writing is lean, when it employs the fewest words possible to the greatest effect, communication becomes more efficient and emphatic. We offer an expanded set of actions for summary and advisory documents, intended to be useful in all forms of research and regulatory documents. |
...Don’t let the specific title fool you; while geared towards a biopharmaceutical audience, this text also has plenty of relevance for multiple technical audiences...
Rooted in research insights regarding the psychology of decision-making, reading behaviors, and complex information design, this text offers clear, logical, and practical guidance to allow writers to successfully meet the needs of multiple purposes and audiences. Within each chapter Cuppan and Bernhardt draw from their extensive experience consulting in the biopharmaceutical industry to provide successful writing strategies. These strategies span from careful analysis of audience and situation of use to macro-level concepts of information design, all the way through micro elements such as sentence-level style. Throughout Writing for the Biopharmaceutical Regulatory Reader, the authors include multiple exemplary and faulty examples to effectively illustrate each of the concepts they present. ~ Amazon Customer Review for the First Edition
Writing for the Biopharmaceutical Regulatory Reader
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This book provides guidance for beginning and advanced authors, as well as reviewers, of biopharmaceutical documentation.
Written by Greg Cuppan and Stephen Bernhardt, the book is intended for those who wish to improve their ability to contribute to high-quality regulatory writing. Whether it is a briefing book, responses to regulatory inquiries, or marketing authorization packages, this book will help you think more productively about regulatory readers, how they use what you have written, and how to accomplish more within a paragraph, section, an entire document, or a complex dossier. Over the past 30 years, we have had the opportunity to formally evaluate how readers engage with submission documents. These interactions have helped us to refine our understanding of the decision-making behavior of the regulatory reader. In this book, we explore the kinds of questions many writers face on a routine basis:
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This book is filled with valuable context and practical, immediately applicable writing advice for medical writers. I’ve been in the industry almost 10 years and am always looking for ways to sharpen my messaging skills. Bernhardt and Cuppan give a deep dive into the reviewer mindset of document use, walk you through overarching organization principals, and end with a handy sentence-level primer on good scientific writing. Best of all are the numerous examples and commentary on each one, turning abstract concepts into clear demonstrations. If you’re a medical writer, definitely pick up this book! ~ Amazon Customer Review
Learn More:
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Why did we create the book?
"The fact is that people in industrial settings often don't get help with their writing...There's a gap between a college classroom and a work setting." |
Document Design
"Information design is essential to the success of all regulatory writing projects...We have to create a document the reader can use." |
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What makes regulatory writing different from other scientific writing?
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What makes this book different?
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Coming Soon:
Greg and Stephen are working on a book for chemists, specifically those who work to assure quality in CMC (chemistry, manufacturing, control).
