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The challenges of writing regulatory documents: a survey of medical writers

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Summary

A 12-part survey was performed of 446 medical writing professionals in pharmaceutical companies in order to discover the major causes of delay in completing a regulatory submission, the most difficult steps in the process and the biggest hurdles for novice writers. Responses were received from 39 medical writers in 31 companies. Last-minute revisions and late-breaking study results were the main causes of delays. Managing a multi-country dossier was the most difficult step and maintaining consistency across disciplines and documents was the second. Novice writers had difficulty seeing the big picture of the whole submission and were unfamiliar with document structure and content.

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Acknowledgment

The authors gratefully acknowledge the medical writers in pharmaceutical companies, CROs and consulting companies who took the time to respond to the questionnaire. They also thank Suzanne Wampler for her help with analyzing the data and Kathy Nomides for her help in developing the questionnaire.

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Authors and Affiliations

  1. DataEdge, LLC, 500, Office Center Drive, Suite 200, Fort Washington, PA, 19034, USA

    R. Benamar (Manager) & M. Hovde

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  1. R. Benamar
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  2. M. Hovde
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Benamar, R., Hovde, M. The challenges of writing regulatory documents: a survey of medical writers. International Journal of Pharmaceutical Medicine 14, 265–269 (2000). https://doi.org/10.2165/00124363-200010000-00012

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  • DOI: https://doi.org/10.2165/00124363-200010000-00012

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