Many companies have style guides that span over 100 pages and cover everything from the fine points of template use to the details of punctuation preferences. While having these documents is a sign of a well-organized writing group, a smaller, project-specific style sheet of two to 10 pages can be used on large projects that call for cross-departmental work and/or the help of contractors. This miniature version of the style guide can bring disparate groups of writers up to speed quickly and ensure that the most important aspects of the company’s writing style are consistent throughout its documentation. Perhaps most importantly, the critical aspects of template use can be emphasized in this short format to ensure efficient publication of electronic submissions.

In this audio conference, our speaker provides tips and insight on developing and managing the use of short style guides, and how best to use them to improve the quality of your regulatory submissions.

This audio conference covers:

• When to use a short style sheet
• What to include in a project-specific short style sheet
• Helpful writing conventions for use with electronic submissions documents
• How to update the short style sheet so that it remains current

About the speaker:

Dr. Susan Coleman Sisk, RAC, has 15+ years of experience in designing, writing, and reviewing medical and regulatory documents for pharmaceuticals, biologics, devices, and combination healthcare products. After starting her pharmaceutical career in genetic toxicology, she decided to combine her ability to analyze data with her aptitude for clearly communicating complex scientific results, and she became a medical writer at ClinTrials Research. There she managed large, multidocument writing projects and performed regulatory tasks for study startups and submissions. She was promoted to Associate Director of Regulatory Affairs and provided regulatory services in this role and as a Senior Regulatory Scientist at Ingenix.

In 2001, she joined Schwarz Biosciences as a regulatory project leader and FDA liaison, then helped start and build a high-performance medical writing group, including setting up company infrastructure such as standard operating procedures, regulatory document guidance and templates, writing conventions, and quality control specifications. Her work included process management and preparation of marketing applications for FDA and European Union Competent Authorities, using the CTD format for both paper and electronic submissions.

In early 2006, she founded SFP Consulting, LLC, a company providing medical writing services and regulatory submissions project management to support development of healthcare products. Dr. Sisk also provides training, including instruction and practice on preparing regulatory submission documents (especially those in the CTD) and process optimization.

Who should attend?

• Preclinical Writers
• Preclinical Scientists
• Medical Writers
• Directors, Medical Writing
• Managers, Medical Writing
• Clinical Research Scientists
• Directors, Regulatory Affairs
• Managers, Regulatory Affairs
• Project Managers