Contract writers, whether freelancers or CRO personnel, can be an important extension of medical writing resources during planned workload peaks or when unexpected writing projects arise.

This audio conference presentation is designed to provide sponsors with information on how to get the best product from a contract writer, and to show contractors how to ensure they produce materials that meet sponsors’ expectations.

Our speaker provides attendees with practical recommendations and case studies of successful collaborations, and emphasizes the process of report writing – including preparation of a shell report prior to availability of final data displays, and other activities that can maximize sponsor input and minimize the timeline after database lock.

This audio conference covers:

• Characteristics a sponsor should look for in a contract writer or writing group
• Information to include in requests for proposals
• Best types of work to outsource in different situations
• How to maximize sponsor input and minimize the timeline after database lock
• Key role of communication between all parties in the relationship

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. Dr. Sisk is also an authorized facilitator for the MeduMAZE Drug Development and Approval Game. This board game, when combined with a didactic component, brings the medicine development process (from early nonclinical testing through government approval and marketing) to life and teaches the importance of good science and planning in a relaxed and enjoyable way.

Who should attend?

• Clinical Operations
• Medical Writers
• Directors, Medical Writing
• Managers, Medical Writing
• Drug Safety Officers
• Regulatory Affairs Managers