Wednesday, July 18, 2012
This presentation will describe what Medical Writers write about, the document they create, additional tasks that they perform, and basic competencies needed for Medical Writers to function on the job. It will suggest ways to break into the field.
About the Speaker:
Dr. Nancy R. Katz has been a medical writer for 15 years. She is President and Principal Medical Writing Consultant of Illyria Consulting Group, Inc., which specializes in eCTD-compliant documents for regulatory submissions. Nancy holds AMWA core credential certificates in pharmaceuticals and in editing/writing; recently, she taught a course on Module 2 Summaries for the CTD at the AMWA regional convention at Asilomar. She is active member of the Medical Writing Special Interest Area Community (MW SIAC) of the Drug Information Association (DIA) and mentors writers through AuthorAid, an organization that helps researchers in developing countries publish their work. Nancy earned a Clinical Sciences Certificate from the Pharmaceutical Education Research Institute (PERI), a Certificate in Training and Human Resource Development (with distinction) from U.C. Berkeley Extension School of Business and Management, and a Ph.D. in English from U.C. Berkeley. Publications on medical/regulatory writing include: • Katz, NR. Effective eCTD Writing: Five Essential Competencies. Global Forum 2011 April; 3(2): 27-31. • Wood LF, Foster MH, Averback J, Boe P, Katz, NR. Topic-based authoring: a content management paradigm for accurate, consistent regulatory documents. Drug Information Journal. 2011 March; 45 (2): 125-129. • Katz, NR. “Your career as biopharmaceutical regulatory writer in Choosing the Right Regulatory Career (edited by Peggy Berry; RAPS; 2010). • Katz, NR. The eCTD: A primer and beyond for regulatory writers” (DIA Global Forum, April 2010.