Compliance and Writing Services for the Life Sciences Industry

Mitch Gordon has been a professional writer for 16 years. He is finishing his Masters degree in Regulatory Affairs, to be completed in late 2010. His specialties are regulatory and quality system compliance, clinical documentation, and medical writing.

Summary of Education and Experience

Quality and Regulatory Manager at Life Enhancement Products, Inc. Responsible for bringing the company compliant with FDA GMP (Good Manufacturing Practices) by mid-2010.
M.S. degree in Regulatory Affairs nearing completion (coursework done, thesis in progress). B.A. in Biology.
Three years of experience as a technical writer for a biotech instruments startup, responsible for creating application notes, journal articles, conference posters, technology overviews, technical manuals, marketing collateral, slideshows, SOPs, training materials and electronic media.
Thirteen years of experience as a technical writing contractor in the software and other industries, writing highly technical as well as end-user-oriented books and courseware.

Specialties

Regulatory and Clinical Documents: Detailed understanding of FDA and EU drug and medical device regulations. Will participate in project teams to develop preclinical reports, clinical study protocols, integrated summaries, investigator brochures (IBs). clinical sections of CTDs, clinical trial registry summaries, IND and NDA annual reports, patient narratives. clinical study reports (CSRs), Familiar with eCTD creation and submission process.
Technical Writing: Instructional and reference books, SOPs, marketing collateral, training courseware, white papers, conference posters, electronic media, cowriter of published articles with technical colleagues.
Medical Terminology: Broad knowledge of biological processes and terminology.
Editing: All levels, from proofreading and copy editing through substantive rewrites.
Data Mining, Biostatistics and Reporting.
Desktop Publishing and Graphic Artwork: Photoshop, Illustrator, HTML, online help, video, Flash animations, SEO, email blasts.