Rare ability to bridge the worlds of technology, data standards, content management, clinical development, and regulatory submissions.
Over 15 years experience with software, technology, and writing activities, including authoring, collaboration, knowledge management, submission process, and document lifecycle.
• MW Team Lead for Content Management at Shire
• Sanofi Clinical Documentation Program Manager for CRUISE, a cutting edge software development and process improvement project based on a Structured Content Management platform
• 1st Place Team, 2014 Sanofi R&D Award for Operational Excellence
• Directed Genzyme Medical Writing Group for Rare Disease for 8 years
• Extensive experience with regulatory documents, publication writing
• Member of DIA EDM Reference Model Working Group
• Worked with FDA on HL7 Clinical Study Design Structured Document
• Trained on CDISC Clinical Data Standards
• Agile Software Development experience
• Genzyme Medical Writing lead for Document Lifecycle initiative, an innovative software development project for clinical submission preparation
• Founded Medical Writing Department at Millennium Pharmaceuticals, developed standards, processes, SOPs, templates for Clinical Study Reports, Clinical Study Protocols, Clinical Development Plans and other documents; implemented processes for authoring, review and publishing.
• Clinical lead for development and implementation of Millennium’s first document management system, mDoc (documentum-based)
• Key role in developing end to end process for Genzyme disease registries reporting.
• Strong technology background (BS in Electrical Engineering, Cornell Univ);
• Extensive management experience (Millennium, Genzyme, Sanofi)
• Experienced Medical Writer (multiple therapeutic areas, protocol development, submission documents, narratives)
• Strong medical science background (MS in Applied Anatomy and Physiology, Boston Univ; PhD in Medical Science,Brown Univ)