Experience

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  Genentech

  • South San Francisco, California

  • Sr Manager, Nonclinical Submission Support

    • Jan 2017 - Present
    • South San Francisco, California

    Responsible for managing a team of contract and staff editors and for ensuring smooth editorial operations to deliver nonclinical documents such as study reports and summary sections in support of regulatory filings including INDs, BLAs, and NDAs. Currently working on a number of departmental and corporate initiatives to improve and streamline filing processes.

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  Bulletproof Documentation, Inc.

  • Burlingame, CA

  • Quality & Regulatory Tech Writing Consultant

    • Nov 2013 - Dec 2016
    • Burlingame, CA

    Coherus Biosciences (Jan through Dec 2016) Project manager/'pinch hitter' for Regulatory Affairs functions including medical and CMC writing and Reg Ops. Scheduled work for contract writers. Created a comprehensive writing style and formatting guide. Editing, formatting, and checking the final data (QC) on MAA submissions. Handled document reviews and adjudication. Held kick-off meetings for multiple-document projects. Set up internal procedures. Facilitated translation as needed.Complete Genomics (Oct to Dec 2015)SOP technical writer for the Revolocity genome sequencer.Genentech (Jan to Oct 2015)Compiled Annual Product Quality Review (APR/QPR) reports for marketed products. Collaborated with staff across departments to gather source information. Made use of TrackWise EQMS software to document CAPA progress. Adjudicated reviewer feedback and edited APR/QPR reports from other authors. Collaborated with department leadership to create work processes and author work instructions for report authors. Revised wording and layout to significantly improve APR/QPR report templates.

• 

  Thermo Fisher Scientific

  • Sr Manager, Information Development

    • 2005 - 2011

    Responsible for the Information Development department. Managed a staff of 30+ writers, editors, illustrators, and front-line managers. Managed a $4M annual budget. Created and drove departmental initiatives to meet corporate imperatives.

  • Manager, Information Development

    • 2001 - 2005

    Actively managed the performance of technical writers and editors. Successfullymanaged multiple simultaneous documentation projects.

  • Sr Technical Writer

    • 1997 - 2001

    Edited and wrote end-user product instructions for software, hardware, and consumable kits for the life science industry. Managed multiple simultaneous documentation projects.

• 

  Genentech

  • Staff Technical Editor, QA Documentation / Master Change Control

    • 1991 - 1997

    Created and edited manufacturing documents in GMP and GLP environment. Quality Assurance project management.