Maria F. Tom - Writer

EXPERIENCE

Freelance Writer and Literary Agent(July 2010-present)

Self-employed, Milpitas, CA
  • Proof and edit Ph.D. Dissertations. Format text, tables, and graphics.
  • Full range of literary services, including but not limited to page-by-page editing, manuscript critique, book design, and author representation 

Contract Technical Writer (Mar 2008-Mar 2009)

Genentech, Inc., South San Francisco, CA

  • Use NovaManage and TrackWise as EDMS (Electronic Data Management System).
  • Create, develop, maintain documents and timelines for clinical and commercial manufacturing. Aid with summaries and justifications for intended doc changes.
  • Work with SMEs to negotiate timelines, gain preapproval, and route docs for approval.
  • Group specialist for Google applications, incl. document software with version control.

Freelance Writer (Oct 2004-present)

Self-employed, Providence, RI

  • Write and edit user manuals (software and hardware), abridged manuals, and online help.
  • Proof and edit academic publications, scientific reports, and FDA submissions.
  • Work with documentation and change control to satisfy FDA regulated GXP environment.
  • Edit text to conform to style guide (MLA, Chicago Manual, company style guide, etc.).
  • Format text, tables, and graphs to company standards.
  • Create research library and literature request and archival procedure.
  • Prepare PowerPoint presentations for training.
  • Clients include: Genentech, Inc., ETEX Corporation, OXiGENE, Inc., Mass eComm, Guidant.

Nonclinical Editor, Development Sciences (Sep 2001-Oct 2004)

Genentech, Inc., South San Francisco, CA

  • Edit and format documents in support of regulatory submissions in a GLP setting.
  • Manage review, adjudication, audit, and signature phases of documents.
  • Assist in preparation of nonclinical section of CTD, BLA, and IND submissions.
  • Submit documents and electronic files to Regulatory Affairs and corporate archive.

Technical Writer, Publications Department (Sep 2000-Sep 2001)

Lam Research Corporation, Fremont, CA

  • Edit end-user technical manuals for semiconductor equipment, including facilities, installation, operations, maintenance, safety, and SECS/GEM computer interface manuals.
  • Write, update, and edit engineering procedures. Maintain publications archive.
  • Create and write standard operating procedures for creating facilities manuals.
  • Write operations and maintenance manuals for an entirely new product.
  • Maintain computer simulator for Alliance software.  

EDUCATION

San Francisco State University
M.A. in English Literature, Creative Writing, Asian American Studies, 2000.

University of California, Berkeley
B.A. in Integrative Biology, 1997.

COMPUTER SKILLS

Advanced knowledge of:

  • Microsoft Windows
  • Microsoft Outlook
  • Microsoft Word
  • Microsoft Excel
  • Microsoft Access
  • Microsoft PowerPoint
  • Microsoft Office Document Imaging
  • Adobe Acrobat
  • Adobe Photoshop
  • Adobe FrameMaker
  • EndNote
  • PubMed

Intermediate knowledge of:

  • Adobe PageMaker
  • Adobe Illustrator
  • Adobe RoboHelp
  • Macromedia Dreamweaver
  • HTML, XML coding
  • Corel Ventura
  • Macintosh OS

ADDITIONAL SKILLS

Familiarity with the Following Style Guides

  • Chicago Manual of Style
  • American Medical Association (AMA) Manual of Style
  • Scientific Style and Format, Council of Science Editors (CSE)
  • Modern Language Association (MLA) Style Manual
  • The Elements of Style by Strunk and White
  • Microsoft Manual of Style for Technical Publications

FDA training

  • FDA's Quality System Regulation (QSR)
  • Current Good Manufacturing Practices (cGMP)
  • Good Laboratory Practices (GLP).

Personal skills

  • Managing and prioritizing several projects at once
  • Coaxing information and review material from Subject Matter Experts (SME) in order to meet deadlines
  • Working with non-native English speakers.