EXPERIENCE

Manufacturing Procedure Writer

NDS Surgical Imaging, LLC, San Jose, CA; March 2011-present

  • Research, produce, publish, and maintain documentation.

  • Work with engineers and assembly technicians to observe and record NDS product assembly.

  • Capture and manipulate digital images for use in documentation and Engineering Change Order documentation.

  • Work independently to produce clear and concise manuals, Final Quality Control inspection sheets, end-user assembly instructions.

  • Prioritize and negotiate deadlines in response to a variety of clients including engineering, quality, manufacturing, and project management .


Freelance Technical Writer

Http://www.mariatom.com, Milpitas, CA; April 2009-March 2011

  • Write and edit software/hardware manuals, abridged manuals, and online training.

  • Proof and edit academic publications, scientific reports, and FDA submissions.

  • Work with documentation and change control to satisfy FDA-regulated environment.

  • Proof and edit science Ph.D. Dissertations. Format text, tables, and graphics.

  • Clients include: Vetter Pharma-Fertigung,  WHAT?! Productions, Brown University.


Contract Technical Writer

Genentech, Inc., South San Francisco, CA; March 2008-March 2009

  • Group specialist for Google applications, incl. document software with version control.

  • Create, develop, maintain documents and timelines for software and hardware for clinical and commercial manufacturing. Write summaries and justifications for doc changes.

  • Use NovaManage and TrackWise as EDMS (Electronic Data Management System).

  • Work with SMEs to negotiate timelines, gain preapproval, and route docs for approval.


Freelance Technical Writer

Http://www.mariatom.com, Providence, RI; Oct 2004-Mar 2008

  • Write and edit software/hardware manuals, abridged manuals, and online training.

  • Proof and edit academic publications, scientific reports, and FDA submissions.

  • Work with documentation and change control to satisfy FDA-regulated environment.

  • Edit text, tables, and graphics to conform to style guide (MLA, Chicago Manual, company style guide, etc.).

  • Clients include: Genentech, ETEX Corporation, OXiGENE, Inc., Mass eComm, Guidant.


Nonclinical Editor, Development Science

Genentech, Inc., South San Francisco, CA; Sept 2001-Oct 2004

  • Edit and format documents in support of regulatory submissions in a GLP setting.

  • Manage review, adjudication, audit, and signature phases of documents. Use Livelink for version control.

  • 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

Lam Research Co., Fremont, CA; Sept 2000-Sept 2001

  • Edit end-user technical manuals for semiconductor equipment, including facilities, installation, operations, maintenance, safety, SECS/GEM computer interface manuals.

  • Write, update, and edit engineering procedures. Maintain publications archive.

  • Create and write standard operating procedures for creating facilities manuals.


EDUCATION

San Francisco State University, San Francisco

M.A., English Literature, Creative Writing, Asian American Studies, 2000

Distinguished Achievement Award, College of Special Majors, 2000


University of California, Berkeley

B.A., Integrative Biology, 1997


COMPUTER SKILLS

Advanced knowledge of:

  • Microsoft Windows, Outlook, Word, Excel, PowerPoint, Office Document Imaging, Access;

  • Adobe Photoshop, Framemaker/InDesign (desktop publishing software), Acrobat (PDF software);

  • Google Gmail, Calendar, Docs, Chrome, Scholar, Book Search;

  • Mac OS, MobileMe, iLife, iWork;

  • EndNote, PubMed, Gladis.


Intermediate knowledge of:

  • Adobe PageMaker, Illustrator, RoboHelp;

  • Microsoft Visio, Project;

  • Macromedia Dreamweaver, HTML, XML coding;


Basic knowledge of:

  • C++, UNIX, Linux, Java, JavaScript, PHP, Python, Madcap Flare


Familiar with:

  • 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

  • Adherence to the FDA's Quality System Regulation (QSR), Current Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP), document version control.

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

  • Fluency in English, French, and Cantonese. Beginning knowledge of German and Mandarin.