Robert Schultz

Robert Schultz

Work History

Work History
Oct 2009 - Jan 2010

Technical Writer

Fisher Clinical Services

Wrote business requirement and technical requirements for a paperless system designed to control and document the packaging of investigational drugs for clinical trials. Demonstrated technical knowledge and skill in this self-directed position.Wrote over 215 technical requirements in conjunction with IT and production management. (Contract assignment through Pierce Technical Services)

Nov 2008 - Sep 2009

Producer/Director

Scribe Video Center

Studied documentary video production.  Took courses in script writing, fund raising, camera operation, lighting, sound recording and editing.  Directed and edited a documentary about the Bronx in the 1960's.  This production won a grant from the Philadelphia Independent Video and Film Association, It was screened at the Flickering Light series at the Sedgewick Theater and at the Scribe Video Center in Philadelphia, and at the Brecht Forum in New York. Scribe named me as the their featured artist of Fall 2009.

Apr 2008 - Oct 2008

Associate I, Standards

Reviewed drafts of SOPs and associated documents for compliance with Covance corporate standard practices and ICH regulations.  Controlled distribution of documents to staff and outside clients.  Posted approved documents to Lotus Notes.
Nov 2007 - Jan 2008

Medical Document Technologist

Edited medical documents to make them submission-ready according to the requirements of the FDA and other regulatory agencies.  Prepared hyperlinks in Word and PDF renditions in conformance with Wyeth submission PDF rendering technology.(Contract assignment through On Assignment, Inc.)

May 2007 - Oct 2007

Document Management Specialist

Performed QA review of over 40 Technical Recovery Guides (TRGs) required to perform disaster recovery of IT software.Used GXPharma to created new TRGs and coordinated their workflow.Reformatted existing TRGs into a new format requiting additional data. Researched documentation cited in the TRGs to ensure tractability and auditability.Used Remedy to track the work effort.(Contract assignment through Matlen Silver, Inc.)

Mar 2007 - May 2007

Technical Writer

Wrote SOPs and change control document for a GxP regulated Remedy instance.Managed system lifecycle documents in a Documentum application.Set up software tests in Mercury TestDirector. (Contract assignment through Judge Technical.)

Sep 2006 - Dec 2006

Technical Writer

Wrote and edited Standard Operating Procedures (SOPs) and Local Instructions (LINs) for the Desktop Technology Services group in preparation for a security audit.Analyzed existing GSK regulatory documents to extract pertinent information for use in new regulatory documents.Wrote validation scripts for testing of new COTS software to ensure compliance with FDA regulations.(Contract position through Tek, Inc.)

Apr 2006 - Sep 2006

Technical Consultant

Wrote and edited SOPs and Best Practices and for the Global Biometric Sciences department in support of the EmBARC project to standardize validation of clinical programming.Collected and analyzed reviewer comments on draft documents.Customized document templates to ensure uniform document design and formatting. (Contract Position through Shared Computer Resources.)

May 1993 - Dec 2005

Documentum Support Engineer (2001-2005)

 Supported users of the Electronic Document Management System (EDMS). A Documentum-based hypertext docbase containing over 7 million documents accessible by over 8,200 users worldwide.

  • Developed an extensive understanding of pharmaceutical development processes and regulatory submission practices.
  • Provided 2nd and 3rd tier support to resolve user problems requiring highly technical intervention including use of DQL and the Documentum API.
  • Supported two GXPharma instances.  Analyzed and corrected clinical trial document workflow.
  • Used various Adobe tools to produce and maintain effective versions of docbase documents.
  • Drafted Work Instructions and Memos that document support procedures.
  • Wrote SOPs and system documentation required by federal and international regulatory agencies.
  • Wrote Functional Requirement Specifications, User Design Documents, Requirements Traceability Matrices, and Best Practices.
  • Wrote validation scripts used in validation testing to ensure system compliance.
  • Completed Documentum 5 administrator training conducted by Documentum.

 Usability Project Manager (2000-2001)

 Proposer and Project Manager of the EDMS Usability Project designed to evaluate and improve user experience of the Wyeth Electronic Document Management System (EDMS):

  • Coordinated and facilitated bi-weekly usability committee meetings, involving Director level staff from Information Management and Information Systems.
  • Prepared worldwide on-line survey that was completed by 667 of the 5300 registered users.
  • Co-facilitated 10 worldwide focus groups, using an electronic meeting facilitation system.
  • Analyzed the usability survey and focus group data and created a coherent final summary report.

 Technical Writer (1993-2000)

Wrote Documentation for custom software developed by the in the Wyeth Research IT group:

  • Wrote over 15 on-line Help systems, and over 7 user manuals. Developed single source printed and on-line documents. Ensured users could operate complex custom software in a research environment.
  • Maintained documents with updates and revisions. Authored on-line Help using Doc-To-Help, RoboHelp, and CorelDraw.
  • Wrote portions of System Development Methodology as well as SOPs for IS group.
  • Performed internal audit of development cycle documentation for Application Development applications.
  • Managed the web pages for the Technical Communications Section of Research IS.

Education

Education

B.A.

Fordham University

M.A.

City University of New York

Degree from Richmond College (now College of Staten Island), CUNY, Staten Island, NY

English Major, thesis in Linguistics

Summary

Senior technical writer with extensive experience creating manuals used by technical and non-technical groups in the pharmaceutical and computer industries. Designed and developed user and system documentation as well as online Help systems for windows- and web-based single source technologies. Detail oriented, highly organized individual who works well independently and as part of a team. Experienced systems trainer and lecturer in technical writing instruction at university level. Extensive knowledge of: Documentum, Document Management Systems, Hypertext, Information Technology, Electronic Imaging, and Process Control. Experienced authoring and QA reviewing of validation scripts and reports as well as regulatory documentation

Training and Instruction

Taught technical writing to undergraduate and graduate students at: Arcadia University, Drexel University, and Temple University.

Technical Skills

Extensive knowledge of Documentum 4i, Documentum 5, GXPharma, HTML, Adobe, RoboHelp, Doc-To-Help, Visual Basic 6, MS Windows, UNIX, VMS, GroupSystems, MS Word, MS PowerPoint, MS Project, MS Visio, MS Excel, WordPerfect, CorelDraw, Peregrine ServiceCenter, Lotus Notes, Final Cut Pro. Mercury TestDirector, Remedy