Medical Device Technical Writer

Professional Profile: Strong, team oriented writing professional.

Creative problem solver and independent thinker with the ability to work

under limited supervision. Proficient in several software programs.

. Technical Writing. Extensive experience with managing documentation

projects from the analysis and design phase through production and

delivery. Ability to organize, analyze and interpret technical and

scientific data.

. Regulatory and Compliance - Working knowledge of current FDA Regulatory

requirements. Ability to write, edit and prepare documentation in

accordance with QS/ISO, FDA, ICH Guidelines, and cGMPs.

. Communication -Proficient in Microsoft Office Suite and SharePoint.

Certified DocuTools Structured Writing User.

Professional

Experience:

July 2006- Technical Writer- Contract position- Roche Diagnostics,

Present: Process Development Group, Indianapolis, IN

Developed and created documentation packages which included

Standard Operating Procedures, User Manuals, training

documentation, pre-planning documents, customer requirement

documents, qualification documents and commissioning

documents.

Test Method Validation Team Document Coordinator. Maintained

project documentation.

Developed Periodic Review documentation packages. Results

include a total of 20 completed documentation packages over

the past two (2) years.

Interviewed and collaborated with Subject Matter Experts to

capture information necessary for the preparation of

technical documentation

Assisted in the execution of commissioning and validation

protocols which verified engineering and design

specifications compliance and cGDPs requirements.

October 2005- Technical Writer - Contract position- Pfizer Exubera Inhaled

July 2006: Insulin Packaging Line, Terre Haute, IN. Pfizer and

Rogaine/Regaine Packaging Line, Kalamazoo, MI

Developed Standard Operating Procedure (SOP) Training

Presentations. Results include a completed training package

for the Exubera Pack Line, Terre Haute, IN.

Developed and created various validation documents including

Standard Operating Policies and Procedures.

Coordinated Change Request Control process, requiring the

ability to interpret technical data.

Assisted in the execution of commissioning and validation

protocols which verified critical components of the system

were installed in accordance with applicable specifications

and cGMPs. Results include validation of the Rogaine/Regaine

Pack Line at Pfizer, Kalamazoo, MI.

April 2005- Regulatory Affairs Specialist - Contract position- Roche

September 2005: Diagnostics Corporation, Regulatory Compliance Division,

Indianapolis, IN

Processed and submitted initial and follow up FDA Medical

Device Reports (MDR). Results include closure of numerous

past due files.

Reviewed and closed potential Medical Device Reports (pMDR)

and MDR files. Reviews include interpreting and reporting on

product specific regulatory issues.

Prepared pMDR packages utilizing SAP and Access databases.

Created MDR Allegation Summaries for pro-thrombin and blood

glucose medical devices.

Professional

Experience

Continued:

February 2004 - Technical Writer - Contract position- Eli Lily Pharmaceutical

February 2005: Company, Global Clinical Data Management Division,

Indianapolis, IN

Created, authored, and edited FDA regulatory documentation.

Coordinated efforts with various Information Technology

Departments to create InForm , Clintrial and AS400 Data

Validation User Manuals for CRA team members.

Interfaced with subject matter experts to develop an

understanding of regulatory documentation.

Created Visio flow charts documenting department work flows.

Assisted with the creation of PowerPoint slide presentations

for Clintrial/AS400 software continuing education programs.

October 2003 - Technical Writer- Contract position- Eli Lilly Pharmaceutical

February 2004: Company, Delta V Project, Indianapolis, IN

Created CLASS GMP Library Audit Plan to determine format or

content changes/updates.

Performed in-depth analysis of project wrap up of CLASS Delta

V Test Execution Problem Reports.

Assisted in the development of the Test Status Overview

Report database.

Maintained database and indexes to provide tracking of Delta

V Module Test Development, Test Execution and Close Out

Status validation documentation.

Collected and reviewed Pre and Post Test Problem Reports ~

analyzed root cause findings and proposed corrective actions.

Education: Concordia University: Madison, WI B.A. Management and

Communications

GPA: 3.73 Honors: cum laude

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