Quality Clinical

**** ******* ***.

Bettendorf, IA *****

Phone: 563-***-****

Email: *************@*****.***

Roberto Young

Objective:

To secure an entry level position as an Electrical Systems Technician where I can utilize my skills in order to advance with the changing technology.

Skills:

Troubleshooting and building circuits

Knowledge of reading schematics

Proficient in computer concepts and applications (hardware and software)

Assembly of electronic devices such as AM/FM radio receivers, volt meters and power supplies

Proficient in Word, Excel, Access and Power Point

Knowledge of PLC's: Shark, Toshiba, SLC 500, MicroLogix 1200

Writing Ladder Diagrams

CNC Lathe and Mill

FANUC Robot

Documentum, Core Dossier, Adobe Acrobat

Education:

2/2009 – 12/2010 Hamilton Technical College

Associate of Science in Electronic Engineering Technology

12/1997 – 5/1998 The Chubb Institute

Diploma: Data Center Support

2/1997 – 8/1997 Central Career School

Certificate: PC Office System Specialist

Work

History:

6/2008 – 11/2008 Celgene

Clinical Document Processor

Used word processing and related software applications to produce high quality clinical documents from handwritten copy, typed copy, and/or electronically scanned copy in a centralized word processing environment.

Clinical documents included, but are not limited to protocols, amendments, clinical study reports, briefing books, clinical summaries, clinical section of INDs, and investigator’s brochures.

Edits, reviews, and proofreads copy for proper grammar, sentence structure, spelling, and punctuation, and format according to specified style and formatting guidelines including the Celgne Style Guide.

Ensured clinical documents adhere to global standards and are in accordance with electronic publishing standards.

4/2001 – 5/2008 PRD (A Johnson and Johnson Company)

Dossier Analyst, Document Specialist, Routine Publisher, Word Processor

Published, QC’d, and indexed taskes for all submissions that were handled for Global Regulatory Affairs

Supported submissions such as Annual Reports, IND Amendments, General Correspondence and Electronic Advertising submissions.

Created and QC’d bookmarks, links and hypertext links.

Paper submissions were quality checked to ensure that all pieces were present in the prescribed order, special pages were present, and tab text matches the content plan.

Core Dossier publishing

Created and published dossiers for submission using the current suite of tools. (Core Dossier)

Performed quality checks on all submissions using the Quality Check process checklist.

Utilized Grips, which manages document creation & publication through a shared database.

Worked closely with Medical Writers on clinical documents.

Formatted and edited documents in Grips (Global Research Information & Publishing System)

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