Ngo Thian Pau

**** ******* ***, ******, ** ***** – 301-***-**** - adwqbs@r.postjobfree.com

Summary of Qualifications

Specializing in Data entry with more than 10 years of experience leading, planning, and executing document management and systems operations ranging from corporate enterprise to large government organizations. Management recognized as a competent decision-maker with the keen ability to identify, analyze, and minimize data entry related operations issues. Exceptional interpersonal and analytical expertise with a passion for increasing organizational cohesiveness and profitability by aligning data entry intiaitves to execute on company goals and objectives successfully.

Signature Skills

Customer Service, Leadership & Team Building, Process Improvement, Project Management, Document Management, System Documentation, Cross-Functional Communication. Regulatory Guidelines, UNIX ? C++, Microsoft Windows 7 – 10, Microsoft Office, Fluent in Chin and Burmese; Proficient in Malay

Professional Experience

Computer Operator II – CDER Electronic Document Room 12/2015 – Present Zimmerman Associates Inc. Silver Spring,MD 40 Hours/Week Contractor for the United States Food and Drug Administration

• Process eCTD and non-eCTD physical/electronic and mixed submissions associated with Investigational New Drug (IND), Drug Master File (DMF), and New Drug Application (NDA)

• Abbreviate New Drug Application (ANDA), and Biologics License Application (BLA) by inserting CD or Dvd into CD-Room and by transferring its contents to Staging (Back-up) Server and Production Server respectively.

• Plan IT Project Management to provide proper program business alignment; create charters, project plans, and tracks key milestones.

• Upload more than 70 submissions per day including eCTD and non-eCTD physical/electronic and mixed IND, DMF, NDA, ANDA, and BLA submissions from Office of Prescription Drug Promotion (OPDP).

• Send out e-mail notifications to recipients including but not limited to the Regulatory Health Project Managers and other FDA reviewers via Document Archiving Reporting and Regulatory Tracking System (DARRTS).

• Prepare and send out emails in line with electronic submission guidelines for the Center for Drug Evaluation and Research (CDER) regarding rejection submissions to sponsors.

• Receive incoming boxes containing scanned jackets from BCPI and check out outgoing boxes to BCPI twice weekly.

• Upload digitized or scanned pdf files, which were retrieved from Network Shared Folder and transferred to the BCPI Production Server; send out emails to relevant staff members when submissions are completed and ready for pick-up.

• Make corrections when needed regarding application numbers, INVAS numbers, and supporting document numbers associated with scanned NDA, ANDA, and BLA submissions from OPDP.

• Keep records of document corrections made in tracking spreadsheets accordingly.

• Upload files associated with bad ad complaints and surveillance electronic materials to Production Server upon receipt of email request from OPDP.

• Replace files associated with NDA, ANDA and BLA submissions upon receipt of request via email or Cd/Dvd by renaming respective files.

• Process gateway submissions in EDR queue by entering core ID number, copying and pasting the eCTD folder and its contents from Production server to new windows explorer screen, switching Delete Sequence with High Errors to “No” when running the GS Validate.

• Test system documentation and reports discrepancies through document review in preparation of live test events; develop documentation to give customers guidance on current systems.

• Coordinate installation of new IT systems, including software, hardware, and peripheral equipment.

Records Management Specialist I- OPDP Document Room 5/2015 – 12/2015 Zimmerman Associates Inc. Silver Spring, MD 40 Hours/Week Contractor for the United States Food and Drug Administration

• Processed electronic submissions associated with New Drug Application (NDA), Abbreviated New Drug Application (ANDA), and Biologics License Application (BLA) by entering drug information into Document Archiving Reporting and Regulatory Tracking System (DARRTS) accordingly.

• Maintained quality control over submissions processed.

• Filed archival submissions daily and made corrections as needed; analyzed and resolved various issues whenever errors occurred.

• Delivered priority submissions to building 51 for regulatory project managers as needed.

• Answered telephone and email inquiries in timely and professional fashion.

Computer Operator II – CDER Electronic 08/2011 – 04/2015 Heitech Services Inc., Silver Spring, MD 40 Hours/Week

Contractor for the United States Food and Drug Administration

• Processed paper and electronic documents in accordance with current SOPs, as FDA moves away from a total paper environment to an electronic paperless environment.

• Provided subject matter expertise in multiple data entry systems; selection and identification of relevant data, labeling, jackets, logging, assignments and all associated data entry with high level of accuracy.

• Performed data entry functions, as needed; redacted patient and/or manufacturer data.

• Assisted with identifying mitigations for vulnerabilities.

• Opened and date stamped mail, tracking mail in an electronic system, identifying issues and misroutes, reconciling mail, triaging document types, and performing priority processing for reports and submissions that meet specific criteria.

• Provided recommendations on information assurance planning, progress, and risks.

• Performed quality control checks according to project requirements.

• Produced documentation providing solutions that meet operational requirements i.e. enhancing existing tools, developing new methods for document identification.

• Conducted security monitoring to include intrusion detection, log consolidation, and protocol analysis.

Records Management Specialist II 09/2008 – 07/2011 Heitech Services Inc., Silver Spring, MD 40 Hours/Week Contractor for the United States Food and Drug Administration

• Processed about 10 to 20 Biologic License Application (BLA) submissions, received via gateway and courier mail; assigned classification codes and entered information in multiple databases maintaining filing systems and guaranteeing that only authorized personnel accesses appropriate documents.

• Performed general administrative duties including daily mail logging, affixing barcode labels on outgoing mail, distributing mails, photocopying and scanning documents, and filing archrivals when needed.

• Ensured quality assurance and control according to FDA regulations and procedures.

• Restructured filing system, cleared backlogs, and reorganized files.

• Trained and provided administrative guidance and advice to new co-workers.

• Provided clerical support to Regulatory Health Project Managers, Consumer Safety Officers, Regulatory Reviewers, and other FDA personnel by answering telephone queries and responding to requests via e-mail.

• Analyzed requests made via e-mail or over phone using Citrix and INVAS programs.

• Created general office tools using Adobe Lifecycle Designer 8.0, MS-Excel, and MS- Word following detailed guidelines; operated basic computer equipment or peripheral office equipment; ran scheduled daily work log reports.

General Clerk I 02/2006 – 08/2008 Alutiiq Security and Technology Inc. Silver Spring, MD 40 Hours / Week

Contractor for the United States Food and Drug Administration

• Processed outgoing 15 to 20 FDA-generated documents, letters, notifications, reviews, and memos daily.

• Assisted with file maintenance tasks such as checking order volume on daily basis; Reorganized volumes as needed.

• Opened, processed, photocopied, and distributed incoming mail; created, affixed, and scanned barcode labels daily.

• Wrote daily production reports and assisted Regulatory Project Managers, Scientists, and Medical Officers.

• Trained new staff to provide high level of customer service.

Education

Master of Arts in Ministry (MA)

Great Commission Bible College : Joplin, MO, July 2011 – March 2013

Bachelor of Business Administration (BBA)

International American University (IAU), Los Angeles, CA, 2008 - 2011

Diploma in Medical Transcription (DMT)

Blackstone Career Institute, Allentown, PA, 2008 - 2010

Bachelor of Business Administration (BBA)

Phoenix International University: WLG, New Zealand, 2001 - 2003

Certificate of Attendance in Computing Information System - American University Program

Inti University College: Kuala Lumpur, Malaysia, 1999 -2001

Mass Communication (Journalism)

Stamford University College, Kuala Lumpur, Malaysia, 2004 - 2005

Certificates & Licenses

• Certificate of English for Journalism, University of Pennsylvania

• Life Insurance License for Maryland and other non-resident licenses for other states

• Certificate of Teach English Now! Foundational Principles, Arizona State University

• Certificate of Teach English Now! Theories of Second Language Acquisition, Arizona State University

Awards

• Employee of the Month Award

• Recognition of 10 years of Outstanding Service on FDA Contract Award

• Thumps- Up Award

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