Technical Document Operations Specialists

BERNICE RENEE JACKSON

*** ******** **** ****

Audubon, PA 19403

Email: *******@*****.*** Cell: 610-***-****

SUMMARY

Efficient and effective document specialist with significant experience in the healthcare field.

Possess excellent organizational skills with hands-on technical knowledge. Detail-oriented with

strong work ethic. Self-starter with the ability to analyze business operations and recommend

strategies to improve performance. Engage in multi-tasking in high pressure work environment.

Maintain professionalism at all times and use discretion when handling confidential data. Excellent

interpersonal and communication skills.

AREAS OF EXPERTISE

• • •

Documentation Problem Solving Decision Making

• • •

Training Development Training and Development Innovative Approach

• • •

Compliance/Regulation Key Communicator Interpersonal Skills

PROFESSIONAL EXPERIENCE

Merck Pharmaceutical Ambler, PA 2013 – present

Technical Document Operations Specialist

• Perform system administration activities required to facilitate start-up/maintenance/ closeout

of study sites

• Perform manual data entry in: Trial Master File

• Review Trial Master File for duplications & misfiles of essential documents

• Ensure consistent receipt, review, filing and retrieval of hardcopy/electronic essential

regulatory documents

• Coordinate communications with study team regarding progress and completion of study

documentation

• Configure/ Create/ Monitor /Updated Regulatory Packages

• Coordination of study-specific Administrative Binders that are distributed to the study sites

• Maintain weekly document processing metrics/errors/returns/delays for department - excel

spreadsheet

Janssen Pharmaceutical Malvern, PA 2012 – 2013

Quality Assurance Document Specialists

• Reviewed/Approved Standard Operating Procedures (SOP), Work Instructions, Forms and

Master Batch Records (MBR) for reference content and formatting within Docspace

(EDMS)

• Reviewed Change Notice properties of SOP, MBR, WI & Form within Docspace

• Set-up effective date for SOP, MBR, WI & Forms

• Filed drug batch records

Wyeth/Pfizer Pharmaceuticals, Collegeville, PA 2006 - 2010

Clinical Trial Logistics, Study File Management Group

Document Specialist

• Performed quality review on critical clinical trial regulatory study documents.

• Utilized the E-Clinical system to capture and ultimately download documents into the

Electric Document Management System (EDMS).

• Managed Study Documentation to ensure the Company stays in compliance with

regulations that protect patients

Wyeth Pharmaceuticals, Radnor, PA 1999 - 2006

Senior Administrator II, Global Medical Affairs

• Provided office support to senior executives. Combine excellent organizational skills with

hands-on technical knowledge, memory for details and a strong work ethic.

• Entered Clinical Research Organization (CRO) contracts into the Grant Tracking system

(GTS).

• Designed a study tracking spreadsheet in Excel (monitor, pts. sites, cost per pt.).

• Designed Powerpoint slides for presentation.

• Coordinated promotional material and relocation services.

• Managed GroupWise calendar for AVP/Director.

• Scheduled and engaged in travel arrangement for multiple offsite meetings.

• Set-up European Quarterly Teleconference meetings.

• Set up WEB-EX meeting.

Wyeth Pharmaceuticals, Medical Affairs, Radnor, PA 1990 - 1999

Administrative Assistant

• Processed and expedited special formula/nutritional supplement orders.

• Replied to product inquiries from consumers and healthcare professionals.

• Set-up and maintained a data base for tracking orders.

• Typed, copied and mailed numerous product inquiry letters.

• Reviewed and filed expense reports

EDUCATION

HS Diploma

College courses

Regulatory Guideline Training

Online Compliance Training

Proficient in Microsoft Office

AWARDS

Wyeth-Ayerst Special Recognition Award

Contact this candidate