Jeanette C. Amann

**** ***** ******, ***. *

Bristol, WI 53104

Cell - 262-***-****

E-mail: accznk@r.postjobfree.com

Objective

To obtain a position with a highly reputable, growing company that enables me to utilize my strong organizational,

communication and time management skills to excel according to the company‘s mission and values and make a

positive contribution to the company.

Specialized Skills

Typing 75 WPM, dictaphone, shorthand, proficient in Microsoft Suite, other numerous computer programs,

informational databases and medical and scientific terminology. Excellent ability to interact with people in a

professional manner, work proactively and efficiently with confidential and sensitive data, work in an environment of

constantly changing priorities and anticipate the needs of management.

Experience

3/11 – 6/12 Astellas (Randstad Pharma Contractor) Trial Master File Associate

Audit Trial Master Files for archiving and in preparation for Corporate and FDA audits using a documentum database

(CDEx) to classify documents for easy retrieval.

Create and update Work Process Documents and Standard Operating Procedures for Operations Manual..

Index, verify and scan documents for archiving.

Assist in other special projects as assigned.

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5/10 – 3/11 Takeda Pharmaceuticals (Delta-Pharma Contractor)

Records Coordinator

Prepare clinical documents for archiving according to file retention schedule and Standard Operating Procedures (SOPs)

including data entry of Trial Master Files, Pharmacovigilence Line Listings and Expedited Reports (Severe Adverse

Events) into a Records Management System (RMS) using appropriate naming conventions.

Scan documents from a desktop scanner to ensure that documents are submission ready as well as attaching renditions of

scanned documents into records in RMS.

Created a procedure for Records Management staff to understand and be proficient in preparation of files/boxes.

Coordinate and track daily and monthly box shipments to outside vendor for scanning in preparation for shipment to Iron

Mountain..

Assign and track backlog file processing.

Assist in other special projects as assigned.

8/09 - 1/10 NeoPharm, Inc. - Lake Bluff, IL

Document Specialist/Accounting Assistant

Provide part-time document specialist/accounts payable support to Regulatory Affairs, Clinical and Accounting, back-up

to Executive Assistant.

Format clinical protocols and investigational brochures, maintain Clinical Trial Master files, extract adverse event data

from CRFs (Case Report Forms) for tracking into Excel spreadsheet, review completed CRFs to ensure ICH Guideline

compliance.

Prepare incoming invoices for payment in an accounting database by reconciling invoices, entering data and printing

checks.

Provide support for other miscellaneous projects as needed.

8/95 - 11/08 Abbott Laboratories – Abbott Park, IL

Document Specialist – Global Analytical Research & Development & Neuroscience Development

Clinical Research Administrator/Administrative Assistant – Center of Clinical Assessment

Administrative Assistant – Process Development, Corporate Licensing and Direct Marketing

Responsible for providing reports and developing spreadsheets containing research data.

Format and proofread analytical methods and certificates of analysis, ensure receipt and filing of essential documents

for Phase I - IV clinical trial study files per (CFR) Code of Federal Regulations Guidelines and (SOP) Standard Operating

Procedures, distribute clinical study protocols, file, track and follow-through on data management queries, and enter data

in an electronic submission database.

Maintain current Trial Master Files ensuring all documents were updated during clinical trial.

Jeanette C. Amann

March, 2014

Page Two

Work closely with Safety Review Nurse in processing and tracking DCFs (Data Clarification Forms) and

submitting to CRO for completion.

Sole manager of data entry and tracking analytical methods, business leads and clinical trials via company wide database.

Utilizing eRoom for storing and retrieval of analytical and departmental documents.

Archive closed clinical trials, reviewing each site file, indexing and submitting to Corporate Records.

Scan scientific documents for change request filing with Documentation Center.

Retrieve archived documents from Quality Document Management System (QDMS), a Documentum program.

Scan, file and name clinical trial documents for filing with FDA through e-Docs.

Organize entire file room to consolidate duplicate files, i.e. analytical methods, certificates of analysis.

Initiate, track and follow-through on contracts, i.e. Confidentiality Agreements, Letters of Indemnification, etc.

Retrieve and review paper and electronic files for audit preparation and participate in Corporate Quality Assurance

audits.

Provide administrative support to department employees, manage calendars and travel arrangements for 4+ managers,

schedule internal and external meetings as well as teleconferences, participate in team meetings, coordinate entire process

for applicants and new hires in a department with a constant turnover of employees due to promotion to field sales,

manage inventory of training related materials, order office supplies and maintain office supply budget as well as a variety

of other projects as needed.

High volume of telephone contact with internal and external customers in a professional manner.

Prepare and follow-up on administrative check requests, purchase orders, expense reports, etc.

2/06 - 10/07 Lake Shore Orthopedics - Gurnee, IL - Medical Transcriptionist

Medical transcription for 8 orthopedic specialists on a prn basis.

9/94 – 8/95 Michael H. Groused, D.D.S. - Vernon Hills, IL - Secretary Oral/Maxillofacial Surgery

Medical transcription, coordinate patient appointments and surgeries, maintain patient database, medical collections, third

party reimbursement, CPT and ICD9 coding, and perform basic surgical assistant procedures.

2/86 – 8/94 Saint Therese Medical Center - Waukegan, IL - Medical Admin. Secretary – Medical Affairs

Coordinate medical staff office for assistance to 250+ medical staff, credential physicians applying for staff

membership, maintain current knowledge of Joint Commission Accreditation on Healthcare Organizations (JCAHO)

guidelines and participate in surveys, maintain credential files, schedule medical staff committee meetings, prepare

agendas, document and transcribe minutes and prepare follow-up, draft letters, reorganization of medical staff office,

facilitate “VALUES” classes for employee education and implement physician database (MIDS) and credentialing

system.

Education

High School Diploma – Waukegan Township High School and various courses in Lotus Notes, Microsoft programs

and informational databases.

Memberships & Awards

Global Pharmaceutical R&D Research Inclusion Council /Abbott Laboratories 2004/2005

Recipient of SPOT Awards, March, 2006 and November, 2006 and Certification of Appreciation Award for Team

Contribution on an Investigational New Drug Application (IND), November, 2007

References available upon request

Contact this candidate