Nancy Maurer-Bragg

Reviews original copy for edits for variety of consumers, professional healthcare and internal AbbVie audiences and functions as primary Quality Assurance check. Assesses copy determining and performing level of edits necessary, looking for sequence of thought, logic, flow and consistency. Compares copy for interactive projects against any existing detail aids or other print pieces to ensure technical content, style and accuracy of date incorporated are maintained while preserving readability. DOES NOT REWRITE COPY. Proofreads copy for : Accuracy, Grammar, Spelling, Consistency, Referencing and annotating in preparation for medical/regulatory review, Conformity to established client style. Reviews medical copy for precision, clarity and technical/structural accuracy. Annotates/fact-checks reference citations for submission to medical/legal/regulatory reviews. Maintains master list of references for brands. Supports Label changes and Products Launches.

Prepare design records for archiving Prepare design records for archiving in RIMs (Corporate Records). Reconcile migration issues and problems and problems against Epas CR history. Prepared excel spreadsheets for RIMs tool by moving data and using concatenation formulas to create new date columns.

Received and retrieved essential documents for Clinical Research Specialists (CRS), Clinical Study Assistants (CSA) and Clinical Research Organizations (CRO). Managed Trial Master File and Product File, ensuring documents maintained in file were appropriate and content of those documents was accurate, complete and consistent with AbbVie SOP’s and regulatory requirements. Managed archiving of Trial Master File, ensuring files were archived without one year of Clinical Study Report and files were maintained per applicable AbbVie's SOP’s.

Reconciled Trial Master File versus vendor and/or virtual components of TMF, essential document tracker and input from Clinical Teams, CRS’s, and or CSA’s prior to archival. Manage request for Investigator Site Files (for archival at AbbVie. Provided requested documentation during and audit and /or inspection and identified potential compliance gaps.

Maintained and controlled all ADD Validation/MQA Records.  Created and controlled ValTrack 2000 Document Control Database.  Handled all customer requests, which included pulling hard copies, scanned copies and validation packages, running reports and retrieving records from Corporate Records.  Supported International and in house audits.  Approved MES (Manufacturing Execution System).  Trained and managed all summer interns and new employees.   Issued validation numbers, managed and controlled them in ValTrack 2000.  Initiated scanning project which converted all manual documents to electronic files for cost savings and improved searching

Revised and proofread manufacturing documentation and Bill of Materials per approved change requests.  Worked with Document Editors to support document development for new product teams per aggressive time lines; supporting documentation project teams and CR tracking; and filling approved documents per Device Masterfile requirements.

Received all incoming customer and sales force calls, evaluating and obtaining all relevant information to handle product and service inquires.  Maintained customer service database.