Regulatory submission production, QC, editing and preparation for publishing through ESG following FDA and ICH guidelines for the content and presentation of non-clinical and clinical regulatory documents in eCTD format• Format Word documents, apply templates and styles per client specifications, render to pdf• QC documents to source for accuracy for data and statements of fact• Create PDF documents with internal/external links and bookmarks• Use of SFTP to upload documents and make necessary file replacements• Use of Excel tracking sheet to monitor documents’ progress to readiness for esubmission; create short titles and name files appropriately to be esubmission compliant• Documents prepared: Clinical & Non-clinical Study Reports (in full granularity), Protocols, CRFs, Literature, Investigator Brochures, DSUR’s, Annual Reports, Meeting Packages, Module 2 Summary Documents, Module 3 documents (in full granularity)

Assisted with paper file organization for client making transition to electronic submission through ESG to FDA, prepared regulatory documents, QC, editing and preparation for electronic publishing following FDA and ICH guidelines for the content and presentation of non-clinical and clinical regulatory documents in eCTD format• Format Word documents per client specifications• QC documents to source for accuracy for data and statements of fact • Create PDF documents with internal/external links and bookmarks• Use of SFTP to upload documents and make necessary file replacements

Customer service; Internal/external office staff support; Accounts Receivable/Accounts Payable; Manage Salesforce database; Order processing, incoming shipments and Territory Manager scheduling

Direct supervision of 9 office staff members and 160+ in-home CAREGivers, recruitment of office personnel, companions and in-home aides, responsible for all documentation required to maintain state licensure for home care agency, develop and maintain excellent client relations ▪ Hiring, training, supervising and evaluating administrative and caregiving staff ▪ Development of internal and external office processes ▪ Data analysis for business growth ▪ Conflict resolution and customer service

Development, production and sales for a new advertising venue in the Crystal Coast, NC; created client base of for profit and non-profit advertisers; utilized Pipelinedeals.com to manage sales pipeline; organized distribution sites and routes ▪ Outside sales experience: cold calling, setting follow-up appointments, sales presentations, processing advertising space orders▪ Ad design ▪ Manage business financials using Quickbooks

Legal Assistant in a busy, civil practice specializing in bankruptcy and civil business matters; preparation of court documents and client correspondence; prepare and file Chapter 7 bankruptcy petitions; facilitate office implementation of Amicus Attorney data management system; process timeslips and generate client billing; front office reception of clients

▪ Developed partnerships with community resources ▪ Bolstered arts program with development of dance, drama and music staff ▪ Implemented Positive Behavior Support initiative ▪ Revised and strengthened Problem Solving Model/Response to Intervention student support referral and intervention process ▪ Coordinated transition plan for new $19,000,000 school construction project ▪ Managed federal, state and local budgets ▪ Grant writing ▪ Planned and facilitated major staff development trainings ▪ Hired, trained, supervised and evaluated staffs of 100+ employees

Redesigned Effective Teacher curriculum, taught 10 week sessions for teacher/substitute for CEU's at the BIG Center in the Continuing Education Department.