Executive Assistant Administrative
Resume:
DEBRA HUHN, Notary Public
********@*****.***
Executive Assistant
Executive Professional in Personal Care, Healthcare, Pharmaceutical, and Consumer Product industries. Progressive skills in Writing, Reporting, Supply Management, Scheduling, Microsoft Office, Organization, Time Management, Presentation, Equipment Maintenance, Travel Logistics, and Verbal Communication.
KEY AREAS OF EXPERTISE
Project Management Technical Databases Meeting & Event Coordination
Time Management Calendar Management Trained Administrative Team
Budget and Financial Tracking Supervision Chemistry Manufacturing Control
Key Performance Indicator (KPI) Executive Assistant
COMPUTER SKILLS /PROFESSIONAL EDUCATION
Enginuity Oracle Paradox
Visio Technical Data System Roxio
MS (Word, Excel, PowerPoint) Publisher Design-Pro
MS Outlook/Calendar Lotus Notes/Calendar Adobe Acrobat
SharePoint 2010 Agile CREDI
Concur SAP
CompuMaster – Morristown, NJ
Getting the Most from Microsoft Excel
How to Build Powerful PowerPoint Presentations
Rockhurst University Continuing Education Center – Cedar Knolls, NJ
Conference for Women
CDM Technical Training Institute – Wayne, NJ
Microsoft Excel 60 Hours
Computer Applications Learning Center, Inc. – Morristown, NJ
Intermediate Microsoft Excel
Microsoft Mail for Windows
Intermediate Paradox
CERTIFICATION
Notary Public (Sussex & Morris County)
FDA eCTD Overview and Submission
BioPharma Institute – GMPO: Documentation and Record Keeping (an Abridged Course)
PRA03: Preparing Submissions: Common Technical Document Form
Medesun Healthcare – Medical Coding & Billing
PROFFESSIONAL EXPERIENCE
Novartis, East Hanover, NJ 2016-2018
Quality Control Submission Coordinator/Administrative Assistant – Contract Position
oProvide operational support to the Oncology QC Submission Manager
oSupport vendor oversight and quality activities including: KPI monitoring, metrics collection and reporting as well as adherence to Oncology Submission Management and NVS guidelines.
oResponsible for qc findings form for Module 2
oOrganized meetings utilizing video-conference and teleconferencing
oWorked independently and determined priority handling
Colgate-Palmolive, Piscataway, NJ 2016-8/3/2016
Regulatory Affairs Specialist/Administrative Assistant – Contract Position
oSupport International Product Registrations for Most of the World
oProvide technical Regulatory and process support for Regulatory submission documents
oEnsure Regulatory documents are maintained according to internal procedures
oIn conjunction with new registrations, gather and prepare product registration documents
oWorked closely with business partners
oWorked independently and used discretion to determine priority handling
Edgewell Personal Care – formally Energizer Personal Care, Allendale, NJ 2015-12/11/2015
Sr. Regulatory Affairs Associate/ Administrative Assistant
Support International Product Registrations for LATAM and Asia Pacific Markets
oCompile documents to support submissions to Edgewell affiliates or government authorities
oGood Manufacturing Practices
oExecute FDA-Certificates to Foreign Government
oCertificate of Free Sale
oUS Legalization – Apostille or Consulate
oLATAM Dossier Assembly – Sun Care & Skin Care
oMaintain up-to-date product registrations including registration expirations, discontinuances or product changes
oUsed SAP to keep track on the inventory database.
oTrack, identify and measure trends in Regulatory transactions and initiatives
oWorked closely with business partners
Merck Sharp & Dohme Corp., Pharmaceutical, Kenilworth, NJ 2012-10/31/2014
Regulatory Scientist Assistant II – Contract Position
(Assistant to Regulatory Scientist)
oPivotal role for requesting most of world registration documents required to support Chemistry Manufacturing Control (CMC)
oSupport CMC variations such as drug product manufacturing site change
oRequests all ancillary documents:
oCPP – Certificate of Pharmaceutical Products – registrations of medical devices
oGMP – Good Manufacturing Practice
oPoA – Power of Attorney
oLoA – Letter of Authorization
oML – Manufacturing License
oLegalization of ancillary documents:
oNotarize – created and notarized authenticity letters
oApostille – documents sent to the country's embassy or consulant for legalization
oAssist with Health Authority questions.
oCreated and Maintain Track Requests
oLiaise with manufacturing sites, local regulatory liaisons to identify and obtain ancillary documents.
oAssist with Global Submission EU projects
Summary of Job Duties: Assist with regulatory documents for Module 3, sections 3.2S and 3.2P necessary for submission to the Health Authority.
Request Certificate of Pharmaceutical Products from the FDA and all over the world.
Compiling ANDAs, supplements, and annual reports.
Reckitt Benckiser, Global Consumer Goods, Parsippany, NJ 2009-2011
Global Regulatory Safety Environmental Assistant
oMaintained organizational charts and other department documents
oManaged calendars, scheduled meetings and arranged domestic/international travel
oPrepared, submitted, processed and tracked expense reports in Concur.
oPerformed critical administration to enable smooth team function. Scheduled and coordinated Metrics and KPI’s, calendar management, created master team calendars.
Acted as department representative and point of contact
Developed and implemented budget tracker to accurately track expenses
Coordinated meetings and events for up to 50 local and remote attendees, organized all logistics, selected an internal or external site, confirmed facility arrangements, managed food distribution, facilitated participant coordination, prepared materials and updated PowerPoint presentations
Coty Inc., Research & Development Center, Fragrance & Toiletries, Morris Plains, NJ
Executive Assistant for Senior VP’s, VPS and Directors 2004 - 2009
Managed complex and frequently changing of domestic / international travel arrangements
oOrganized lunches and refreshments for meetings
oCreated expense reports, budgets, and filing systems
oConduct research to prepare, gather, and proof briefing materials, agendas, and decks for all executive-level meetings
oAssist with team building initiatives and overall support for maintenance of organizational culture and employee morale
oWorked in partnership with other department coordinators and administrative assistance
oProcessing of invoices
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