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KRISTINE J. MCGUIGAN
Hamburg, PA 19526

kmcguigan1107@gmail.com
SUMMARY:   
 
Looking for an on-site or remote position in Clinical Operations or Regulatory Affairs groups or something completely new!  I have 20 years experience as an Administrative/Executive Assistant working in Insurance industry, Religious/Non-Profit (at a synagogue), Car Dealership, etc. and overall, I have over 23 years experience in Pharmaceutics.  I own a fully-insured vehicle with clean driving record.
 
  I have been unemployed since January 2018 – I am looking to start working immediately.
                     
     Alternatively, my business – KMG Clinical is available for freelance/consulting work


EXPERIENCE:
 
  • CFR Title 21 (multiple parts – dietary supplements, food products, cosmetics, drugs, etc.)
  • Assisted small herbal products company become FDA compliant (Title 21, Part 111); Prepared 71 SOPs, researched & recommended inventory software; assisted with creating processes & procedures; all QA tasks
  • Crafting and updating of SOPs (administrative, personnel, equipment use, GMP, quality assurance, record keeping, business-specific, etc.) 
  • Quality Assurance tasks: preparing for audits, performing vendor qualification, crafted Quality Assurance Management Plan
  • HR tasks: collecting and reviewing CVs for open positions; crafting & collecting signed NDAs; completing I9 & obtaining supporting documentation; organized & facilitated new hire onboarding; filing of all personnel records and files
  • Clinical Trial Manager
    • 100% management of Phase 2 trial (with oversight) budgets, site selection, management of 20 sites for Oral Mucositis)
    • 50% management of Phase 2b (with oversight) (4 sites) for ABSSSI
    • included  purchase/storage/inventory/shipment of Clinical Supplies; oversaw shipment of IP shipments; interactions with IRBs
    • Assisted with creation of Protocol and Investigator Brochure
    • Created Informed Consents, manuals, and forms for clinical trials
    • CRO oversight as Clinical Trial Manager
    • Create and update study entries in clinicaltrials.gov
    • Planned and handled all arrangements for multiple Investigator Meetings including hotel Negotiation, menus, preparation of presentations, designing of give-aways
  • Vendor management (as admin and CTM) including selection, NDA, contract negotiation, review & approving invoicing
  • Over-saw roll out of ClinTrialApp for Oral Muscovites study; responsible for updating documents & other information in app
  • TMF Process Owner assisting w/resorting, unitization and oversight of the Trial Master File system
  • Supervised Clinical Trial Associates both TMF Specialists and Clinical Supplies Fulfillment
  • Functioned as Feasibility Coordinator to assist Business Development to gather data to prepare bids, for bid defense and to accelerate study start up by pre-identifying sites
  • Document level Quality Assurance for documents for inclusion in large FDA submissions.  Tasks included (but not limited to) Image QA, Bookmarking, Hyper linking and Identifying  issues (using proprietary software)
  • Participated with compilation of Common Technical Document (IND for brilacidin for ABSSSI and OM)
  • Created and submitted IND Annual Reports (hybrid paper & cd submissions)
  • Assisted with creation/preparation and performed submissions of Briefing Books for scheduled FDA Meetings
  • Assisted with preparation of electronic documents for FDA submissions including fact checking, proofreading, reformatting, etc.; also assist with  compiling  paper  submissions  to  FDA  including  preparing  multiple  copies  & shipping to FDA; also burned & tested CDs for submissions
  • Responsible creating and maintaining for all submission documents (1571, cover letters, etc.), preparation of submissions, shipping and filing of paper copies secure file room
  • Electronic filing for company records all FDA submissions; was responsible for controlling access to hard & electronic files to preserve integrity
  • Created contracts and confidentiality agreements; circulated for comments; finalized and collected signatures; filed paper & electronic
  • Executive Assistant to VP, Sr. VP, CFO, COO
  • Administrative Assistant (large & small departments, single & multiple managers)
  • Acted as back-up assistant to cover other admin-assistants
  • Managed calendar & contacts for multiple staff members
  • Travel arrangements (hotel/air/car rental or service)
  • Expense reports (single and multiple currency)
  • Created/edited and circulated meeting minutes
  • Created documents, letters, spreadsheets, etc. circulated for signature, shipped to recipients, filed paper & electronic copies as needed
  • Managed manufacturing budget of over $12,000,000
  • Organized meeting in Finland for 100 attendees; chose and contracted with hotel; made flight arrangements; prepared presentations; took meeting minutes, etc.
  • Managed preparation of all department meetings including room reservations, catering services, audio/visual aids, handouts, room supplies etc.
  • Prepared correspondence potential candidates; collected and prepared data in pre and post interview process; set up interview schedules and wrap-up meetings; updated company website with job postings
  • Represented company at college job fairs
  • Prepared and managed new employee orientation
  • Assisted with entering recruiting needs in HRIS internet-based resume system & archiving of information for off-site storage
  • Maintaining electronic Data Room
  • Supported the needs of multiple managers/department heads simultaneously
  • Data Entry/Double Data Entry directly into data management database
  • Designed & built personal website using Weebly and Wix
  • Purchased and inventories Office Supplies
  • Responsible for supplies for kitchens including contracting with coffee & soft drink vendors
  
SOFTWARE

Adobe Acrobat Pro X                                                 Microsoft OneNote 2007, 2010
Adobe Acrobat Reader                                              Go To Meeting
Microsoft Excel 2003, 2007, 2010                          Umark Watermarking Software
Microsoft PowerPoint 2003, 2007, 2010              Google, Internet Explorer, FireFox
Microsoft Outlook 2003, 2007, 2010                      Google Docs
Microsoft Word 2003, 2007, 2010                          Microsoft Windows 10
ScanSnap Manager/Scanner                                        Weebly Website Software
  
CURRENT EMPLOYER
KMG Clinical, Hamburg, PA                                                                                                                  Feb 2019 - present
Freelance/consulting                                                                                         

PREVIOUS EMPLOYERS

 
Innovation Pharmaceuticals (formerly Cellceutix Corporation), Beverly, MA                    2018-2018
Manager, Clinical Operations                                                                                         
Laid Off January 2018
 
BC Forward, Indianapolis, IN                                                                                                      
Contract assignment at Accenture, Wayne, PA   Regulatory Operations Associate             2013
Left for perm position at Cellceutix
 
PolyMedix, Inc., Radnor, PA                                                                                                                    2010-2013
Executive Assistant – supporting Clinical Operations/Regulatory Affairs and Research Teams
Company went bankrupt and closed
 
InVentive/MedFocus                                                                                           
Contract assignment at GSK Bio, KOP, PA supporting Procurement                                         2009-2010
Left for Perm position at PolyMedix
Short-term Contract assignment at Wyeth, Collegeville, PA supporting Clinical Team      2009 Temp Position only
 
Encorium Group, Inc., King of Prussia/Wayne, PA                                                                           2006-2008
Sr. Project Management Assistant supporting Chief Operations Officer & VP of Clinical Operations & Project Management Teams & Business Development Group
Laid off November 2008
 
 Vicuron Pharmaceuticals, King of Prussia, PA                                                                                  2001-2005
Executive Assistant to Executive Vice President of Scientific Affairs and Supported Director of Supply Chain Operations
Company purchased by Pfizer and was absorbed; laid off
 
Covance Periapproval Services, Radnor, PA                                                                                       1999-2001
Administrative Assistant to Recruiting Team of Human Resources Group
Resigned due to illness
 
IBAH/Omnicare/Thorem/Chilterm, Blue Bell, PA
Administrative Assistant to VP Data Management (began as Data Entry clerk)                   1996-1999
Left for Covance position
   
EDUCATION:
 
Katherine Gibbs Secretarial School, Philadelphia PA                                                                      1981-1982
Graduate, Secretarial & Word Processing Program
 
St. Pius X High School, Pottstown, PA – Graduate                                                                            1977-1981


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