Resume

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