MEGAN McKINNEY New Hope, PA 18938 267.614.

4698
megn_1755@yahoo.com SUMMARY
Senior Regulatory Affairs Specialist with excellent organization and communication skills. Excellent troubleshooting skills; possesses the ability to work within tight corporate, department timelines and across multiple departments. Flexible and open to new work processes and experiences in the dynamic regulatory affairs sector and changing pharmaceutical industry.

TECHNICAL SKILLS
ISIToolbox Adobe Acrobat Standard & Professional Microsoft Word 2003, 2007, XP, 2010 ISIWriter 2.1 & Core Templates ISI eCTDXPress 3.1 ISIPublisher 3.0

PROFESSIONAL EXPERIENCE
MERCK, SHARP & DOHME, CORP. Upper Gwynedd, Pennsylvania 2011-2013

Contracted Registration Renewal Coordinator - Associate Level II, Regulatory Affairs (Two-year contract) Responsible for submitting and maintaining 100+ scheduled global registration renewals in a calendar year for Legacy Merck and Legacy Schering-Plough products; acting as the Regulatory Operations liaison in the coordination and smooth acquisition of all on-time deliverables. Initiated, coordinated, and finalized the global registration renewal process with Merck subsidiaries worldwide creating submissionready registration renewal packages to be submitted to their countries local Health Authorities Offered pre-submission strategies and fostered ongoing communication and follow up (written and oral) with global Merck subsidiaries, Worldwide Regulatory support teams and regulatory agencies throughout the lengthy registration renewal process to insure submission deadlines would be met Ordered and tracked needed documentation to support registration renewals (CPPs, GMP, Manufacturing Licenses, Letters of Authorization), facilitated their legalization and finalization, and maintained central filing system and repository for completed submissions Monitored ongoing renewal process within the respective therapeutic areas and provided guidance and updates to Regulatory, in-house teams and liaisons Communicated with key Merck departments and teams (International and domestic Regulatory, Clinical, CMC, Labeling, Legal, Manufacturing sites, etc.) to coordinate requests for continued support for current renewals, to insure critical submission deadlines would be met, as well as providing any follow up support for submissions under review Assisted countries with resolving issues outside renewal process that would affect ongoing renewal registrations: CMC issues relating to SOS chains, variations, additional manufacturing site documentation as well as scheduling urgently needed unplanned renewals
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ENZON PHARMACEUTICALS, INC. Bridgewater, New Jersey Sr. Regulatory Operations Specialist, Regulatory Affairs 2008 to 2010

2005 to 2010

Electronic Submission Publisher (Amendments/Supplements, Annual Reports, ACSR, EMEA, Orphan Drug, DDMAC). Assisted in the creation of new electronic submission publishing system. Managed dayto-day regulatory operations in busy Regulatory Affairs department. Organized and managed new document center & regulated document files. Played a critical role in creating and establishing the company-wide electronic ISI publishing environment. Built electronic and paper submissions for regulatory and clinical departments, utilizing ISI eCTDXpress and ISI Publisher to build and publish submissions. Submitted companys first electronic submission for new oncology product Processed eCTD and CTD documents for FDA submissions Researched product development projects for Regulatory, Legal & Corporate Upgraded electronic tracking to link document locations in Nordplan document center Sr. Document Control Specialist, Regulatory Affairs 2005 to 2007

CTD Submission Publisher for Regulatory Affairs and Clinical departments. Assisted in the creation, implementation and management of the new electronic document management system (Livelink DMS) for R&D / Regulatory Affairs department. Upgraded and managed Regulatory document center and all electronic repositories. Responsible for publishing and submitting 6 INDs and 3 pre-INDs in 2 years Identified preliminary processes, workflows for future SOP creation in preparation to transition company from a paper to electronic environment incorporating multiple IT upgrades Created electronic tracking system for regulated documents Led project to create electronic documents for DMS from legacy documents Submitted SPL (structured product label) to FDA Administrated Clinical Trials website; created website protocols Coordinated the move of the document center and regulatory files to new corporate site Coordinated Legal/R&D initiative to create company-wide document retention system Updated existing and created new tracking for regulated documents and new products BRISTOL-MYERS SQUIBB, Princeton, New Jersey 2000 to 2004

Contracted Document Specialist and Publisher 2004 Global Development / Regulatory Affairs Processed and published clinical documents and study reports Assisted medical authors, clinical writers and scientists making reports PRISM-compliant; Performed quality control reviews of clinical documents and reports at all publication stages CoreDossier Publishing, PRISM, Documentum & Windows XP

EDUCATION CHESTNUT HILL COLLEGE Philadelphia, Pennsylvania (2010-2011)

Pre-matriculating / 3.8 GPA

DELAWARE VALLEY COLLEGE - Doylestown, Pennsylvania

B.S., Ornamental Horticulture / Environmental Design
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