Kate N. McSheffrey

Kate N. McSheffrey

Work History

Work History
Oct 2013 - Oct 2015

Regulatory Affairs Associate Publishing & Submission Support Specialist

TAKEDA PHARMACEUTICALS INTERNATIONAL CO.
  • Accurately and efficiently performed routine submission/correspondence archive-related activities; including all document review, data entry, and electronic document filing
  • Managed and supported the in-house Regulatory Electronic Tracking & Planning system, as well as maintained the Electronic Documents Management System (EDMS)
  • Managed electronic archiving of each submission and correspondence to and from Health Authorities (includes all global health authorities) in an efficient and precise manner
  • Worked closely (as well as independently) with the Regulatory Systems Business Support group on vital EDMS tasks; such as reclassifying necessary and essential documents, and appending the Product Dictionary to reflect all accurate and up-to-date project study information
  • Managed compilation and organization of crucial documents for numerous high-priority and time-sensitive audits
  • Consistently able to quickly locate and provide archived Regulatory documents (recent or historic) requested by Regulatory Affairs
  • Experienced and proficient knowledge of Regulatory documents, both submissions and correspondences from Health Authorities
  • Vast comprehension and familiarity with Regulatory Business Systems (tracking systems, planning systems, electronic archiving repositories, as well as various SharePoint site creation & maintenance)
  • Trained and supervised all new archiving/publishing employees and interns
Mar 2009 - Oct 2013

Regulatory Affairs Associate

MILLENNIUM PHARMACEUTICALS
  • Performed routine submission and archive-related activities, including document review, data entry, submission compilation for paper and electronic submissions, and document filing
  • Assisted with the evaluation, development, and implementation of systems and processes used to support regulatory activities; including planning and tracking regulatory activities, document requirements, document management, publishing, and archiving
  • Used electronic tracking and filing systems in order to follow good clinical practices and collect and capture all correct data
  • Communicated often with various agencies and health authorities, such as the FDA and EMA
  • Periodically submitted adverse event reports to the FDA
  • Worked closely with Regulatory Team members and supervisors, as well as independently, on various projects
  • Trained and supervised new employees and interns
Aug 2008 - Dec 2008

Study File Analyst (Contract)

INVENTIV CLINICAL SOLUTIONS ON SITE AT WYETH
  • Reviewed hard copy regulatory documents including 1572's, Clinical Correspondence, Confidentiality Agreements, Curriculum Vitae, Investigator Signed Approvals, IRB & IEC Documents, Microbiology Certificates and Serious & Non-Serious Adverse Events for 9 different studies with multiple sites per study
  • Entered documents into computerized data system
  • Performed file reviews for each site when requested by the Study Team
  • Assisted Study Team in close out of Study Sites
Jan 2008 - Aug 2008

Clinical Research Assistant for Nephrology Department

BETH ISRAEL DEACONESS MEDICAL CENTER
  • Worked on three different investigational drug studies concerning Polycystic Kidney Disease
  • Experience in editing/writing study grants and proposals
  • Wrote and worked on study sponsored protocols and informed consents
  • Organized and kept records for regulatory binders on all three studies
  • Extensive database work on multiple studies within the Nephrology Department
Dec 2006 - Dec 2007

Research Coordinator for Cardiology & Radiology

BETH ISRAEL DEACONESS MEDICAL CENTER
  • Worked on a cardiac surgical implant study regarding Angina
  • Acted as the liaison for study participants, study investigators, and all other members of the research team
  • Updated and maintained the patient study database
Feb 2005 - May 2006

Intern, PEZ Research Lab, Psychology Department

THE UNIVERSITY OF VERMONT
  • Senior research assistant for the Person Environment Zone Projects (PEZ)
  • Contacted participants in follow-up study
  • Entered data using Microsoft Excel
  • Assisted in organizing research and research results
  • Transcribed audio tapes
  • Helped to train other assistants

Education

Education
Sep 2002 - May 2006

Bachelor of Arts Degree in Psychology

The University of Vermont
  • Minor in English
  • Member of Alpha Chi Omega

Skills

Skills

Drug development


Regulatory submissions


Clinical trials & research


Highly skilled in filing and data archiving, with an apt knowledge of filing systems


Records management & records maintenance professional


Expert in database management and database management software


Project management expertise


Proficient in Microsoft Word, Excel and PowerPoint


Skilled in Adobe and Adobe Flash


Vast knowledge in SharePoint use, management and creation


Highly qualified in Proofreading