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Kate N. McSheffrey

Associate Publishing & Submission Support Specialist

Work experience

Oct 2013Oct 2015

Regulatory Affairs Associate Publishing & Submission Support Specialist

  • 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 2009Oct 2013

Regulatory Affairs Associate

  • 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 2008Dec 2008

Study File Analyst (Contract)

  • 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 2008Aug 2008

Clinical Research Assistant for Nephrology Department

  • 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 2006Dec 2007

Research Coordinator for Cardiology & Radiology

  • 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 2005May 2006

Intern, PEZ Research Lab, Psychology Department

  • 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



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