Brendan Mcdevitt Email & Phone Number

Chicago, Illinois, US

Dublin 2, IE

• Collaborates with clients in the pharmaceutical and biotech sector to publish and submit eCTD applications, i.e. INDs, NDAs, ANDAs, MAAs, and NDS’, to the FDA, EMA, and HC
• Leads an international Regulatory Operations publishing team that produced 675 submissions total for 2023
• Advises Regulatory Affairs and Operations professionals on how best to organize different submissions to the FDA
• Coordinated a major Advertising Promotional Launch for a product that was in the FDA’s Accelerated Approval Program
• Manages multiple clients’ complex Lifecycle Management submissions, especially Chemistry, Manufacturing, and Controls placement in eCTD Module 3
• Handles multiple types of submissions, including Annual Reports, Prior Approval Supplements, Changes Being Effected submissions, Administrative submissions, Labeling Supplements, Information Amendments, Protocol.

Dublin 2, IE

• Proficiency in using eCTD document management systems, i.e. ViewPoint, LiquentInsight Publisher, Veeva Vault, and Sharepoint.
• Published numerous PDF documents using Adobe Acrobat and it’s third-party extensions, i.e. ISI Toolbox and Evermap
• Experience using extensions to import and export.txt and excel files to quickly publish a document with bookmarks and hyperlinks
• Resolved issues stemming from validation errors or corrupted files through independent troubleshooting to keep the submission on track for delivery

King Of Prussia, PA, US

As a Legal Assistant with Portnoff Law Associates, Ltd., I conduct thorough Quality Assurance reviews of properties that have large real estate tax delinquencies. Primarily, I function to ensure that property owners are given enough notice that they owe overdue real estate taxes to their respective municipalities in accordance to Pennsylvania State Law and.

US

I directly work with an Assistant District Attorney that works in the Homicide Division. My role as an intern includes searching and organizing victims/eyewitness contact information, analyzing discrepancies in an assigned case, listening to prison tapes, and recording the minutes during hearings.

It was my job to research and write articles for Scenic Philadelphia's website, mostly pertaining to spreading public awareness about advertising firm's illegal activities. In addition to writing on the website, I helped manage the media art portion of the website. This means I found appropriate and relevant pictures to post on the website, sometimes I.

As an electrician's apprentice for the summer, I ran MC wire through various warehouses and businesses (often in steep locations as well as underground), dug out trenches to place PVC pipe, installed outlets for commercial use, removed and helped to install LED fixtures, and of course learned to maintain a clean, efficient workspace.