Experience

Pyros Pharmaceuticals

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Lead Regulatory Affairs Publishing Specialist

  • May 2022 - Present

  -Manage, create, and submit FDA eCTD submissions according to ICH and regional guidelines -Format documents according to ICH and regional standards using DXC Toolbox (formerly known as ISI Toolbox) -Create and execute validation documentation in coordination with QA and IT departments for the successful implementation and updates of docuBridge and eValidator -Generate validated SPLs (including Human Prescription Drug Labels and Labeler Code Requests) using the FDA’s tool “SPL Xforms” -Create and maintain SOPs related to the regulatory publishing process to maintain QA compliance -Assist Regulatory Affairs in the creation of administrative documentation for regulatory submissions -Perform regulatory research and share information with applicable departments Show less



EXTEDO

• Germany
• Software Development
• 1 - 100 Employee

• US Team Lead, Global Publishing Services

  • Apr 2019 - May 2022

  -Prepare and publish eCTD and non-eCTD submissions in the proper format and submit to the appropriate regulatory authority, including the FDA, EMA, and Health Canada -Perform quality checks for document and submission integrity and compliance to regulatory standards including ICH guidelines and regional authority standards -Maintain relationships with clients by communicating quickly and effectively and by providing excellent customer support -Coordinate publishing work among the team to enhance the overall knowledge of the different types of submissions in various regions -Troubleshoot document and submission issues and provide guidance to clients on best practices and regulatory requirements -Review and revise SOPs relating to the processes and procedures of the Global Publishing Department to maintain QA compliance -Train clients and EXTEDO employees on eCTDmanager and Regulatory Submission Publishing using materials that I created Show less



College Possible

• United States
• Non-profit Organization Management
• 300 - 400 Employee

• High School Junior Coach

  • Aug 2017 - Jun 2018

  Served low-income high school juniors in Philadelphia to help them get accepted to and succeed in college Created and maintained strong relationships with the school staff including the guidance counselors and office administration Facilitated after school sessions focusing on SAT preparation to increase the students’ likelihoods of being accepted to four-year institutions Reviewed student essays to increase their chances of college acceptance Analyzed student scores on practice tests to determine the course of session content Recruited sophomores enthusiastically to join the class of 2020 cohort to continue College Possible’s mission Updated students’ personal and academic records through Naviance and CoPilot to enhance the data on the student for future coaches Show less



West Chester University of Pennsylvania

• United States
• Higher Education
• 700 & Above Employee

• Help Desk Intern

  • Apr 2014 - Aug 2017

  Answered phone calls and assisted clients in the office in a friendly, helpful manner to support faculty, staff, and students with 1st-level and 2nd-level issues with university-provided machines and university-issued software Installed and upgraded university-provided software including Microsoft Office Suite, SPSS, SAP, and RamCloud (Citrix Receiver)Remoted into university-provided machines using Bomgar to effectively troubleshoot software-related issuesCreated detailed records of every troubleshoot or installation incident to expand the knowledge base on software or hardware related issuesCreated instructional material for students such as printing procedures for the computer labs and the proper installation of RamCloud Opened or closed six computer labs and the help desk office to ensure the safety of university machines Show less

• Peer Tutor

  • Sep 2015 - Apr 2016

  Tutored fellow students in General Biology and Beginner’s Spanish to pass along the knowledge I had gained from those coursesIncorporated various tutoring methods to accommodate different learning stylesEvaluated the progresses of the students’ abilities to learn independently to help them become successful learnersProvided detailed records of the sessions and the students’ attendance to supervisors in a timely manner

• Co-Leader for Affordable Housing Alternative Break Trip

  • Sep 2015 - Mar 2016

  West Chester University's Office of Service Learning and Volunteer Programs offers alternative break trips for students, faculty and staff. In this position, I worked along side another co-leader and successfully marketed, planned, and executed an alternative spring break trip to West Virginia serving a local resident through Habitat for Humanity.



West Chester University of Pennsylvania

• United States
• Higher Education
• 700 & Above Employee

• Peer Assistant

  • Jun 2013 - Aug 2013

  West Chester University offers a summer program to high school graduates who applied to the university but did not quite fit the academic requirements. This program is a chance for students to develop the academic skills necessary for success at a post-secondary institution. My role was that of a Peer Assistant which is equivalent to a Resident Advisor. I supervised a group of 12 students to ensure their successes in the program by meeting with them regularly and offering my advice and support. I also worked closely with my peers to plan fun and interactive programs for the students to improve the students' experiences in the program. Show less