Jessica McMorris
Memphis,TN
Summary
Regulatory affairs specialist with 10+ years of experience in academic and healthcare settings. Led integration of compliance systems and training programs, securing IRB approvals for 6,000+ studies. Recognized for analyzing complex regulatory environments and strengthening organizational compliance through dynamic solutions.
Overview
10
10
years of professional experience
Work History
Senior Regulatory Specialist
The University of Tennessee Health Science Center
Memphis
06.2019 - 08.2023
- Independently conducted regulatory and risk assessments for 6,000+ research protocols via the iMedRIS database system, implementing dynamic checklists to identify vulnerabilities for high FDA, HIPAA, and applicable regulations.
- Assessed contracts and orchestrated regulatory alignment of PMAs and 510(k)s and upheld research integrity by analyzing networks and design dossiers prior to issuing final approval
- Conducted investigator training, fostered FDA, HIPAA, GDPR, Health Canada compliance, and introduced innovative processes during the pandemic, maintaining a commitment to research integrity.
Guest Educator/Intervention and Exceptional Children's Teacher
Shelby County Schools (Tennessee)
Memphis
12.2017 - 05.2019
- Implemented tailored teaching methods and assistive tech, boosting state testing scores by using metrics
- Collaborated on effective interventions, crafting goal-centered individualized education plans based on IDEA regulations
- Achieved a 21% score increase through enhanced reading strategies and curriculum, exceeding our initial goal.
Research Compliance Coordinator and IRB Administrator
The University of Memphis
Memphis
04.2016 - 11.2017
- Led the integration of CayuseIRB (SaaS), overseeing project management and customizing the user interface development and training materials to enhance user adoption and research efficiency for regulatory submissions and CMC documentation
- Managed IRB meetings using Cayuse software for document assignments, ensuring compliance with diverse regulatory standards including FDA, APA, and applicable international guidelines
- Developed education sessions for researchers to ensure compliance with local policies, state laws, SOPs, and GDPR for technical documentation, labeling reviews, and artwork approvals.
Technical Writer/Cybersecurity Project Manager (Compliance Support)
University of Tennessee Health Science Center
Memphis
03.2013 - 04.2016
- Collaborated on diverse IT projects and spearheaded cybersecurity initiatives, enforcing regulations and integrating best practices utilizing HIPAA, ISO standards, NIST, FedRAMP, and SOC2 by conducting comprehensive analyses
- Led engaging awareness workshops, strengthened computer and information security protocols, and helped establish the inaugural Institutional Compliance Program.
- Enhanced user experience by simplifying complex technical concepts into easy-to-understand documentation, and increased product adoption by creating clear and concise user guides, manuals, and online help resources.
Education
Master of Science - Communication
Arkansas State University
Jonesboro, AR06.2011
Bachelor of Arts - Mass Communications
Rust College
Holly Springs, MS04.2009
Skills
- Regulatory Submissions
- International Regulations
- Stakeholder Engagement
- Project Management
- Training and Development
- Policy Development
- Regulatory Compliance
- Data Analysis
- Cross-functional Collaboration
- Problem-Solving
- Risk Assessment
- Regulatory Intelligence and Policies
- Audits
- ISO Standards
- Risk Management
- FDA Regulations
Certification
Certification(s) and Program(s) in Progress
- (ISC)² Candidate, Certified in Cybersecurity (CC), (ISC)², Inc., Course Completed in 10/2023, Exam Completion Date: 03/2024
- Certified Associate in Project Management (CAPM), Project Management Institute (PMI), Agile, Scrum, and Project Management for Beginners, Courses Completed in 07/2023, Exam Completion Date: 05/2024
Timeline
Senior Regulatory Specialist
The University of Tennessee Health Science Center
06.2019 - 08.2023
Guest Educator/Intervention and Exceptional Children's Teacher
Shelby County Schools (Tennessee)
12.2017 - 05.2019
Research Compliance Coordinator and IRB Administrator
The University of Memphis
04.2016 - 11.2017
Technical Writer/Cybersecurity Project Manager (Compliance Support)
University of Tennessee Health Science Center
03.2013 - 04.2016
Master of Science - Communication
Arkansas State University
Bachelor of Arts - Mass Communications
Rust College