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Work experience

2020-062024-03

Regulatory Writer / Regulatory Science Manager

Medpace, Cincinnati, US
  • As a medical writer, developed early-phase regulatory documents for oncology and a range of other indications, including for small molecule, antibody, and biological drug products. Projects included Briefing Packages for Type B FDA Meetings and early non-clinical (Module 2.4 and 2.6) documents. 
  • Contributed to the development of additional document types, such as IRT's Highlights of Clinical Pharmacology, Diversity Plans, Investigator's Brochures, and Clinical Protocols. 
  • Conducted quality control reviews on an array of document types, including those discussed above, along with Clinical Study Reports.
  • As a regulatory science manager, coordinated with internal and external Subject Matter Experts and other team members to develop pre-IND regulatory strategies.
  • Worked to execute regulatory strategies by leading writers in the development of Briefing Packages and coordinating Type B FDA meetings.
  • Conducted independent literature reviews in the development of slide decks and other niche internal documents.
2015-052020-05

Graduate Research Fellow

The Ohio State University College of Medicine and Nationwide Children's Hospital, Columbus, US
  • Designed and conducted scientific research in the laboratories of the Abigail Wexner Research Institute at Nationwide Children's Hospital.
  • Contributed to multiple peer-reviewed scientific publications.
  • Gave presentations of research data at seminars, journal clubs, lab and committee meetings, and professional scientific conferences.
  • Developed and delivered a series of eight lectures on cancer biology as part of the 2019 "Mechanisms of Human Health and Disease" program, cooperatively provided by Vanderbilt University, The Ohio State University, and Nationwide Children's Hospital.

PUBLICATIONS

González, J. F., Alberts, H., Lee, J., Doolittle, L., Gunn, J. S. (2018). Biofilm Formation Protects Salmonella from the Antibiotic Ciprofloxacin In Vitro and In Vivo in the Mouse Model of Chronic Carriage. Scientific Reports, 8(1), 222. 

 

Sprague, L., Lee, J. M., Hutzen, B. J., Wang, P. Y., Chen, C. Y., Conner, J., Cripe, T. P. (2018). High Mobility Group Box 1 Influences HSV1716 Spread and Acts as an Adjuvant to Chemotherapy. Viruses, 10(3), 132. 

 

Lee, J., Ghonime, M. G., Wang, R., Cassady, K. A. (2019). The Antiviral Apparatus: STING and Oncolytic Virus Restriction. Molecular Therapy Oncolytics. 13, 7–13. 

 

Hutzen, B., Ghonime, M., Lee, J., Mardis, E. R., Wang, R., Lee, D., Cairo, M.S., Roberts, R., Cripe, T., Cassady, K.A. (2019). Immunotherapeutic Challenges for Pediatric Cancers. Molecular Therapy Oncolytics. 15, 38-48. 

 

Lee, J., Ghonime, G.M., Cassady, K.A. (2019). STING Restricts oHSV Replication and Spread in Resistant MPNSTs but is Dispensable for Basal Interferon Stimulated Gene Upregulation. Molecular Therapy Oncolytics. 15, 91-100.