• Write CERs, regulatory plans, Post-Market Clinical Follow-up (PMCF) plans, Post-Market Surveillance Reports (PMSR), clinical SOPs and other medical device documents by skillfully appraising and analyzing clinical trials, literature, and experience data.• Create and present courses on a variety of clinical and regulatory topics including how to write new European Medical Device Regulation (MDR) compliant CERs, Investigational New Drug (IND) applications, technical writing, transitioning to medical writing, drug development, Good Clinical Practice (GCP) and Good Documentation Practice (GDP).• Update drug labels to meet the Pregnancy and Lactation Labeling Rule (PLLR).• Prepare and submit IND applications in the electronic Common Technical Document (eCTD) format using the Electronic Submissions Gateway (ESG).• Conduct literature searches to identify clinical gaps and draft literature review documents.• Read, analyze and implement regulations, standards and guidance documents (e.g. FDA, EU) relevant to client projects across multiple industries and disciplines.• Project management including planning, implementation, prioritization, and data analysis on behalf of clients to keep projects on time, high quality and within budgets.• Ensure quality by following and writing internal and external SOPs, Work Instructions and Forms/Templates for successful preparation of robust, high quality deliverables.

• Detail-oriented data analyzer, responsible for collecting, reviewing, and, verifying accuracy of data collected on three different projects, resulting in 2 pending publications and presentations at 3 national and 9 regional conferences. • Enthusiastic leader in multiple organizations, serving as treasurer, chair, and member of leadership council. Serving in these capacities, I managed and allocated a $6000 yearly budget, consulted with University leadership, facilitated meetings between KOLs and health science graduate students, and organized ~7 presentations/yr. When necessary, worked closely with other team members to problem solve and facilitate timely resolution of issues.• Experienced mentor to novice and advanced trainees. Mentored 9 graduate students during their first years and was nominated by these students for the UC BEST Program Peer Mentor Award. Additionally, I served as the lead lab mentor to 1 graduate student and 2 high school students, ensuring all required lab training was completed and documented. • Skillful trainer & curriculum developer, awarded a $6000 Diversity & Excellence Grant to design a biology training course. Trained 28 undergraduates in biomedical lab procedures, explained protocols and lab safety, including ensuring adherence to regulatory guidelines.

Taught underrepresented undergraduates basic molecular technology skills

• Awarded Colorado Clinical Translational Science Fellowship worth $29,300 to lead clinical trial initiation and implementation efforts.• Sought and established a new clinical trial on craniosynostosis by fostering a collaboration between the pediatric neurosurgery department at Children’s Hospital and the Williams’s lab; responsible for communicating clinical study status to team members. • Served as the head of trial management and the primary liaison between the sites while providing regular site status information to team members.• Sole preparer of clinical reports, including the IRB protocol necessary to fulfill the applicable local regulatory requirements.

Willpower Method and Pound Instructor

Pound Instructor

Tutored first and second year biology students.

Bio 101 Principles of Biology Bio 201 Cell and Molecular Biology

Summer 2010: Homoelog expression patterns of METACASPASE 9 in Domesticated Cotton Jonathan Wendel, PI; Mi-Jeong Yoo, Research AdvisorSummer 2009: Genetic Analysis of Seed Storage Proteins in Gossypium Jonathan Wendel, PI; Guanjing Hu, Research Advisor