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Cheng Wen

@chengwen

Medical Writing Specialist at Edwards Lifesciences authoring clinical evaluation reports and regulatory submissions for cardiovascular devices.

United States

Message

At Edwards Lifesciences, I author clinical evaluation reports, benefit and risk analysis reports, literature reviews, and clinical study reports for regulatory submissions. I also contribute to efforts to improve the consistency of clinical evaluation processes and public-facing information.

At the University of Southern California, I supported research projects through quantitative analysis, data management, and manuscript preparation. My research experience includes clinical trials, patient-reported outcomes, evidence synthesis, and peer-reviewed publications.

Experience

Work history, roles, and key accomplishments

Current

Research Consultant

Current

University of Southern California

Aug 2022 - Present (4 years 2 months)

Provide technical support with existing research projects.

Current

Medical Writing Specialist

Current

Edwards Lifesciences

Jul 2022 - Present (4 years 3 months)

1. Authored internal and external reports:
-Clinical evaluation report
-Benefit and risk analysis report
-Literature review
-Annual progress report (for US and EU studies)
-Clinical study reports (CSR for regulatory submission)

2. Engaged in internal efforts to improve internal consistency of clinical evaluation process and public-facing information.

3. Collaborated with cross-functional t

Research Coordinator Supervisor

University of Southern California

Jun 2018 - Jul 2022 (4 years 1 month)

1. Evidence Synthesis:
- Quantative data analysis with intensive longitudinal data (collected using ecological momentary assessment and daily diary method) and panel data.
- Data Management
- Manuscript preparation (see ResearchGate for full reference https://www.researchgate.net/profile/Cheng_Kun_Wen)

2. Project Management
- Plan and execute primary data collection
- Obtain approval from ethic

Research Assistant

University of Southern California

Jun 2011 - Jun 2018 (7 years)

1. Data Analysis:
Quantative data analysis
- Regression-based models (linear, logistic, multi-level)
- Analysis of variance ((ANOVA), covariance (ANCOVA), and repeated measure ANOVA)
- Factor analysis, measurement reliability
- Measurement validity (Kappa statistics, Bland-Altman plot)
- Structural equation modeling
Qualitative data analysis
- Focus group
- One on on interview
Statistical Softwar

Systematic Review Abstractor

ICF

Apr 2017 - Nov 2017 (7 months)

Data extraction from published literature for the 2018 Physical Activity Guideline Advisory Committee. Key duties:
1) Screened included studies for inclusion and exclusion criteria;
2) Extracted study level characteristics of the included studies;
3) Assessed the quality and potential source of bias of the included studies.

Clinical Evidence Analyst

Doctor Evidence, LLC

Aug 2016 - Apr 2017 (8 months)

Data extraction from published studies. Main duties included
1) Screened included studies for inclusion and exclusion criteria;
2) Extracted study level characteristics of the included studies;
3) Assessed the quality and potential source of bias of the included studies;
4) Extracted effect sizes and relevant statistics to the proprietary software