Clinical & Regulatory Data Consultant - Self-employed - Cary, NC
(2022-01)
- Execute data analysis and quantitative evidence synthesis of complex, multi-geography technology datasets for global life science clients.
- Audit structured technical outlines, validation protocols, and data-driven narratives to ensure absolute alignment with cross-functional quality standards.
- Clinical Trial Upskilling: Formally integrated human clinical trial architectures into consultation practices by completing active certifications in Advanced Good Clinical Practice (GCP), Data Management for Clinical Research (REDCap), and SAS Programming.
Senior Regulatory Science Writer / Technical Expert - Syngenta - Durham, NC
(2019-01 - 2022-12)
- Authored technical dossiers, scientific summaries, and structured regulatory narratives that successfully secured fast-track global approvals from health authorities, including the FDA and EFSA.
- Managed complex document submission pipelines using Veeva RIM, MS Project, Smartsheet, and real-time Gantt charts, tracking real-time data milestones and achieving 100% of dynamic submission timelines.
- Served as Study Director and Subject Matter Expert under GLP and ISO 12795 and ISO 9001 frameworks, validating data integrity, protocol adherence, and multi-disciplinary data packages.
- Project management tracking infrastructure for complex Regulatory Sciences and global submission projects to global regulatory agencies USDA, EPA, FDA, EFSA, ensuring meet dynamic timelines.
Regulatory Documentation Study Director - Corteva Agriscience - Johnston, IA
(2018-01 - 2019-12)
- Served as official Research Scientist and Study Director leading safety studies and analyzing multi-tiered datasets to generate high-quality regulatory data packages.
- Authored detailed scientific responses to resolve technical inquiries for global submissions, 50+ complex global agency inquiries annually.
- Partnered cross-functionally with biostatistics and data operations teams to deliver compliant toxicological summaries.
Regulatory Sciences Technical Leader - Dow AgroSciences - Indianapolis, IN
(2010-01 - 2018-12)
- Directed 4 global regulatory projects simultaneously, overseeing 250 data-intensive validation studies with an annual budget pool totaling $10 million.
- Authored and peer-reviewed over 100 bioinformatics reports and dossier modules, applying descriptive and inferential statistics (ANOVA, Regression, T-tests).
- Secured multiple major regulatory approvals across North America, Latin America, Europe, and Asia-Pacific regions by aligning technical narratives directly with global dynamic regulatory framework guidelines.
- Served as Study Director and Subject Matter Expert executing comprehensive molecular characterization, functional genomic studies, and bioinformatics allergenicity, toxicity safety assessments.
- Performed data quality verification and technical reporting on over 100 molecular and bioinformatics datasets.
- Applied descriptive and inferential statistical methods to ensure complete data validation and audit readiness of structural documentation packages.
