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Satish Guttikonda

@satishguttikonda

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I review clinical and regulatory data packages, strengthen eTMF integrity, and support submission-ready documentation.

United States

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What I'm looking for

I'm looking for Clinical Data Specialist or Clinical Trial Document Reviewer work focused on critical data package review, eTMF integrity and auditing, regulatory compliance, data validation, and submission-ready documentation.

I review clinical and regulatory data packages for global life science clients, applying rigorous quality control, data validation, and document review to SOPs, clinical study reports, protocols, and QMS documentation.

At Syngenta, I authored, edited, and formatted complex dossiers, technical outlines, and agency response summaries for FDA, USDA, EPA, and EFSA submissions. I managed Veeva Vault RIM workflows and peer reviews to maintain version tracking, style compliance, and data integrity.

At Corteva Agriscience, I led safety studies and analyzed multi-tiered datasets to produce regulatory data packages. I partnered with biostatisticians and operational leads to resolve data discrepancies and responded to more than 50 complex global agency inquiries annually.

Earlier, I managed editorial and QC review cycles for four global regulatory projects spanning 250 technical validation studies. I bring a PhD, TMF Specialist certification, clinical data management training, and a record of 12 peer-reviewed publications and multiple regulatory approvals.

Experience

Work history, roles, and key accomplishments

Current

Clinical & Regulatory Data Consultant

Current

Self-employed

Jan 2022 - Present (4 years 8 months)

Performs quality control and data validation of scientific SOPs, clinical study reports, protocols, and clinical data packages for global life science clients. Reviews QMS documentation, identifies data deviations, and assists in drafting CAPAs.

Quality Control Data Validation SOP Review Clinical Study Report (CSR)Protocols QMS CAPA Templates Trackings

Technical Regulatory Editor / Validation Expert

Syngenta

Jan 2019 - Dec 2022 (3 years 11 months)

Authored, edited, and formatted complex dossiers, technical outlines, and agency response summaries to ensure 100% submission compliance for FDA, USDA, EPA, and EFSA. Managed Veeva Vault RIM document workflows and conducted rigorous peer reviews for style compliance and data integrity.

Veeva Vault RIM Suite Document Management Peer Review Regulatory Submissions FDA USDA EPA EFSA Style Guide Compliance Version Control

Regulatory Documentation Study Director

Corteva Agriscience

Jan 2018 - Dec 2019 (1 year 11 months)

Served as Research Scientist and Study Director leading safety studies and analyzing multi-tiered datasets to generate regulatory data packages. Authored scientific responses to resolve technical inquiries for global submissions, managing documents in Veeva Vault RIM.

Veeva Vault RIM Suite Regulatory Documentation Data Analysis Biostatistics Research Direction Global MAA Submissions Technical Writer

Regulatory Technical Document Reviewer

Dow Sciences

Jan 2010 - Dec 2018 (8 years 11 months)

Conducted and managed editorial and QC review cycles for 4 global regulatory projects encompassing 250 data-intensive technical validation studies. Proofread, formatted, and audited 100+ technical dossiers and study report modules, ensuring precise application of descriptive and inferential statistics.