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Evan Winiger

@evanwiniger

I lead FDA-regulated scientific and regulatory writing from complex evidence to submission.

At Altria Client Services, I author regulatory and scientific documents and have led five Premarket Tobacco Product Applications through every phase of scientific and regulatory review.

I turn complex study data into clear, evidence-based submissions that meet FDA-defined requirements. I partner with regulatory affairs, government affairs, and subject-matter experts to resolve ambiguous input and keep documents accurate under demanding timelines.

I founded and lead the Policy Impact Evaluation System, a cross-functional writing team, while mentoring colleagues and overseeing external writing vendors. My work was recognized in 2024 with my department's highest performance rating.

Earlier, I led research projects through peer-reviewed publication, developed manuscripts with external collaborators, and managed protocol manuals and IRB submissions for federally funded longitudinal studies. I hold a Ph.D. in Behavioral Genetics and have authored or co-authored 23 peer-reviewed manuscripts, including 11 as first author.

Experience

Work history, roles, and key accomplishments

Current

Principal Research Scientist I

Current

Altria Client Services

Jun 2022 - Present (4 years 3 months)

Serves as subject-matter expert authoring regulatory and scientific documents, including five Premarket Tobacco Product Applications (PMTAs), through all phases of internal scientific and regulatory review. Collaborates with cross-functional teams and manages document review processes.

Regulatory Writing Scientific Writing PMTA Cross Functional Collaboration Document Review Vendor Oversight SOP Development FDA Compliance Project Management Mentorship

Postdoctoral Research Fellow

University of Colorado Anschutz Medical Campus

Jun 2021 - Jun 2022 (1 year)

Independently led manuscript development for multiple concurrent research projects, coordinating with external collaborators and institutional stakeholders.

Manuscript Development Research Coordination Collaboration

Research Scientist

University of Colorado Boulder

Aug 2017 - May 2021 (3 years 9 months)

Led five research projects from design through peer-reviewed publication, applying advanced statistical methods to datasets ranging from small clinical samples to national datasets of 600,000+ participants.

Research Statistical Analysis Data Analysis Publications

Laboratory Coordinator & Lead Coordinator

University of California, San Diego

Aug 2014 - Aug 2017 (3 years)

Drafted protocol manuals and led IRB applications, amendments, and continuing reviews for two federally funded longitudinal studies, applying foundational Good Clinical Practice and human subjects research standards.

IRB Protocol Development Good Clinical Practice Human Subjects Research Coordination