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Vera Hedtke

@verahedtke

Biomedical AI evaluator at ACAD Write assessing scientific claims, evidence, and citations.

At ACAD Write, I write and review scientific publications and assess AI-generated scientific work for factual validity, reasoning, and support in published literature. I verify sources and check scientific claims against the evidence.

At Opterion Health, I develop and revise clinical study protocols, Investigator’s Brochures, clinical communications, and lay summaries. I also prepare preclinical publications and manage scientific literature and references.

My work with Fresenius Kabi GmbH, Pharmaceutical Division included preparing and reviewing regulatory and clinical documents, including clinical study reports and eCTD submission materials. I also independently analyze biomedical research data using IBM SPSS Statistics and interpret findings for manuscripts and presentations.

Experience

Work history, roles, and key accomplishments

Current

Scientific & Medical Writing Consultant

Current

Opterion Health

Nov 2024 - Present (1 year 11 months)

Develop and revise clinical study protocols, Investigator's Brochures, clinical communications, and lay summaries. Assess scientific accuracy, consistency, and completeness of clinical and preclinical content.

Clinical Study Protocols Investigator Medical Writing Scientific Writing Publications Management Regulatory Documentation

Current

Medical Writing & Scientific Communications Consultant

Current

KRIEEN

Oct 2024 - Present (2 years)

Develop medical and pharmaceutical communications materials for pharmaceutical clients. Substantiate medical and promotional claims against scientific literature and clinical evidence.

Medical Writing Scientific Communications Pharmaceutical Communication Claim Substantiation literature review

Current

Medical Writer – Patient Communications

Current

Snow Companies

Sep 2024 - Present (2 years 1 month)

Develop discussion guides for patient-focused webinars and capture patient narratives. Review patient communications against compliance requirements and project-specific guidance.

Medical Writing Patient Communication Discussion Guides Compliance Review Narrative Development

Current

Scientific Writer & Scientific Quality Manager

Current

ACAD Write

Jan 2019 - Present (7 years 9 months)

Write scientific and medical publications and presentations; conduct substantive scientific editing and quality review of research manuscripts. Independently analyze raw medical and biomedical research data using IBM SPSS Statistics.

Scientific Writing Medical Writing Editing Quality Review SPSS Statistical Analysis AI Content Evaluation Fact Checking Citation Verification

Medical Consultant – COVID-19 Vaccine Communications

BioNTech via WE Communications

Dec 2020 - Feb 2021 (2 months)

Developed evidence-based, consumer-facing FAQs explaining the novel COVID-19 vaccine during its development and introduction. Translated complex vaccine-related scientific information into accessible patient and public communications.

Medical Writing Science Communication COVID 19 Vaccinations FAQ Development Public Communications

Medical Writing Manager

Fresenius Kabi GmbH

Oct 2016 - Nov 2019 (3 years 1 month)

Prepared and reviewed regulatory and clinical documents, including clinical study reports, IMPD inputs, clinical dossiers, company core data sheets, and eCTD submission materials. Reviewed internal and external publications and contributed to product monographs.

Regulatory Writing Clinical Study Report (CSR)IMPD eCTD Clinical Dossiers Medical Writing Publication Review