Cristina Naranjo Ortiz
Finance Committe Member @American Medical Writers Association Amwa
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WORK HISTORY
Finance Committe Member @American Medical Writers Association Amwa
GB
EDUCATION
University of Chicago
Certificate, Clinical Trials Management and Regulatory Compliance
Universidad Alfonso X El Sabio
Bachelor's degree, Physical Therapy/Therapist
Universidad Complutense de Madrid
Master's degree, Cultural Anthropology
University of Chicago
Certificate, Regulatory Writing
Universidad Alfonso X El Sabio
Doctor of Philosophy - PhD, Health Research
Universidad Alfonso X El Sabio
Master's degree, Research Methodology and Quantitative Methods
SKILLS
ABOUT CRISTINA NARANJO ORTIZ
Clinical Regulatory Writing Leader | Oncology & Multi-Therapy Expertise | IND/NDA Submissions | Publications & Process OptimizationI am a clinical regulatory writer with 8+ years of experience delivering high-quality documents that support global drug development and submissions. Over the last 3 years, I have authored 50+ protocols, 20+ CSRs, and 20+ IND/NDA applications, while leading cross-functional teams and managing the full document lifecycle. My expertise spans oncology (breast, GI, head & neck, hematological), as well as urology/urogynaecology, orthopedics, rheumatology, neurology, and immune disease.I also bring experience in strategic publication planning and execution, having authored 15+ peer-reviewed articles and contributed to 50+ posters, abstracts, and conference presentations. I bridge science, strategy, and communication to ensure data are presented with clarity and impact across both regulatory and scientific audiences.Selected achievements:* Streamlined regulatory timelines: Built a document template library that reduced protocol-to-FDA submission timelines from 9 months to 12 weeks.* Improved patient experience: Redesigned informed consent forms, simplifying language to an 8th-grade level and adding visuals, which improved IRB feedback and patient confidence.* Standardized processes: Created templates across protocols, ICFs, IBs, CSRs, and PLSs—enhancing quality, consistency, and accelerating submissions.
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