Jason Aligo
Director, Global Nonclinical Writing & Submissions, Johnson & Johnson Innovative Medicine @Johnson & Johnson Innovative Medicine
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WORK HISTORY
Director, Global Nonclinical Writing & Submissions, Johnson & Johnson Innovative Medicine @Johnson & Johnson Innovative Medicine
Lead and mentor a global nonclinical writing team (internal + contractors).* Deliver nonclinical submission content (IB, IND/CTA/NDA modules, briefing books, HA responses).* Review and QC documents for standards, compliance, and clear risk messaging.* Evolve nonclinical submissions strategy to align with the global regulatory landscape.
EDUCATION
Penn State University
MS, Genetics, Virology, and Molecular Biology
University of Hartford
B.S., Biology
Penn State University
Ph.D., Genetics, Virology, Molecular Biology
ABOUT JASON ALIGO
People leader and senior research scientist with expertise in global nonclinical regulatory writing and submissions in pharmaceutical R&D. Director, Global Nonclinical Writing, leading a geographically distributed team delivering nonclinical documents for INDs, IBs, briefing books, and global regulatory interactions.15+ years of scientific experience spanning molecular pathology, immunotoxicology, virology, molecular/cell biology, and biochemistry. Continues to deepen expertise in global nonclinical writing and submission strategy in close partnership with cross functional teams.Focused, pragmatic leader in fast paced matrix environments, valued for organization, problem solving, and adaptability. Committed to mentoring talent and bringing clarity at the intersection of science, process, and regulatory strategy.Areas of expertise:· Global Nonclinical Writing & Submissions · Regulatory Documents (INDs, IBs, Briefing Books, Study Reports) · Molecular Pathology & Immunotoxicology · Virology, Molecular & Cell Biology, Biochemistry · Scientific Strategy & Data Integration · Assay Development (Preclinical/GLP‑like/non-GLP Environments) · Cross‑Functional Leadership & Mentoring · Process Optimization· Immune Surveillance & Translational Science · Electron & Fluorescence Microscopy · Immunohistochemistry / In Situ Hybridization · In Vitro & In Vivo Models
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