Noelle Osgood Warren

Dedicated research professional with considerable biopharmaceutical experience in preclinical pharmacology, toxicology, and drug development. Outstanding scientific and communication skills, with a proven ability to ensure on-time delivery of predetermined timelines for study/reporting milestones and regulatory submissions. Experience in nonclinical toxicology activities supporting all drug development stages from lead optimization (NME/Development Candidate declaration) to Phase 3. Preparation of nonclinical safety updates (DSUR) and regulatory submissions (CTA/IND, IMPD, and associated filings). Strong working knowledge of FDA, ICH, and other regulatory guidance. • Toxicology | general toxicology, genotoxicity, reproductive & development, juvenile, carcinogenicity assessment, safety pharmacology, drug development, planning, study design, protocol review, monitoring, report reviews • Scientific Writing | regulatory submissions, safety updates, integrate and summarize nonclinical data, CTA/IND, eCTD, medical writing • Communication | stakeholders at all levels of organization, internal/external teams, cross functional, matrixed; QA, Regulatory, CMC, Finance, Research, Development (R&D) • Project/Program | Strategic project planning, early and late phase • Organization | multi-tasking, team meetings, document/data/report reviews • Presentations | designs, data, updates, all levels of organization • MS Office | Excel, Word, Outlook, PowerPoint; Sharepoint; SmartSheet • CRO | study management & oversight, nonGLP, GLP • Statistics & Graphing | JMP, Prism• Data | review, reporting, presentation • Small & mid company experience • Small molecule • Therapeutic areas | CNS, Endocrine •