Senior Specialist, Nonclinical Medical Writing

Role: Experienced Medical Writer supporting nonclinical pharmacology documentation for biopharma development programs from FIH to global registration. Responsibilities: manage multiple projects, generate and review preclinical reports and regulatory modules (e.g., CTD, IND, NDA), synthesize nonclinical data, ensure regulatory and quality compliance, and contribute to documentation best practices. Collaborate with research and regulatory teams, oversee data integrity, and support document QC for business development activities. Qualifications: Bachelor's (7+ yrs), Master's (4+ yrs), or Ph.D. (1+ yr) in biology, pharmacology, or related field; strong scientific writing/editing skills; familiarity with regulatory filings for nonclinical modules; experience supporting early drug discovery and development; proficient with Microsoft Office and data visualization tools. Preferred: knowledge of oncology, neuroscience, immunology, or infectious diseases; experience with biologics, small molecules, or vaccine modalities; AI-enabled data tools; AMA certification. HighValue: focus on nonclinical pharmacology, regulatory submission support, and cross-functional partnership; development stages include FIH to registration; remote/hybrid setup; no travel required.