Scientific Writer

Overview

Scientific Writer on the Scientific Writing team, translating nonclinical PK/PD and pharmacology data into regulatory narratives that support drug development and regulatory decisions. Serves as the primary scientific writing partner to Translational Pharmacokinetics & Pharmacodynamics and Nonclinical Pharmacology.

What you'll do

• Independently author nonclinical PK/PD study reports, eCTD summaries, and Investigator's Brochure content
• Lead development of integrated regulatory narratives that synthesize PK, PD, and mechanistic data
• Collaborate with scientists and cross-functional teams to interpret data and ensure consistent PK/PD messaging across programs
• Coordinate data inputs, reviews, timelines, and stakeholder communications to support high-quality, on-time deliverables
• Drive process improvements through authoring guidance, workflow optimization, and AI-enabled writing and quality-control solutions
• Serve as the scientific writing lead for assigned programs, providing strategic document planning and cross-functional coordination

What you'll need

• Bachelor's degree in a life sciences discipline
• Relevant combination of scientific and regulatory writing experience supporting nonclinical development programs
• Experience working with laboratory-generated pharmacology, PK, and/or PD data on a nonclinical drug development team
• Knowledge of drug development, eCTD guidelines, and ICH, FDA, and EMA/CHMP nonclinical requirements, including eCTD Modules 2.4, 2.6, and 4
• Experience using document authoring, review, and collaboration tools in a regulated environment

Nice to have

• Advanced degree (MS or PhD) in a life sciences discipline
• Submitting a cover letter is strongly encouraged

Details

• Location: remote, United States
• Work model: remote
• Many roles at Regeneron are required to be performed on-site; confirm on-site expectations with the recruiter and hiring manager
• Salary range: $109,900 - $179,300 annually