Scientific Writer

Regeneron

. Independently author nonclinical PK/PD study reports, eCTD summaries, and Investigator's Brochure content .

Posted 10/6/2026full-timeRemote • United StatesMid-LevelSenior💰 $109,900 - $179,300 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in scientific and regulatory writing, particularly in nonclinical PK/PD study reports and regulatory narratives. Proficient in collaborating with cross-functional teams to translate complex data into clear documentation that supports drug development and regulatory compliance.

Highest-signal resume keywords

Scientific WritingRegulatory WritingPK/PD Data InterpretationECTD Guidelines KnowledgeCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Nonclinical Study ReportsRegulatory NarrativesData SynthesisDocument AuthoringPharmacology Data Analysis

Soft Skills

CommunicationCollaborationLeadership

Tools & Technologies

Document Review ToolsCollaboration ToolsAI-Enabled Writing Solutions

Industry Keywords

Drug DevelopmentECTD ModulesICH GuidelinesFDA RegulationsEMA/CHMP Requirements

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

Bachelor's degree in a life sciences discipline
Advanced degree (MS or PhD) preferred
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
Background checks may be conducted as part of the recruitment process
Must provide information verifying identity, right to work, and educational qualifications if required

Benefits

Comp & perks

Annual bonuses or other incentive plans
Equity awards
Pension or retirement benefits
401(k) company match
Health and wellness programs
Fitness centers
Medical, dental, vision, life, and disability insurance benefits
Paid time off
Family support benefits
Reasonable accommodation during the recruitment process where required