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Regeneron is a biotechnology company that discovers, develops, and commercializes medicines for serious and underserved conditions. Its research spans allergy, cardiovascular and metabolic disease, neuroscience, oncology, hematology, ophthalmology, and rare diseases. By combining biological research with advanced technology, Regeneron works on biologics and genetic medicines designed to address complex healthcare needs. The company also highlights health equity, environmental responsibility, scientific education, and ethical corporate practices as part of its broader mission to advance patient care.
Scientific Writer, Nonclinical PK/PD Regulatory
Regeneron is seeking a Scientific Writer to convert nonclinical pharmacokinetic, pharmacodynamic, and pharmacology data into regulatory documentation for drug development. The role includes preparing eCTD content and coordinating cross-functional development programs in a remote United States position.
Description
- Prepare nonclinical PK/PD study reports, eCTD summaries, and Investigator’s Brochure content independently.
- Develop integrated regulatory narratives from pharmacokinetic, pharmacodynamic, and mechanistic data.
- Partner with scientists and cross-functional teams to interpret findings and maintain consistent PK/PD messaging.
- Manage data collection, reviews, schedules, and stakeholder communications to deliver accurate work on time.
- Improve writing processes through guidance, workflow refinement, and AI-supported authoring and quality control.
- Lead scientific writing for assigned programs, including document strategy and cross-functional coordination.
- Present complex nonclinical PK/PD and pharmacology findings as clear regulatory narratives that support development and regulatory decisions.
Requirements
- Bachelor’s degree in a life sciences field.
- An MS or PhD is preferred.
- Relevant scientific and regulatory writing experience supporting nonclinical development programs.
- Experience working with laboratory-generated pharmacology, pharmacokinetic, or pharmacodynamic data within a nonclinical drug development team.
- Understanding of drug development, eCTD guidance, and ICH, FDA, and EMA/CHMP nonclinical requirements, including Modules 2.4, 2.6, and 4.
- Experience with document authoring, review, and collaboration tools in a regulated setting.
- The recruitment process may include background checks.
- Be prepared to provide identity, work authorization, and education verification when requested.
Benefits
- Annual bonuses or other incentive compensation.
- Equity awards.
- Pension or retirement benefits.
- 401(k) employer matching.
- Health and wellness programs.
- Access to fitness centers.
- Medical, dental, vision, life, and disability insurance.
- Paid time off.
- Family support programs.
- Reasonable accommodation during recruitment when needed.
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