Scientific Writer
Regeneron
9 hours ago
On-site
United States
Clinical Research and Development
Responsibilities:
- Draft and manage reviews of nonclinical pharmacology and toxicology submission documents across therapeutic areas.
- Work with scientists, Research Program Management, and Regulatory Affairs to interpret data and develop key messaging for drug candidates.
- Independently author and manage internal reviews of nonclinical study reports, eCTD summary documents, and Investigator’s Brochures.
- Reconcile comments and drive consensus among stakeholders up through Senior Management.
- Manage multiple projects while meeting submission target timelines.
- Improve processes by creating/revising internal guidance and templates or implementing new technology solutions.
- Train and support consultants or junior writers in the Scientific Writing group.
Qualifications/Requirements:
- BS or MS with 6+ years, or PhD in a Life Sciences-related field with 2+ years relevant experience (e.g., scientific/regulatory writing or pharmaceutical industry).
Preferred/Required Skills:
- Experience with eCTD and the drug development process.
- Strong attention to detail, time-management skills, and scientific rigor.
- Proficiency with Word, Excel, Adobe, and GraphPad Prism.
- Basic, job-relevant AI experience.
- Fluent in English.
Benefits:
- Comprehensive benefits (varies by location): medical, dental, vision, life, and disability insurance; fitness centers; 401(k) match; equity awards; annual bonuses; paid time off and paid leaves.
Application Instructions:
- Submitting a cover letter is strongly encouraged. Apply now.
- Draft and manage reviews of nonclinical pharmacology and toxicology submission documents across therapeutic areas.
- Work with scientists, Research Program Management, and Regulatory Affairs to interpret data and develop key messaging for drug candidates.
- Independently author and manage internal reviews of nonclinical study reports, eCTD summary documents, and Investigator’s Brochures.
- Reconcile comments and drive consensus among stakeholders up through Senior Management.
- Manage multiple projects while meeting submission target timelines.
- Improve processes by creating/revising internal guidance and templates or implementing new technology solutions.
- Train and support consultants or junior writers in the Scientific Writing group.
Qualifications/Requirements:
- BS or MS with 6+ years, or PhD in a Life Sciences-related field with 2+ years relevant experience (e.g., scientific/regulatory writing or pharmaceutical industry).
Preferred/Required Skills:
- Experience with eCTD and the drug development process.
- Strong attention to detail, time-management skills, and scientific rigor.
- Proficiency with Word, Excel, Adobe, and GraphPad Prism.
- Basic, job-relevant AI experience.
- Fluent in English.
Benefits:
- Comprehensive benefits (varies by location): medical, dental, vision, life, and disability insurance; fitness centers; 401(k) match; equity awards; annual bonuses; paid time off and paid leaves.
Application Instructions:
- Submitting a cover letter is strongly encouraged. Apply now.