Scientific Writer

🔥 1 minute ago

🇺🇸 United States – Remote

💵 $109.9k - $179.3k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

✏️ Content Writer

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Regeneron

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1988

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

💰 Post-IPO Equity on 2023-10

Healthcare • Manufacturing • Biotechnology

Regeneron is a biotechnology company dedicated to turning scientific discoveries into life-changing medicines. The company focuses on a range of serious diseases including allergic, cardiovascular, and metabolic diseases, neuroscience, oncology, hematology, ophthalmology, and rare diseases. It achieves this by integrating biology and technology to develop cutting-edge biologics and genetic medicines. Regeneron is committed to health equity, environmental sustainability, and supporting future STEM talent through initiatives like the Regeneron Science Talent Search. By maintaining high ethical standards and corporate responsibility, Regeneron aims to push the boundaries of science for better healthcare solutions.

📋 Description

• 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

• 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

• 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