Senior Medical Writer

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🏥📝 Medical Writer

🦅 H1B Visa Sponsor

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Logo of Regeneron

Regeneron

10,000+ employees

Founded 1988

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

💰 Post-IPO Equity on 2023-10

Biotechnology • Pharmaceuticals • Healthcare Insurance

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

• Author clinical study reports (CSRs), protocols, informed consent forms (ICFs), narratives, investigator brochures, and other regulatory documents across therapeutic areas • Represent Medical Writing at meetings, drive document development, and articulate strategy and timelines • Identify the right parties for content decisions and synthesise discussions into clear, accurate prose • Review work of junior or outsourced writers and CSR-related documents like Statistical Analysis Plans and TFLs • Write plain-language content such as ICFs and explain complex medical concepts to lay audiences • Adhere to applicable guidelines, templates, SOPs, and internal training while contributing to process improvement across Medical Writing and Global Development • Mentor junior staff, manage multiple priorities, and foster collaboration to resolve conflict

🎯 Requirements

• Bachelor's degree required; advanced degree preferred • Minimum 3 years of medical writing experience, including working knowledge of biostatistics • Strong knowledge of the clinical research process and applicable regulations, including ICH GCP • Clinical document reading, writing, and editing experience • Strong knowledge of MS Word, Adobe Acrobat, PowerPoint, and electronic document management systems • Ability to manage multiple projects with strong organisational, interpersonal, and communication skills

🏖️ Benefits

• annual bonuses or other incentive plans • equity awards • pension or retirement benefits • 401(k) company match • health and wellness programs • fitness centers • insurance benefits (e.g. medical, dental, vision, life and disability) • paid time off • family support benefits

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