Join to apply for the Senior Medical Writer role at Regeneron . The Senior Medical Writer (SMW) works with team members and independently to write clinical documents, including CSRs, protocols, ICFs, narratives, and IBs across various therapeutic areas. Opportunities to contribute to other regulatory documents may be available. The SMW tracks their projects, adheres to regulatory guidelines and departmental standards, and may serve as a lead for a compound. They may review the work of junior or outsourced writers and CSR-related documents to ensure content accuracy. Key Responsibilities: Collaborate with the clinical team to develop clinical documents and other regulatory materials. Represent Medical Writing at meetings, driving document development and articulating strategies and timelines. Participate in process improvements and working groups within Global Development. Review work of junior and outsourced writers, ensuring quality and compliance. Write in plain language to explain complex medical/scientific concepts. Mentor junior staff and ensure adherence to guidelines, templates, and SOPs. Remain aligned with internal training programs. Minimum Qualifications: Bachelor's degree (advanced degree preferred). At least 3 years of relevant Medical Writing experience, including knowledge of biostatistics. Understanding of clinical research processes and regulations. Experience reading, writing, and editing clinical documents. Strong organizational and communication skills. Proficiency with MS Word, Adobe Acrobat, PowerPoint, and electronic document management systems. Ability to manage multiple projects efficiently. Familiarity with ICH GCP guidelines. Apply now to start your journey with Regeneron! We offer an inclusive culture with comprehensive benefits, including health programs, fitness centers, bonuses, and paid time off. #J-18808-Ljbffr Regeneron
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