Responsibilities:

• Write and edit regulatory documents, including CSRs, Safety Narratives, BLAs, NDAs, INDs, and investigator brochures
• Collaborate with cross-functional teams of medical writers, GenAI engineers client SMEs
• Opportunity to help shape the product workflows and UI
• Ensure compliance with relevant regulations, guidelines, and industry standards
• Conduct literature searches and summarize complex scientific data
• Develop and maintain templates, style guides, and standard operating procedures
• Stay up-to-date with industry trends, best practices, and emerging technologies

Requirements:

• Bachelor's degree in life sciences, English, or a related field
• Minimum 3-5 years of experience as a regulatory medical writer
• Proven portfolio of regulatory documents, including BLAs and NDAs
• Strong understanding of FDA and ICH guidelines, regulations, and industry standards
• Excellent writing, editing, and communication skills
• Ability to work independently and collaboratively in a fast-paced environment
• Strong attention to detail, organization, and project management skills
• Familiarity with AI-based tools and technology a plus

Nice to Have:

• Advanced degree (MS, Ph.D.) in life sciences or a related field
• Certification as a medical writer (e.g., AMWA, EMWA)
• Experience with GenAI-based tools and platforms
• Knowledge of data analytics and visualization

What We Offer:

• Competitive hourly rate
• Opportunity to work on innovative projects with cutting-edge AI technology
• Collaborative and dynamic work environment
• Potential to convert to a full-time employee (FTE) role
• Professional development and training opportunities

How to Apply: If you're a skilled and motivated regulatory medical writer looking for a new challenge, please submit your resume, cover letter, and portfolio to [email protected] . We can't wait to hear from you! Peer AI is a revolutionary GenAI-based medical writing company that harnesses the power of artificial intelligence to transform the life sciences regulatory writing process. Our team of experts is dedicated to delivering high-quality, compliant documents that meet the evolving needs of our clients. Join us in shaping the future of medical writing! #J-18808-Ljbffr Experience: 3 years required