Medical Writer / Clinical Doc Author at micro1

Medical Writer / Clinical Document Author | $50–80/hr | Worldwide Remote

Join MICRO1 as a contract Medical Writer specializing in clinical documentation and regulatory submissions. This role is ideal for a detail-oriented specialist with deep expertise in regulatory medical writing, oncology, and haematology who thrives in a collaborative, AI-assisted environment.

Key Responsibilities

• Author and review Clinical Study Reports (CSRs) in accordance with ICH E3 guidelines
• Interpret clinical protocols and translate complex data into clear, accurate scientific documentation
• Perform source data verification and assess scientific accuracy across clinical documents
• Analyze Tables, Figures, and Listings (TFLs) to support regulatory submissions
• Contribute to periodic safety documentation following ICH E2F and ICH E2C standards
• Apply knowledge of eCTD (Electronic Common Technical Document) structure and requirements
• Evaluate AI-assisted documentation outputs and provide structured, actionable feedback
• Collaborate cross-functionally with clinical, regulatory, and data teams to resolve documentation challenges

Required Skills & Expertise

• Proven experience in regulatory medical writing and clinical document authoring
• Strong command of ICH E3, ICH E2F, and ICH E2C guidelines
• Proficiency in TFL analysis and clinical protocol interpretation
• Domain expertise in oncology and/or haematology
• Familiarity with eCTD submission frameworks
• Excellent written communication and structured feedback skills
• Comfortable working with AI-assisted documentation tools

This is a fully remote contract opportunity open to qualified candidates worldwide. Compensation ranges from $50 to $80 per hour based on experience and qualifications.