Posted over 30 days ago. Roles like this often stay open for a while, so it's still worth applying.
Medical Writer / Clinical Doc Author at micro1
posted 3 months agoMedical 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.