Medical Writer (Pharmaceutical) at micro1

Medical Writer (Pharmaceutical) | $30–60/hr | Worldwide Remote

Join MICRO1 as a contract Medical Writer specializing in pharmaceutical and regulatory documentation. This role is ideal for a detail-oriented specialist with deep expertise in clinical and regulatory writing, particularly within oncology and haematology domains.

Key Responsibilities

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

Required Skills & Expertise

• Proven experience in regulatory medical writing within the pharmaceutical industry
• Strong knowledge of ICH E3, ICH E2F, and ICH E2C guidelines
• Familiarity with eCTD structure and regulatory submission standards
• Domain expertise in oncology and/or haematology
• Excellent written communication and structured feedback skills
• Experience with AI-assisted documentation evaluation is a plus
• Strong collaborative problem-solving abilities

This is a fully remote contractor engagement open to qualified candidates worldwide. Compensation ranges from $30 to $60 per hour based on experience and expertise.