Posted over 30 days ago. Roles like this often stay open for a while, so it's still worth applying.
Medical Writer (Pharmaceutical) at micro1
posted 1 month agoMedical 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.