job title: medical writer 1(icon)

What you will be doing

• Narrative Writing: Develop and write patient narratives.

• Data Interpretation: Summarize clinical data, ensuring it is presented clearly and accurately in the narrative, with attention to scientific and regulatory guidelines.

• Collaboration: Work closely with clinical research teams, biostatisticians, and medical monitors to ensure timely and accurate deliverables.

• Compliance & Standards: Ensure adherence to regulatory guidelines, company standards, and industry best practices in medical writing.

• Editing & Review: Review and edit documents for clarity, consistency, grammar, and formatting, ensuring they are ready for publishing with CSR.

• Documentation Management: Maintain version-controlled files and track progress in document preparation, ensuring deadlines are met.

Your profile

• At least 2-3 years of experience in narrative writing, specifically with clinical study reports (CSRs) and regulatory documentation.

• Strong understanding of clinical trial processes and regulatory requirements (e.g., ICH-GCP, FDA, EMA).

• Excellent written and verbal communication skills.

• Ability to interpret and present complex clinical data in a clear and concise manner.

• Familiarity with Microsoft Office Suite (Word, Excel, PowerPoint) and reference management software.

• Master’s degree in life sciences, pharmacy, or a related field; advanced degrees (e.g., MSc, PhD) are a plus.

• Experience with additional medical writing documents (e.g., clinical trial protocols, patient narratives, submission documents).