Medical Writer - Clinical Trial

Write, review, and edit clinical trial documents, including but not limited to :

• Clinical Study Protocols and their appendices
• Case Record Forms (CRF)
• Informed Consent Documents (ICD)
• Patient Information Sheets (PIS)
• Investigator's Brochures (IB)
• Clinical Study Reports (CSR)
• Manuscripts and regulatory submission documents (e.g., IND, NDA, BLA, CTA modules)

Conduct literature reviews and extract relevant data from scientific databases for assigned projects.

Perform final quality control checks, formatting, tabulation, and pagination before finalizing documents.

Ensure compliance with ICH guidelines, Good Clinical Practice (GCP), and applicable regulatory standards.

Incorporate feedback from internal and external stakeholders accurately and promptly.

Maintain version control and manage documentation using project tracking systems.

Contribute to the creation and improvement of templates, style guides, and standard operating procedures (SOPs) for medical writing.

Provide quality control (QC) support for documents prepared by team members.

Participate in internal and external audits and inspections, as required.

Skills Required

literature reviews, style guides, Templates, manuscripts