Medical Writer
About the Role
Roles & Responsibilities
• Write, review, and edit clinical regulatory documents
• Prepare clinical study protocols and clinical study reports (CSRs)
• Develop Investigator’s Brochures, ICFs, CRFs, and related documents
• Ensure documents comply with ICH-GCP and regulatory guidelines
• Coordinate with clinical, regulatory, and cross-functional teams
• Maintain accuracy, consistency, and timelines for document delivery
• Incorporate reviewer comments and quality checks as required
Qualification
• Life Sciences / Pharmacy / Medical postgraduate or equivalent
• Strong academic background in clinical research or medical writing
Experience
• Minimum 5 years of hands-on experience in medical writing
• Proven experience with regulatory and clinical documentation
Skills
• Excellent scientific writing and editing skills
• Strong knowledge of ICH-GCP and regulatory standards
• Attention to detail and document quality control
• Ability to manage multiple projects and deadlines
• Good communication and stakeholder coordination skills
About the Organization
CliniExperts Research Services is a global clinical research organization providing end-to-end clinical trial, regulatory, and medical writing services, committed to quality, compliance, and innovation in clinical research.
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