Job Description

Hi,

We are hiring for one of India's leading IT & consulting organizations for the position of Medical Writer.

Summary

Medical Writer create and edit clinical, regulatory, or marketing documentation in Italian, often translating complex scientific data into accurate, compliant content. They work on projects like regulatory submissions, patient education materials, and scientific articles. Key roles involve managing Italian terminology and ensuring adherence to local regulatory standards

• To Apply for above Medical Writer, WhatsApp 'Hi' @ 9519459922

• When Asked For The job Code, Type: Job Code # 121

Key skills:

• Minimum 4 years of experience in Medical Writing and Regulatory Writing for clinical and scientific documents
• Proficiency in Scientific Writing
• Experience in preparing Patient Narratives, Post-Approval Regulatory Documents across multiple Therapeutic Areas.
• Hands on experience in SAP and TLFs
• Any Graduate

Key Responsibilities:

• Prepare and review Clinical and Regulatory Documents, including Protocols, Clinical Study Reports (CSRs), Clinical Pharmacology Reports, Narratives, and Post-Approval Documents.
• Perform Quality Checks (QC) of regulatory submission documents to ensure accuracy, compliance, and completeness.
• Develop and review Clinical Summary of Safety (CSS), Clinical Summary of Efficacy (CSE), and Common Technical Document (CTD) Modules.
• Coordinate with Cross-Functional Study Teams and external stakeholders for document development and submission activities.
• Conduct Project Kick-off Meetings and document planning sessions with study teams.
• Manage Project Timelines and ensure timely delivery of submission-ready clinical documents.
• Ensure adherence to SOPs, Regulatory Guidelines, Document Standards, and ICH-GCP requirements.
• Review Statistical Analysis Plans (SAPs) and Tables, Figures & Listings (TFLs) for scientific accuracy and consistency.
• Maintain Scientific Accuracy, Consistency, and Data Integrity across all clinical and regulatory documents.
• Support Global Regulatory Submissions through high-quality Medical Writing and documentation

More Info

Education