Clinical Documentation Specialist

1 day ago


Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 18,00,000 - ₹ 20,00,000
Job Title: Regulatory Documentation Specialist

Job Summary:
To write, review and manage the production of high quality clinical and safety documentation for submission to regulatory authorities in support of marketing applications.

Main Responsibilities:
• Author, review and independently manage high quality clinical and safety documents, including Clinical Study Reports (CSR), Risk Management Plans (RMP) and complex CTD submission documents.
• Lead writing team for complex submissions, actively contributing to key messaging and pooling strategy, providing expert content guidance for clinical portions of the CTD, and ensuring compliance of documentation to internal company standards and external regulatory guidelines.
• Provide content and strategic expertise for clinical portions of the CTD, input into planning of data analyses and presentation, statistical analysis plan review and meetings, used in CSRs, submission documents and/or answers to questions.
• Document expert in GCTs and CSTs to ensure compliance to internal company standards and external regulatory guidelines.

Required Skills and Qualifications:
• Clinical Research
• Clinical Trials
• Detail-Oriented
• Medical Writing
• People Management
• Project Management
• Regulatory Compliance
• Safety

Benefits:
Delivery of high quality clinical and safety documents in time and in compliance with internal and external standards. Customer, partner, project feedback and satisfaction. Adherence to Novartis policy and guidelines

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