Job opportunity as Medical Writing Associate at Teva-Apply before 30th May 2024

Medical Writing Associate I

Job Description:

• Coordinate with all concerned departments to ensure timelines and compliance with regulatory/sponsor requirements for the preparation, compilation, and delivery of reports.
• Prepare study reports for CE/PK studies and Brand studies.
• Address medical writing-related sponsor queries.
• Generate amended reports and amendments to the CSR as needed.
• Electronically generate, review study documents, and submit study reports in CTD/eCTD format according to regulatory requirements.
• Optionally provide coding for all adverse events recorded in the study using the MedDRA® coding system for clinical trials.
• Prepare protocols and related documents for BA/BE, clinical endpoint, and phase trials following ICH GCP and applicable regulatory requirements. Conduct literature search and review for the molecule under investigation.
• Prepare Informed Consent Documents, study-specific documents, and other appendices related to the protocol.

Candidate Profile:

• 3-5 years of experience in writing reports/technical operations.
• M.Sc/M.Pharm qualification.

Additional Information:

• Experience: 3-5 years
• Qualification: M.Sc/M.Pharm
• Location: Navi Mumbai
• Industry Type: Pharma/Healthcare/Clinical Research
• Functional Area: Medical Writing
• End Date: 30th May 2024
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