Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide.
Post : Medical Writing Associate I
Job Description
• Coordinate with all concerned department to ensure timelines and compliance to regulatory/sponsor requirements for preparation, compilation and delivery of reports.
• Preparation of study reports for CE/PK studies, Brand studies
• Attend to medical writing related sponsor queries.
• Prepare amended reports and amendments to the CSR when necessary.
• Electronically generate, review study documents and submission of study reports in CTD/eCTD format as per regulatory requirements.
• Providing coding for all adverse events recorded in the study as per MedDRA® coding system for clinical trials (optional).
• Preparation of protocol and related documents for BA/BE, clinical end point and phase trials in accordance with ICH GCP, applicable regulatory requirements. Literature search and review for the molecule under investigation.
• Preparation of Informed Consent Document, study specific documents and other appendices related to protocol.
Candidate Profile
• 3-5 years in writing reports/technical operations
• M.Sc / M.Pharm
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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