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Teva Medical Writing Associate II India, Maharashtra, Navi Mumbai 132983499
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How you’ll spend your day
- Prepare and review of CSR, appendices and other relevant documents (bio summary tables, module 2.7, CS-BE etc.) as per the regulatory/sponsor requirements in the required format.
- 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.
- Attend to medical writing related sponsor queries.
- Quality check of the final compiled study reports for delivery.
- Responsible for providing practical training to new recruits regarding the preparation of CSR, appendices and other relevant documents.
- Report to Lead Medical Writing-Reports.
- To carry out other responsibilities as and when assigned by management.
- System improvements as required on day-to-day basis as per business requirements.
- Mentor team and as assigned, act as subject matter expert (SME)
- Project lead when assigned
Your experience and qualifications
- Experience : 8+ years in writing reports/technical operations
- Qualification : M.Sc, M.pharm
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