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. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world’s largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we’ve built a promising pipeline centered around our core therapeutic areas.
Post : Medical Writing Associate I
Job Description
• Prepare 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.
• 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.
• Project lead when assigned
Candidate Profile
M.Sc, M.Pharm
Candidate must have Medical writing exposure
Additional Information
Qualification : M.Sc, M.Pharm
Location : Navi Mumbai
Industry Type : Pharma
Functional Area : Research & Development
End Date : 28th February, 2023
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