Job description Job Description 1 Review of Study related documents (Protocol, IB, ICD, SAPs, Tables, Listings, Figures (TLFs), medical coding reports, CSR, etc. ) 2 Review of mock and final TFLs, AE/SAE data, clinical study reports 3 Preparation of regulatory briefing books, submission dossiers, etc. 4 Provide/support responses for Site/EC/Regulatory queries for ongoing clinical development products 5 Assessment of protocol deviations, assessment of ongoing safely and efficacy data, evaluation of SAEs, training of the operations team on therapy area and protocol etc. read more Key Skills TrainingStatistical analysisLiteratureCSRMedical codingclinical developmentMentorPharmacologyResearchMonitoring
Job Summary
Company
Lupin
Location
Pune
Experience
4-6 Yrs
Verification
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