Posted:2 weeks ago|
Platform:
Work from Office
Full Time
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. 6 Providing exclusive literature search for products under evaluation for deciding strategies 7 Provide support for literature search/ data required for statistical analysis 8 Provide support for evaluation of 505(b)(2) applications, creating clinical development strategy and plans for FDA, EMA, PMDA etc. 9 Preparing/Providing support for clinical designs in light of current knowledge /strategies 10 Able to mentor team and guide clinical development strategy, medical monitoring and biostatistical activities Work Experience 4-6 years Education Graduation in Medicine or Medicine Post Graduation in Pharmacology or Pharmacology Competencies
Lupin
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