Senior Research Scientist- Medical Research
Lupin
4 - 6 years
Pune
Posted: 11/06/2025
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.
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
Competencies
About Company
Lupin Limited is a global pharmaceutical company based in Mumbai, India, specializing in generic and branded formulations, biotechnology products, and APIs. Founded in 1968, Lupin operates in over 100 countries and is known for its strong presence in therapeutic areas like cardiovascular, diabetes, respiratory, and anti-infectives. It is one of the top 10 generic pharma companies worldwide.
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