Senior Research Scientist- Medical Research

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