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

Skills Required