Senior Research Scientist- Medical Research

Roles & Responsibilities
• Review clinical study–related documents including Protocols, Investigator’s Brochure (IB), Informed Consent Documents (ICD), SAPs, TLFs, medical coding reports, and Clinical Study Reports (CSR)
• Review mock and final Tables, Listings, and Figures (TLFs), adverse event (AE/SAE) data, and clinical study outputs
• Prepare regulatory briefing books, submission dossiers, and supporting medical documentation
• Provide medical and scientific responses to Site, Ethics Committee (EC), and Regulatory Authority queries for ongoing clinical development programs
• Assess protocol deviations, ongoing safety and efficacy data, and evaluate Serious Adverse Events (SAEs)
• Train and support clinical operations teams on therapy areas, protocols, and medical aspects of studies
• Conduct comprehensive literature searches to support product evaluation and clinical strategy development
• Provide medical and scientific inputs for statistical analysis and data interpretation
• Support evaluation of 505(b)(2) applications and contribute to clinical development strategies for FDA, EMA, PMDA, and other global regulators
• Support preparation and review of clinical study designs aligned with current scientific knowledge and regulatory expectations
• Mentor junior team members and guide clinical development strategy, medical monitoring, and biostatistical activities

Qualification
• Graduation in Medicine (MBBS or equivalent)
• Postgraduate qualification in Pharmacology preferred

Experience
• 4–6 years of experience in medical research, clinical development, or related pharmaceutical roles

Skills
• Strong understanding of clinical research and regulatory documentation
• Medical review of safety, efficacy, and clinical data
• Literature review and clinical strategy development
• Experience with global regulatory submissions
• Ability to mentor teams and collaborate cross-functionally
• Excellent scientific writing and communication skills

About the Organization
Lupin Biotech, part of the Lupin Group, is committed to advancing medical research and innovative healthcare solutions. The organization emphasizes scientific excellence, patient safety, and global regulatory compliance across its clinical development programs.