Job Title: Senior Research Scientist – Medical Research
Location: Pune, Maharashtra, India
Company: Lupin
Employment Type: Full-Time
About the Role:
Lupin is seeking a highly skilled Senior Research Scientist – Medical Research with 4–6 years of experience in clinical research, medical monitoring, and regulatory support. The role involves leading clinical study document review, providing strategic medical insights, supporting regulatory submissions, and mentoring junior team members.
Key Responsibilities:
Review clinical study documents including Protocols, Investigator Brochures (IB), Informed Consent Documents (ICD), Statistical Analysis Plans (SAPs), Tables, Listings, Figures (TLFs), medical coding reports, and Clinical Study Reports (CSRs).
Review mock and final TFLs, Adverse Event (AE) and Serious Adverse Event (SAE) data, and CSRs to ensure accuracy and compliance.
Prepare regulatory briefing books, submission dossiers, and other documentation for Health Authorities.
Provide and support responses for Site, Ethics Committee (EC), and regulatory queries for ongoing clinical development products.
Assess protocol deviations, monitor ongoing safety and efficacy data, evaluate SAEs, and provide training to operations teams on therapy areas and protocol specifics.
Conduct literature searches to support product evaluation, clinical strategy development, and statistical analyses.
Support evaluation of 505(b)(2) applications and contribute to clinical development strategy and planning for regulatory agencies such as FDA, EMA, and PMDA.
Provide input for clinical study designs aligned with current knowledge and regulatory expectations.
Mentor and guide team members in clinical development strategy, medical monitoring, and biostatistical activities.
Required Experience & Skills:
4–6 years of experience in clinical research, medical monitoring, regulatory affairs, or pharmacology.
Strong knowledge of clinical study documentation, safety reporting, and regulatory submission requirements.
Expertise in literature search, clinical development strategy, and statistical data support.
Proven ability to mentor and guide junior team members.
Education:
Graduate in Medicine (MBBS) or equivalent.
Postgraduate in Pharmacology or equivalent.
Core Competencies:
Clinical research expertise and medical monitoring
Regulatory compliance and submission support
Analytical thinking and data interpretation
Mentorship and team leadership
Strategic planning and clinical development insight
Why Join Lupin:
Lead advanced medical research projects within a global pharmaceutical company.
Collaborate with cross-functional teams and regulatory agencies.
Opportunity to shape clinical strategies and contribute to innovative product development.
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