Meena Kumari
Scientific Writer & Pharma Researcher @百时美施贵宝
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WORK HISTORY
Scientific Writer & Pharma Researcher @百时美施贵宝
Conducted literature searches using PubMed, Embase, and Cochrane library to support research on therapeutic areas.• Authored, edited, and reviewed Clinical Study Reports and regulatory documents, ensuring compliance with sponsor-driven requirements.• Ensured timely completion of clinical documentation, maintaining accuracy and adherence to corporate standards.• Collaborated with clinical, regulatory, statistics, and scientific teams within the sponsor company to optimize documentation workflows.• Actively participated in regulatory strategic and lean writing forums, contributing insights to optimize documentation processes and enhance regulatory efficiency.• Identified a key strategic insight regarding a product that had performed successfully for two indications but failed in the third - prepared and delivered a presentation detailing efficacy differences, safety data, and potential leverage points for the other two indications.• Prepared and delivered a presentation on this analysis, demonstrating how safety data could be leveraged to support continued marketing approval for the two successful indications.• Expanded beyond the traditional medical writer scope, offering scientific and strategic analysis that was highly appreciated by the team and management.
EDUCATION
Shanghai Jiao Tong University
Post Doctoral Fellow
Osmania University
MSc
Osmania University
Doctor of Philosophy (PhD)
ABOUT MEENA KUMARI
Scientific Business Analyst working at the intersection of biology, data, and technology,…
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