SRI LAKSHMI SOWJANYA SINGAM

Impact & Delivery (Scale & Consistency)

• Independently delivered 100+ regulatory QC projects (1,500+ pages) across Phase I–IV clinical programs, significantly strengthening quality, consistency, and throughput under aggressive timelines.
• Led QC for a broad portfolio of complex deliverables, including 80 + Full CSRs, Abbreviated/Synoptic CSRs, NIS reports, and Interim Analysis reports, demonstrating strong ability to identify systemic risks at scale.
• Completed QC for 20+ High-Level Documents, including SCS, SCE, and Clinical Overviews (CO), ensuring strict compliance with HLD standards and regulatory expectations.
• Successfully completed HLD QC training and immediately applied learnings to cross-study summaries and integrated deliverables, improving narrative alignment, traceability, and inspection readiness.

Quality, Compliance & Risk Management

• Applied rigorous HLD consistency checks, SCP alignment, and cross-document traceability, proactively identifying quality and compliance risks prior to escalation.
• Strengthened audit and inspection readiness through robust QC evidence trails, SOP adherence, and consistent application of regulatory standards.
• Reduced rework and review cycles through early risk identification, structured feedback, and corrective guidance to authors and stakeholders.

Collaboration, Stakeholder Engagement & Ways of Working

• Partnered closely with Medical Writing, Regulatory Affairs, Biostatistics, Publishing, and Program Teams to anticipate issues early, maintain transparent progress tracking, and ensure clean, on-time handoffs.
• Coordinated reviews across global teams and time zones, supporting uninterrupted program delivery and milestone achievement.
• Actively shared recurring QC insights and best practices to support standardization and collective capability building.

Learning, Mentorship & Leadership Influence

• Invested intentionally in continuous upskilling and domain depth, rapidly expanding expertise in HLD QC, complex summaries, and integrated clinical documents.
• Mentored peers on QC best practices, template usage, and error-prevention strategies, strengthening overall team quality and confidence.
• Acted as a go-to reviewer for complex summaries, supporting consistent delivery standards across programs.

Innovation, Continuous Improvement & Culture

• Contributed to CO-IN 2025 Hackathon and GEN-AI Hackathon 2025, collaborating cross-functionally to explore solutions improving quality, efficiency, and scalability.
• Embedded process-improvement thinking into daily QC work, implementing targeted enhancements such as refined checklists and stronger documentation evidence trails.
• Actively contributed to NOCC Hyderabad site culture through ERG initiatives (GENFLEX, Kartavya, Enliven Sports), supporting inclusion, well-being, and cross-team collaboration.

• Delivered 10+ postgraduate/PhD dissertations and 30+ academic research projects for international universities with 100% client satisfaction.
• Authored clinical literature reviews, case studies, and trial-aligned documents adhering to ICH-GCP and publication standards.
• Provided end-to-end project support including research, data interpretation, scientific writing, and formatting compliance.
• Delivered multilingual content (English, Telugu, Hindi) and SEO-optimized healthcare materials.

• Authored and QC-reviewed 800+ patient narratives across clinical trial and post-marketing settings, supporting global regulatory submissions.
• Independently managed pre- and post-DBL narratives across Oncology, Cardiology, Respiratory, and Nephrology.
• Processed 1,500+ ICSRs, including triage, MedDRA/WHO-DD coding, narrative drafting, reconciliation, and quality checks.
• Identified and resolved data discrepancies through cross-functional collaboration, reducing follow-up queries and rework.
• Served as an informal SME and mentor for junior writers, improving productivity, quality consistency, and regulatory alignment.
• Maintained 100% compliance with submission timelines across high-volume, parallel workloads.

• Maintained and audited raw material specifications, STPs, and DMS records in compliance with USFDA, EMA, and Indian regulatory standards.
• Supported CAPA and OOS investigations, contributing to root-cause analysis and preventive actions.
• Enabled successful regulatory inspections through accurate documentation control, traceability, and audit readiness.
• Coordinated with QA, Procurement, and Warehouse teams to ensure compliant documentation workflows.