Sr. Manager, Medical Coding

About Regeneron

Role Overview

When and Where

• The role is based in Hyderabad and is described as hybrid.

Medical Coding Operations

• Implement the medical coding strategy and operational plans aligned with data management objectives, regulations, and organizational priorities.
• Ensure accurate, consistent, and timely coding using MedDRA and WHODrug.
• Oversee internal and CRO coding activities including study setup, UAT, assignments, queries, synonyms, SAE reconciliation, and deliverable review.
• Perform and review coding for priority studies, complex scenarios, quality reviews, and issue resolution.
• Maintain therapeutic-area and study-specific coding conventions.
• Support SMQs, CMQs, FMQs, SDGs, and CDGs for safety-event and prohibited-medication identification.

Governance and Improvement

• Monitor coding quality, timelines, metrics, and KPIs and address risks and improvement opportunities.
• Govern MedDRA and WHODrug upgrades, impact assessments, change control, recoding, and source-file maintenance.
• Manage legacy data recoding for pooled analyses, integrated summaries, and regulatory submissions.
• Lead continuous improvement and evaluate automation and AI-assisted coding solutions where appropriate.
• Maintain inspection readiness and support audits, inspections, and health authority inquiries.

Leadership and Documentation

• Serve as a Medical Coding subject matter expert and provide guidance on processes, dictionaries, standards, and best practices.
• Author SOPs, work instructions, guidance, and training materials and deliver training and knowledge sharing.
• Manage and develop staff through performance management, coaching, mentoring, competency development, resource planning, and workload management.

Required Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, Nursing, or a related healthcare field.
• At least 8 years of biotechnology, pharmaceutical, or health-related industry experience, including 5–7 years of direct Medical Coding experience.
• At least 3 years of people management experience.
• Extensive leadership experience in Clinical Data Management Medical Coding and oversight of CRO-delivered coding.
• Strong hands-on and review experience with MedDRA, WHODrug, and medical terminology.
• Advanced knowledge of Medidata Rave Coder and clinical data management coding workflows, configuration, and integrations.
• Experience with SOPs, work instructions, governance frameworks, Clinical Data Management, clinical development, and applicable regulations.
• Proven leadership, communication, prioritization, change management, and continuous improvement capabilities.