Sr. Specialist, Medical Coding

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About the role

Build our future together:  Regeneron is founded on the belief that the right idea, combined with the right team, can lead to significant transformations. Our growing global network is dedicated to inventing, developing, and commercializing medicines that change lives for people with serious diseases. We are seeking a Senior Specialist, Medical Coding to join our Clinical Data Management team. You will independently manage medical coding activities across assigned clinical studies using MedDRA and WHODrug dictionaries. You will help ensure accurate, consistent, and timely coding, support study setup and database lock activities, collaborate with cross-functional teams and CRO partners, and guide junior coding staff. When & where:  Hyderabad (hybrid)  Discover your role:  • Independently manage medical coding activities for assigned studies and serve as the main contact for study-level coding questions and issues.  • Perform and review coding using MedDRA and WHODrug dictionaries in line with company conventions and study requirements.  • Develop Medical Coding Plans and support study setup within medical coding systems.  • Review coding CRFs, data collection standards, coding configurations, and reports for accuracy and completeness.  • Support dictionary version upgrades, synonym maintenance, impact assessments, and recoding activities.  • Maintain study-specific coding guidelines and inspection-ready documentation.  • Perform coding reconciliation with Clinical Data Management and Drug Safety teams.  • Partner with Medical Monitors, Clinical Scientists, Drug Safety, Biostatistics, CROs, and other stakeholders to resolve coding issues.  • Identify data quality risks, escalate concerns, and complete coding deliverables within database lock timelines.  • Mentor junior staff and contribute to process improvements, automation tools, and AI-enabled coding solutions.   This role requires:  • A bachelor's degree in Pharmacy, Life Sciences, Nursing, or a related healthcare field.  • At least 5 years of medical coding experience within biotechnology, pharmaceutical, CRO, or a health-related industry.  • Strong hands-on experience with MedDRA and WHODrug dictionaries, including coding conventions, hierarchies, version upgrades, impact assessments, and recoding.  • Experience with medical coding systems such as Medidata Rave Coder, including coding workflows, study setup, configuration review, and report validation.  • Strong knowledge of medical and medication terminology and its use in clinical development.  • Experience developing Medical Coding Plans, reviewing coding CRFs, and supporting study setup and database lock activities.  • Experience with coding reconciliation between Clinical Data Management and Drug Safety.  • Working knowledge of 21 CFR Part 11, ICH-GCP, GxP, GDPR, and relevant regulatory requirements.  • The ability to independently manage multiple studies, priorities, and timelines with minimal supervision.  • Strong analytical, problem-solving, organizational, communication, and stakeholder management skills.  • The ability to mentor less-experienced staff and work effectively in a fast-paced, cross-functional environment.  Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all  qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, m

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