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 Specialist, Medical Coding to join our Clinical Data Management team. In this role, you will support the accurate, consistent, and timely coding of clinical trial data using MedDRA and WHODrug dictionaries. You will work with study teams and cross-functional partners to review and reconcile coded data, support study milestones, and help deliver high-quality, inspection-ready clinical data.   When & where:  Hyderabad (hybrid)  Discover your role:  • Perform medical coding for assigned studies using MedDRA and WHODrug dictionaries in line with company conventions, study requirements, and established procedures.  • Review auto-coded and manually coded terms to support coding accuracy, consistency, and quality.  • Contribute to Medical Coding Plans and support coding-related study setup activities within medical coding systems.  • Work with EDC Programmers and study teams to implement coding requirements in clinical systems.  • Assist with testing and validating coding configurations and reports.  • Maintain study-specific coding documentation and apply relevant coding conventions and guidelines.  • Support coding reconciliation between Clinical Data Management and Drug Safety.  • Collaborate with Clinical Data Managers, Medical Monitors, Clinical Scientists, Drug Safety, Biostatistics, CROs, and other partners to resolve coding issues and queries.  • Identify coding issues, data quality concerns, and study risks, and escalate them when needed.  • Support database lock activities and ensure coding documentation and milestone deliverables are inspection-ready.  • Participate in the evaluation and improvement of medical coding systems, automation tools, and AI-assisted coding solutions.  • Contribute to process improvements, training, and knowledge-sharing activities. This role requires:  • A bachelor's degree in Pharmacy, Life Sciences, Nursing, or a related healthcare field.  • At least 2 years of medical coding experience within biotechnology, pharmaceutical, CRO, or a health-related industry.  • Experience performing clinical data management medical coding using MedDRA and WHODrug dictionaries.  • Working knowledge of MedDRA and WHODrug conventions, hierarchy structures, and coding practices.  • Working knowledge of medical coding systems such as Medidata Rave Coder.  • Strong knowledge of medical and medication terminology within clinical development.  • Experience supporting study setup, coding documentation, coding queries, and coding quality reviews.  • Familiarity with coding reconciliation between Clinical Data Management and Drug Safety.  • An understanding of clinical development processes and cross-functional interactions.  • Basic knowledge of 21 CFR Part 11, ICH-GCP, GxP, GDPR, and applicable regulatory requirements.  • Strong analytical, organizational, problem-solving, communication, and attention-to-detail skills.  • The ability to manage assigned deliverables, meet study timelines, and collaborate with cross-functional teams and external partners.  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 c

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