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 civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.