Sr. Specialist, Medical Coding

Regeneron Pharmaceuticals, Inc.; Hyderabad; In loco; INR 1.800.000 - 2.400.000; Tempo pieno

Descrizione del lavoro

Regeneron Pharmaceuticals, Inc. in Hyderabad is seeking a Senior Specialist, Medical Coding to independently manage coding across studies and guide junior staff.

The role requires expertise with MedDRA/WHODrug dictionaries and Rave Coder, ensuring accurate, timely coding and collaboration with cross-functional teams. You will develop Medical Coding Plans, support study setup and database lock, review coding configurations and reports, and mentor others while advancing process improvements and

Competenze

• Bachelor's degree in Pharmacy, Life Sciences, Nursing, or related field.
• At least 5 years of medical coding experience in biotech, pharmaceutical, CRO, or health industry.
• Strong hands-on experience with MedDRA and WHODrug dictionaries, including conventions and version upgrades.
• Experience with Medidata Rave Coder and coding workflows.
• Knowledge of regulatory requirements (21 CFR Part 11, ICH-GCP, GDPR).
• Ability to manage multiple studies with minimal supervision.
• Mentor junior staff and drive process improvements, including automation, where appropriate.
• Strong analytical, communication, and stakeholder management skills.

Mansioni

• Independently manage medical coding activities for assigned studies and serve as the main contact for coding questions.
• Perform and review coding using MedDRA and WHODrug dictionaries.
• Develop Medical Coding Plans and support study setup within coding systems.
• Review coding CRFs, data collection standards, and reports for accuracy.
• Support dictionary version upgrades, synonym maintenance, 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 others to resolve issues.
• Identify data quality risks and ensure deliverables within timelines.
• Mentor junior staff and contribute to automation tools and AI-enabled coding solutions.

Conoscenze

MedDRA/WHODrug coding

Medidata Rave Coder

Regulatory knowledge

Mentoring/leadership

Formazione

Bachelor's degree in Pharmacy/Life Sciences

Strumenti

MedDRA dictionary

WHODrug dictionary

Descrizione del lavoro

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.

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.

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. 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. 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.