Specialist, Medical Coding

Regeneron India Private Limited; Hyderabad; On-site; INR 700,000 - 1,000,000; Full time

Benefits offered by this job

Bonus plans

Equity awards

Pension

401(k)

Health benefits

Paid time off

Family support

Wellness programs

Job summary

Regeneron India Private Limited is seeking a Specialist, Medical Coding to join its Clinical Data Management team in Hyderabad. You will code clinical trial data using MedDRA and WHODrug, review coded terms, and support study milestones to deliver inspection-ready data.

The role requires a Bachelor's in Pharmacy or Life Sciences, at least 2 years' medical coding experience, and knowledge of MedDRA/WHODrug conventions.

Qualifications

• 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 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.

Responsibilities

• 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 elevate 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.

Skills

Medical coding

MedDRA

WHODrug

Data quality

Regulatory knowledge

Communication

Education

Bachelor's degree in Pharmacy/Life Sciences/Nursing

Tools

Medidata Rave Coder

Job description

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.

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 elevate 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.

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.

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.

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.

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.

Regeneron is a leading biotechnology company that invents life‑transforming medicines for people with serious diseases. Founded and led for over 30 years by physician‑scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA‑approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories.

Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases.

Regeneron is also proud of award‑winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUS companies in 2020, among others.

For jobs in Canada: this posting is for an existing position.