Sr. Manager, Medical Coding

Regeneron India Private Limited; Hyderabad; Hybride; INR 2 800 000 - 4 200 000; Plein temps

Avantages offerts par ce poste

Annual bonuses

Equity awards

Pension benefits

401(k) match

Health programs

Fitness centers

Insurance benefits

Paid time off

Family support

Résumé du poste

Regeneron India Private Limited is seeking a Sr. Manager, Medical Coding in Hyderabad (hybrid) to lead coding activities within our Clinical Data Management organization.

You will supervise internal and CRO teams, ensure MedDRA/WHODrug coding quality, and maintain governance frameworks with a strong focus on regulatory compliance and data integrity. The role emphasizes leadership, SOP development, and continuous improvement across CDM functions.

Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, Nursing or related healthcare field.
• 8+ years in biotech/pharma or health industry with 5–7 years direct Medical Coding experience.
• 3+ years of people management experience, leading Medical Coding teams and operations preferred.
• Extensive experience leading Medical Coding within Clinical Data Management, including CRO oversight.

Responsabilités

• Lead and oversee medical coding activities supporting the clinical development portfolio.
• Oversee internal and CRO-delivered coding activities, including study setup, UAT, coding assignments, query management, and SAE reconciliation.
• Develop and maintain coding conventions and governance; ensure compliance with regulatory requirements (21 CFR Part 11, ICH-GCP, GxP, GDPR).
• Drive process improvements, SOPs, and governance; support automation and AI-assisted coding where appropriate.

Connaissances

People management

Medical coding

Regulatory compliance

Cross-functional collaboration

Quality assurance

Communication

Formation

Bachelor's degree in Pharmacy/Life Sciences/Nursing or related healthcare field

Outils

MedDRA/WHODrug dictionaries

Medidata Rave Coder

Description du poste

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 those with serious diseases. In doing so, we are pioneering innovative approaches to science, manufacturing, and commercialization, as well as redefining our understanding of health. At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Sr. Manager, Medical Coding to join our Clinical Data Management organization. In this role, you will lead and oversee medical coding activities supporting our clinical development portfolio, ensuring accurate, consistent, and compliant coding of clinical data using MedDRA and WHODrug dictionaries. You will oversee internal and CRO-delivered coding activities, manage coding dictionary lifecycle and governance, drive continuous process improvements, and collaborate with cross-functional teams to deliver high-quality, inspection-ready clinical data.

When & where: Hyderabad (hybrid)

Discover your role:

• Implement the medical coding strategy and execute operational plans in alignment with Data Management objectives, regulatory requirements, and organizational priorities.
• Ensure accurate, consistent, and timely coding of clinical data using MedDRA and WHODrug dictionaries, in accordance with company standards, study-specific conventions, and regulatory requirements.
• Oversee medical coding activities performed internally and by CRO partners, including study setup, UAT, coding assignments, query management, synonym management, SAE reconciliation, and review of coding deliverables.
• Perform and review medical coding activities, as required, for high-priority studies, complex coding scenarios, quality reviews, and issue resolution.
• Develop, maintain, and ensure consistent application of therapeutic area and study-specific coding conventions.
• Support search groupings such as SMQs, CMQs, FMQs, SDGs, and CDGs to facilitate identification of adverse events of special interest and prohibited medications.
• Monitor coding quality, timelines, metrics, and KPIs, taking appropriate action to address risks and opportunities for improvement.
• Oversee the implementation, maintenance, and governance of MedDRA and WHODrug dictionaries, including version upgrades, impact assessments, change control, recoding activities, and maintenance of source files.
• Manage legacy data recoding activities to support pooled analyses, integrated summaries, and regulatory submissions.
• Serve as a subject matter expert for Medical Coding, providing guidance on coding processes, dictionaries, standards, and industry best practices.
• Lead continuous improvement initiatives and support the evaluation and implementation of automation and AI-assisted coding solutions, where appropriate.
• Maintain inspection readiness through compliant coding documentation and provide support during audits, inspections, and health authority inquiries.
• Author and maintain Medical Coding SOPs, work instructions, guidance documents, and training materials, while delivering training and knowledge-sharing activities.
• Manage and develop Medical Coding staff through performance management, coaching, mentoring, competency development, resource planning, and workload management.

This role requires:

• Bachelor's degree in Pharmacy, Life Sciences, Nursing, or a related healthcare field.
• 8+ years of experience in the biotechnology, pharmaceutical, or health-related industry, including 5–7 years of direct Medical Coding experience.
• Minimum 3 years of people management experience, with demonstrated experience leading Medical Coding teams and coding operations strongly preferred.
• Extensive experience leading Clinical Data Management Medical Coding activities, including oversight of coding operations, processes, personnel, and CRO-delivered coding activities.
• Strong hands-on and review experience using MedDRA and WHODrug dictionaries, along with excellent knowledge of medical and medication terminology.
• Advanced knowledge of medical coding systems within clinical data management platforms such as Medidata Rave Coder, including coding workflows, configuration, and integration with clinical and safety systems.
• Demonstrated experience implementing and improving operational processes, SOPs, work instructions, and governance frameworks supporting Medical Coding operations.
• Advanced knowledge of Clinical Data Management principles, technologies, and applicable regulations, including 21 CFR Part 11, ICH-GCP, GxP, and GDPR.
• Strong understanding of clinical development processes and cross-functional interactions, with the ability to solve complex operational challenges and drive continuous improvement.
• Proven leadership capabilities, including people management, coaching, mentoring, performance management, and talent development.
• Excellent interpersonal, verbal, and written communication skills, with the ability to collaborate effectively with senior leadership, cross-functional teams, CROs, and external vendors.
• Ability to manage competing priorities and organizational complexity and lead effectively through change while maintaining a strong focus on quality, compliance, and delivery.

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.

Benefits

• 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
• family support benefits

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.

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 JUST companies in 2020, among others.