SUMMARY/POSITION OBJECTIVE:
The Director, Medical Coding will provide strategic leadership in designing and executing a comprehensive coding strategy that supports Regeneron’s clinical development portfolio. This role will be responsible for establishing new coding processes, workflows, governance, as well as coding dictionary management including MedDRA and WHO Drug with version control and change management to ensure accurate, consistent, and inspection ready coding practices aligned with regulatory requirements. The Director, Medical Coding will oversee all coding activities within Regeneron and/or performed by CRO partners, ensuring consistency and adherence to established conventions and timelines. The Director, Medical Coding will optimize operations through technology and evaluate AI-assisted solutions while building a scalable infrastructure that improves efficiency, quality, and cross-functional alignment.
JOB DUTIES:
- Design and execute on the medical coding strategy to support the clinical development portfolio, ensuring timely delivery aligned with clinical and safety milestones.
- Lead and scale coding operations by building a high-performing team and implementing standardized and efficient coding workflows to support portfolio growth.
- Design, implement, and continuously refine end-to-end medical coding processes to ensure consistency, scalability, quality control, in alignment with regulatory requirements and inspection readinesss.
- Provide strategic oversight of coding activities performed by CRO partners, establishing governance, performance metrics, and accountability to ensure quality and on-time delivery.
- Accountable for all medical coding, coding query management, quality of coding listings, ensuring accurate and consistent MedDRA and WHO Drug assignments per study conventions and SOPs.
- Responsible for developing and governing therapeutic area specific coding conventions, aligned to MedDRA/WHO Drug.
- Responsible for governance, maintenance, and version control of coding dictionary source files.
- Accountable for coding dictionary lifecycle management, e.g, version upgrades, impact assessments, and change control.
- Accountable for governance, development, and maintenance of the synonym framework, including synonym and Do Not Code lists.
- Responsible for search groupings (SMQs/CMQs or SDGs/CDGs) or FMQs (FDA Medical Queries).
- Accountable for and contribute to the set up & configuration of coding dictionaries in EDC, including UAT.
- Accountable for legacy data recoding strategies to support pooled analyses, e.g, ISS ensuring consistent terminology, traceability, and regulatory pooled datasets.
- Responsible for submitting / tracking change requests to MSSO for dictionary updates.
- Serve as the subject matter expert on the medical coding process, standards, and industry best practices, advising leadership and cross-functional teams.
- Collaborate with clinical data management teams, functional line management, and cross-functional teams to align priorities, streamline workflows, optimize resource allocation, and drive successful delivery of coding objectives.
- Develop and deliver training or knowledge-sharing programs to ensure consistent application of coding standards, strengthen organizational expertise, and support inspection readiness.
- Evaluate, and as applicable, lead adoption of AI-assisted coding and automation technologies to enhance efficiency, scalability, and quality.
- Ensure inspection readiness and regulatory compliance of coding documentation, contribute to internal audits and health authority inquiries.
- Establish and monitor coding KPIs to track performance, conformance to coding standards, and identify opportunities to enhance and/or optimize coding capabilities.
- Responsible for line management and performance of Clinical Data Management Coding staff, development of competencies, assessment of annual performance.
- Responsible for resource planning and allocation. Balance capacity and skills to meet priorities, monitor workload and utilization, proactively redistribute work, escalate constraints, and implement corrective actions to maintain delivery timelines.
- Provide leadership and mentorship to coding staff, fostering skill development, knowledge sharing, and operational excellence.
- Author and contribute to the development of clinical data management coding SOPs, WIs and departmental training needs.
- Lead and/or participate in cross-functional initiatives requiring medical coding expertise.
JOB REQUIREMENTS:
- Leadership experience in Clinical Data Management Medical Coding, developing strategies, workflows, and scalable operational processes.
- Expert in clinical data management coding processes, industry best practices, and clinical data systems (EDC).
- Expert knowledge of medical coding modules within clinical data systems (e.g., Medidata Rave Coding) including configuration, workflow design, and integration with safety and clinical data systems.
- Expert knowledge in MedDRA and WHO Drug dictionaries, including coding conventions and governance practices.
- Expert knowledge in coding dictionary management including upversioning, change management, and harmonization across the portfolio.
- Experience in overseeing CROs performing medical coding.
- Advanced knowledge of clinical data management principles, technologies, regulations and best practices, including 21 CFR Part 11, ICH-GCP Guidelines, GxP compliance and GDPR, related to data acquisition, processing, handling and reporting used in drug development.
- Healthcare business acumen with a comprehensive understanding of the pharmaceutical industry.
- Demonstrated success in solving complex business problems with strategic thinking.
- Ability to build relationships with key internal and external stakeholders at leadership levels and across levels by negotiating effectively, managing conflicts, escalations and collaborating successfully.
- Proven ability to establish highly motivated and performing teams
- Excellent interpersonal, oral, and written communication skills.
- Ability to adjust in a fast-paced environment.
- May require up to 25% travel.
Required Licenses & Certificates: Bachelor's Degree required & Advanced Degree Preferred
Bachelor's Degree required, Advanced degree desirable.
• 12+ years of clinical data management experience in a pharmaceutical or biotech setting.
• 5+ years of functional leadership
• 4+ years people management, leadership and mentoring experience
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
$183,100.00 - $305,200.00
