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Senior Specialist, External Data Acquisition and Delivery

RegeneronRegeneron·Biotechnology

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Posted

2 days

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About the role

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.

We are seeking a Senior Specialist, External Data Acquisition and Delivery to join our Clinical Data Management team. In this role, you will manage non-Case Report Form data across assigned studies or Clinical Development Units while collaborating with external data vendors, CRO partners, Clinical Data Management and cross-functional stakeholders. This position offers the opportunity to strengthen data integrity, improve external data delivery and support compliant study execution.

When & where:

Hyderabad (hybrid)

Discover your role:

  • Manage end-to-end non-Case Report Form data delivery.
  • Develop Data Transfer Specifications for assigned studies.
  • Reconcile external vendor data against clinical database outputs.
  • Partner with vendors to resolve data structure issues.
  • Track specifications, milestones and deliverables across programmes.
  • Support external data locking, archival and inspection readiness.
  • You guide cross-functional teams with clear technical direction.
  • You improve processes while maintaining quality and compliance.

This role requires:

  • Bachelor’s degree in Science, Health, Mathematics, Engineering, Computational or related field.
  • 5+ years in external clinical data acquisition or management.
  • Experience managing clinical data types such as biomarker, eCOA, imaging, ECG, PK, genomics and laboratory data.
  • Knowledge of 21 CFR Part 11, ICH-GCP and CDISC standards.
  • Proficiency extracting data into SAS, CSV and XML formats.
  • Experience with electronic data capture platforms and external data reconciliation processes.


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.

Skills & Tags

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Aplyr's read

Regeneron Pharmaceuticals is a biotechnology leader focused on innovative medicines for serious diseases, attracting talent in scientific, regulatory, and commercial roles.

Synthesized from recent postings & public sources

What's promising

  • Regeneron is at the forefront of biotechnology with a strong pipeline of innovative medicines.
  • The company offers diverse roles across scientific, regulatory, and commercial functions, indicating robust growth.
  • Regeneron's commitment to R&D is evident in its substantial investment in cutting-edge technologies.

What to watch

  • The competitive biotechnology field requires constant innovation, posing sustainability challenges.
  • Regeneron's success heavily depends on regulatory approvals, which can be unpredictable.
  • The company faces significant competition from other biotech firms in drug development.

Why Regeneron

  • Regeneron has a distinctive focus on antibody-based medicines, setting it apart in the biotech industry.
  • The company is renowned for its proprietary VelociSuite technologies, enhancing drug discovery.
  • Regeneron's collaborative culture fosters innovation and cross-disciplinary teamwork in drug development.

Aplyr’s read is generated by AI from public sources. Was it useful?

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About Regeneron

Regeneron Pharmaceuticals is a leading biotechnology company that discovers, develops, and commercializes innovative medicines for serious diseases.

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