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RWE Specialist

Primary Location: United Kingdom, Remote Additional Locations: United Kingdom, Sheffield; United Kingdom, Harrow; United Kingdom, London; United Kingdom, Navigation House; United Kingdom, Uxbridge; United Kingdom, Worthing ID de la oferta R0000036434 Categoría Regulatory Affairs Fecha de publicación 11/03/2025
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Overview

Como parte de Consultoría de Parexel, cumplirá un rol vital al asistir a las empresas biofarmacéuticas y de dispositivos médicos a transitar el complejo y siempre cambiante entorno regulatorio. Respaldado por su experiencia científica, técnica y regulatoria, trabajará de cerca con los clientes para desarrollar e implementar estrategias regulatorias que colocarán sus medicamentos en el mercado con mayor rapidez y los mantendrán allí.

Valoramos la colaboración, la innovación y el aprendizaje continuo. Como miembro de nuestro equipo, se asociará con un grupo diverso de clientes y estará expuesto a diversos tipos de medicamentos y áreas terapéuticas. Asimismo, desarrollará sus habilidades a través de asignaciones desafiantes y con la mentoría de profesionales experimentados en asuntos regulatorios. Además, disfrutará de la flexibilidad de trabajar en modalidad remota, al tiempo que forma parte de un equipo colaborador y dinámico.

Perfil del éxito

¿Posee estas competencias sociales y rasgos interpersonales para tener éxito en Parexel?

  • Comunicador
  • Estratégico
  • Constructor de relaciones
  • Solucionador de problemas
  • Orientado al detalle
  • Impulsado por los resultados

Acerca de este rol

At Parexel, we believe in the power of real-world data to transform clinical research and improve patient outcomes. We are seeking a passionate and experienced RWE Specialist join our team and support the design and execution of clinical trials through advanced analytics and evidence generation. This role is ideal for someone who thrives in a collaborative, cross-functional environment and is driven by innovation and scientific rigor.

Title: RWE Specialist

Location: Remote – UK

Key Responsibilities

  • Understand and be familiar with the licensed RWD database(s) relevant to the organization’s clinical research initiatives
  • Independently identify, access, and assess in-house real-world data sources (EHRs, claims, registries, etc.) relevant to clinical trial populations and endpoints
  • Access and summarize non-patient-level real-world data (publications, aggregate claims or EHR analytics, federated learnings, external collaborations, etc.) relevant to clinical trial populations and endpoints
  • Critically evaluate data quality, completeness, and suitability for specific trial design questions
  • Develop RWD exploration plans
  • Clean, process, and harmonize raw RWD for analysis, applying data governance and privacy standards
  • Use SAS, R, Python and/or other advanced analytical programming tools to perform statistical analyses and generate insights on patient characteristics, treatment patterns, outcomes, and epidemiology
  • Prepare clear, concise evidence summaries and visual reports to inform protocol development (inclusion/exclusion criteria, endpoints, comparator selection, feasibility assessments, etc.)
  • Collaborate cross-functionally with clinical, regulatory, biostatistics, and medical teams to ensure alignment with study goals and timelines
  • Stay current on RWD methodologies, regulatory guidance, and technological advances in the field
  • Ensure all work supports timely, high-quality decision making for new clinical trial design and execution
  • Develop innovative RWD analytical tools to support evolving clinical trial needs
  • Conduct independent assessments of data sources to determine relevance, quality, and utility for real-world evidence generation
  • Incorporate input from internal subject matter experts (SMEs) to ensure alignment with RWE/RWD best practices and strategic objectives

Qualifications

  • Advanced degree in Epidemiology, Biostatistics, Public Health, or related field preferred
  • 3–5 years of relevant experience in real-world data analytics or related field
  • Proficiency in SAS, R, Python, and SQL
  • Experience working with healthcare data sources including EHRs, claims, and registries
  • Strong understanding of clinical trial design and real-world evidence methodologies
  • Demonstrated ability to develop and apply innovative analytical tools and approaches
  • Excellent communication and collaboration skills
  • Ability to work independently and cross-functionally in a fast-paced, matrixed environment

Why Parexel?

At Parexel, we put patients first. Our global team is united by a shared commitment to scientific excellence, operational integrity, and continuous learning. We foster a culture of inclusion, flexibility, and purpose-driven work—where your contributions directly impact the future of healthcare.


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