RWE Process & SOP Specialist

Our client, a leading biopharmaceutical organization, is looking for a specialist to ensure consistency and compliance across processes related to the conduct of RWE studies. The role focuses on managing SOPs, providing subject matter expertise, and supporting the implementation of high-quality research standards throughout the organization.

• Manage the periodic review and update of RWE SOPs, templates, and associated documentation to ensure compliance with international guidance.
• Act as a subject matter expert during the review of processes owned by other departments to ensure cross-functional consistency.
• Perform gap analyses on existing processes in response to new regulatory guidance or organizational changes to manage risks effectively.
• Develop and deliver training materials and process guidance for study teams conducting non-interventional research.
• Support audit preparation, study deviation processes, and the development of CAPA plans within the RWE domain.
• Maintain process trackers and contribute to new initiatives or system updates affecting study conduct.

• You possess a Master’s Degree in a relevant scientific or technical field.
• You have 8+ years of relevant experience, including 5+ years in a project management lead role for RWE or non-interventional studies.
• You bring a deep understanding of best practices related to the planning and execution of RWE studies, including primary collection and secondary data use.
• You have excellent organizational skills, strong attention to detail, and the ability to provide focused summaries from complex information.
• You are fluent in English.

Nice to Haves

• Previous experience in Quality Assurance or QA.
• Experience with successful cross-functional collaboration and negotiations.

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