Overview
In this role, you will drive clinical evidence generation and regulatory documentation for in vitro diagnostics within Roche's CDMA and CEI teams. You'll design clinical studies with SMEs, support regulatory submissions, and manage the document lifecycle to enable product registration and market access. You will collaborate跨-functional teams to translate scientific insights into robust clinical evidence. This position offers scope to influence IVD strategy, improve regulatory readiness, and mentor colleagues in a fast-paced, mission-driven environment.
Responsabilidades Design and support scientifically sound clinical studies for IVD products with SMEs
Generate and review protocols, reports, and regulatory documents
Analyze product portfolio for regulatory compliance and IVD-Regulation
Conduct literature reviews and synthesize clinical content with minimal guidance
Provide medical/scientific input for regulatory submissions and reviewer responses
Collaborate with Medical Affairs-Scientific Communications for ad-hoc writing




Oversee end-to-end document lifecycle and ensure timely delivery
Mentor less experienced CEI members and lead multiple projects
Foster continuous improvement and adherence to Roche procedures and quality systems
Maintain regulatory, clinical, and scientific expertise relevant to IVD product development
Requisitos principales Advanced degree in life sciences or related field
Solid scientific research and writing experience in clinical or regulatory documents
Experience with regulatory writing for IVDs or medical devices, including companion diagnostics (preferred)
Understanding of laboratory techniques (PCR, sequencing, serology, etc.) (preferred)
Understanding of basic statistical techniques (preferred)
Ability to travel up to 25%
collaboration
effective communication
mentoring
regulatory writing for IVD/medical devices
clinical study design and execution
literature reviews and content creation

📌 Clinical Development Lead (Barcelona)
🏢 Roche
📍 Barcelona