Overview
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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 xhfqzwm
- 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 (Medical & Scientific Writing) - Roche (Barcelona)
🏢 Jobrapido
📍 Barcelona