Overview¿Es este el puesto que está buscando? Si es así, siga leyendo para obtener más detalles y no olvide enviar su solicitud hoy mismo.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.ResponsabilidadesDesign and support scientifically sound clinical studies for IVD products with SMEsGenerate and review protocols, reports,



and regulatory documentsAnalyze product portfolio for regulatory compliance and IVD-RegulationConduct literature reviews and synthesize clinical content with minimal guidanceProvide medical/scientific input for regulatory submissions and reviewer responsesCollaborate with Medical Affairs-Scientific Communications for ad-hoc writingOversee end-to-end document lifecycle and ensure timely deliveryMentor less experienced CEI members and lead multiple projectsFoster continuous improvement and adherence to Roche procedures and quality systemsMaintain regulatory, clinical, and scientific expertise relevant to IVD product developmentRequisitos principalesAdvanced degree in life sciences or related fieldSolid 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%collaborationeffective communicationmentoringregulatory writing for IVD/medical devicesclinical study design and executionliterature reviews and content creation

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