Medical Affairs Operations Leader

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Na Roche, você pode-se apresentar como você mesmo, abraçado pelas qualidades únicas que traz. Nossa cultura incentiva a expressão pessoal, o diálogo aberto e as conexões genuínas, onde você é valorizado e respeitado por quem você é, e permitindo que você prospere tanto pessoal como profissionalmente. É assim que pretend emos prevenir, deter e curar doenças e garantir que todos tenham acesso aos cuidados de saúde hoje e nas gerações futuras.

Junte-se à Roche, onde cada voz é importante.### A posiçãoDrive impactful real-world evidence  this role as a Medical Affairs Operations Leader, you will design and coordinate non-interventional studies, providing operational leadership across complex studies and cross-functional teams. Acting as a trusted partner within Medical Affairs, you will combine scientific expertise, operational excellence and collaboration to deliver high-quality evidence that supports informed medical and patient-focused decisions.###

The Opportunity
* You will operationally oversee Roche-managed and/or funded non-interventional studies, ensuring high-quality execution, global regulatory compliance, and inspection readiness throughout the study lifecycle.
* You will ensure regulatory, quality, and compliance oversight, maintaining alignment with GPP, GCP, applicable ISO standards (14155, 20916, 13485), EU-GVP, 21 CFR 812, EU-IVDR, and EU-MDR, including the completion of audit- and inspection-related corrective and preventive action plans.
* You will manage stakeholders and external partners, acting as the primary operational contact for Affiliates, CROs, vendors, and collaborative partners, monitoring performance, managing risks, and resolving issues.
* You will lead and support study teams, providing coaching, guidance, and training to ensure clear responsibilities, high performance, and a collaborative team culture.
* You will drive operational planning and feasibility activities, including study timelines, supply coordination, and risk management, to ensure efficient and effective study delivery.
* You will support budget, resource, and milestone management, including development, forecasting, tracking, and reporting of study and program budgets, operational metrics, and variances.
* You will oversee safety reporting, recruitment monitoring, and vendor oversight, ensuring timely reporting, effective CRO and service provider management, and support of audits and quality activities.
* You will optimize processes, documentation, and study close-out activities, maintaining study manuals and operational tools, and ensuring compliant site close-out, final drug accountability, final safety reconciliation, and Trial Master File inspection readiness.### Who you are
* You have relevant professional experience, with a minimum of 5 years in the pharmaceutical industry, a CRO, or an academic research setting, including hands-on experience in clinical or real-world evidence studies.
* You have expertise in evidence generation and scientific knowledge, with proven ability to set up, conduct, and close-out interventional and non-interventional studies, applying strong scientific principles to support meaningful study outcomes.
* You have strong project and operational management skills, capable of managing multiple studies or projects simultaneously, overseeing planning, timelines, budgets, and successful operational execution.
* You have a solid understanding of the requirements for drug and device development, ensuring compliance with clinical study regulations, standards, and processes to deliver high-quality results.
* You have experience in cross-functional and multicultural collaboration, building trusted partnerships and driving alignment across teams, geographies, and stakeholders.
* You have strong technical and analytical skills, including proficiency in data analysis, clinical research platforms, remote monitoring tools, and emerging technologies, with the ability to critically evaluate and apply insights effectively.
* You…