Medical Affairs Operations Leader

At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.

The Position

Drive impactful real-world evidence generation.

In 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 ( 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 have excellent communication influence and stakeholder management abilities with the skill to negotiate and engage stakeholders at all levels while maintaining a customer- and quality-focused mindset.

Locations : Basel Welwyn

Travel Flexibility : Willingness to travel as needed to attend study-related meetings (5-10%)

Are you interested in making an impact Please apply by submitting your updated CV via our careers portal.

Where pay transparency applies details are provided based on the primary posting location. For this role the primary location is Basel. If you are interested in additional locations where the role may be available we will provide the relevant compensation details later in the hiring process.

Who we are

A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.

Key Skills

Problem Management,ISO 9001,Process Improvement,Warehouse Experience,Business Management,Project Leadership,IT Service Management,Project Management,Strategic Planning,DoD Experience,Clamp Truck,Leadership Experience

Employment Type : Full-Time

Experience : years

Vacancy : 1