Internship in PD Medical Affairs Compliance and Process Excellence – Non-Interventional Studies; NIS) Optimization

Position: Internship in PD Medical Affairs Compliance and Process Excellence – Non-Interventional Studies (NIS) Optimization &

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.

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The Position Product Development Medical Affairs (PDMA) plays a pivotal role in advancing the future of healthcare by connecting scientific advances with medical practice needs and embedding medical practice realities into Roche strategies.

Join the PDMA Process and Compliance Excellence Team for a 12-month internship in Basel. This is your opportunity to gain hands‑on experience in strategic planning, business and project management, process optimization, systems, AI and digital tools, as well as resource and knowledge management.

About the Team

The PDMA Process and Compliance Excellence Team operates across molecules, indications, and the broader Roche organization to uphold business integrity and ensure regulatory, medical, and healthcare compliance for the benefit of patients and society. We engage across three key strategic pillars:
Patient‑Centric Activities Governance & Scientific Rigor Proactive Quality Management & Healthcare Compliance Technology & Digital Compliance Systems. We leverage our diverse expertise and strategic partnerships to drive proactive quality and compliance, adapt processes to evolving business needs, and harness modern technology to enhance operational efficiencies. Partnering seamlessly across Roche, we deliver high‑impact solutions, oversight, and advisory support that enable Medical Affairs to succeed with integrity.

The

Opportunity

This position focuses primarily on Non‑Interventional Studies (NIS) process optimization and harmonization, regulatory standards (GVP, GPP, MDR), cross‑divisional stakeholder engagement, and digital content migration and workspace redesign. As an intern in this role, you will lead and support high‑impact projects designed to streamline clinical study documentation and modernize digital compliance tools.

Your Responsibilities

• Template Harmonization:
  Develop unified, streamlined NIS protocol templates, Informed Consent Form (ICF) templates, and Clinical Study Report (CSR) templates applicable across non‑interventional study designs.
• Guidance Development:
  Consolidate standalone medical device wording and study design variations into a single, comprehensive companion guide providing clear instructions for different study types.
• Regulatory Alignment:
  Align template structures and companion guidance with relevant regulatory frameworks, including Good Pharmacovigilance Practices (GVP), Good Pharmacoepidemiology Practices (GPP), and Medical Device Regulations (MDR).
• Stakeholder Engagement:
  Engage cross‑divisional stakeholders to gather input, ensure alignment, and foster adoption of harmonized NIS documentation standards.
• Digital Workspace Redesign:
  Lead the migration, revision, and user‑centric redesign of the NIS gSite/intranet environment within Microsoft enterprise solutions.

Who You Are

• You are currently enrolled at a university (Bachelor's or Master's degree), or you have completed your studies within the 12 months prior to the internship start date, ideally in Life Sciences, Data Sciences, Business Administration, or a related field.
• You are a team player with strong communication, self‑reflection, and assertiveness skills.
• You are open‑minded, flexible, creative, and bring a proactive, can‑do attitude.
• You have project management and analytical skills, combined with a disciplined…