Internship in PD Medical Affairs Compliance and Process Excellence – Non-Interventional Studies (NIS) Optimization & Digital Workspace (12 Months, Basel)

1201 F. Hoffmann-La Roche AG

Basel

Remote

CHF 22,000 - 33,000

Full time

4 days ago
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Job summary

Roche in Basel is offering a 12-month internship in the PDMA Process and Compliance Excellence Team. The role focuses on harmonizing NIS documentation, regulatory guidance, and digital tool migration to support compliant medical affairs processes.

You will collaborate across divisions, gain hands-on experience in project planning, and work with AI-enabled workflows while using Google Workspace and MS Office. English fluency is required.

Qualifications

  • Enrolled at university or recently graduated within 12 months, ideally in Life Sciences, Data Sciences, or related field.
  • Fluent in English, both spoken and written.
  • Strong communication and teamwork abilities are essential.
  • Familiarity with Google Workspace, Microsoft Office, and AI tools is expected.
  • Excellent organizational and documentation discipline.

Responsibilities

  • Template harmonization for NIS protocols, ICF, CSR across non‑interventional designs.
  • Develop companion guidance and consolidate regulatory wording.
  • Align templates with GVP, GPP, MDR requirements.
  • Engage cross‑divisional stakeholders to drive adoption.
  • Lead digital workspace redesign of NIS gSite within MS ecosystem.

Skills

Team player
Communication
Project management
Analytical skills
Self-motivation

Education

Bachelor's or Master's degree

Tools

Google Workspace
Microsoft Office
AI tools

Job description

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 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 approach to quality and documentation.
  • You have advanced knowledge of Google Workspace, Microsoft Office applications, and AI tools.
  • You are fluent in spoken and written English.
Additional information

Due to regulatory requirements, non‑EU/non‑EFTA citizens must provide a certificate from their university confirming that the internship is mandatory and specifying its required duration, as well as a certificate of enrollment. If you are proud to contribute and feel you have the dedication to teamwork and innovation that we are seeking, then Roche is the organization for you. Every role at Roche plays a part in making a difference in patients' lives.

Who we are

A healthier future drives us to innovate. Together, more than 100’000 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. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.

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