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 Clinical Trial Information System Team (part of Product Development Regulatory Operations) enables the development of organizational and people capabilities of the future, we support and optimize the delivery of projects and initiatives to the organization both on the molecule and molecule-enabling portfolio.

We are responsible for enabling the future of clinical trials from a regulatory perspective by pushing boundaries to deliver medical solutions now in order to transform patients’ lives.

Please note that this is a fixed term maternity cover position.

The Opportunity

As a CTIS-team Specialist, you will manage the administration of the EU CTA

CTIS User Management

Create initial CTAs as well as any other post-approval activities during the whole CTA lifecycle (e.g. modifications, inclusion of additional countries) in CTIS:

Support compilation & submission activities as per defined process and instructions from relevant functions for all CTA related submissions and manage & execute submission of all CTAs related activities via CTIS and inform relevant functions of submissions and related review timelines
 

Monitor CTIS for any incoming information from the HAs or ECs (e.g. questions) and interact with the different functions in order to address the information received.

Update, track and archive relevant information in internal systems

Drive overall process evolution:

Assessment of automation opportunities for CTIS management and management of CTA compilation and submission via CTIS and definition, rollout and testing of process improvements

What can you bring to our team:

We are looking for someone who has strong organizational and time-management skills; the ability to deliver under pressure; and the ability to work flexibly to support changing assignments and priorities in an independent and reliable manner.

Experience in a similar role or BA or BS (or equivalent) degree in biology, chemistry, pharmacy, or a related field

Previous experience with regulatory data, documents and dossier structures (e.g., CTD) or in the biotech or pharmaceutical industry is beneficial

Strong communication skills in English (written and spoken) are essential. Additional languages a plus, based on region/customer requirements

Sense of Urgency, clear Transparent Two-Way Communication and continuous improvement mindset

In exchange we provide you with:

Development opportunities: Roche is rich in learning resources. We provide constant development opportunities, free language courses & training, the possibility of international assignments, internal position changes and the chance to shape your own career. 

Excellent benefits & flexibility:  competitive salary and cafeteria package, annual bonus, Private Medical Services, Employee Assistance Program, All You Can Move Sportpass, coaching / mentoring opportunity, buddy program, team buildings, holiday party. We also ensure flexibility, to help you find your balance: home office is a common practice (2 office day/week on average).  We create the opportunity for freedom in working, where your corporate and private life coexist in harmony.

A global diverse community, where we learn from each other. At Roche, we cooperate, debate, make decisions, celebrate successes and have fun as a team. Our leadership is very focused on people, creating a strong, inclusive culture, so you always have the chance to share your opinion.

 Please read the Data Privacy Notice for further information about how we handle your personal data related to the recruitment process: https://go.roche.com/dpn4candidates 

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.