CTIS (Clinical Trial Information System) Team Specialist
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Job Summary
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
The Opportunity
As a CTIS-team Specialist you will manage the administration of the EU CTA submission portal coordinate and support the compilation completion and submission of EU Clinical Trial Applications (CTAs) and CTA related information monitor and handle incoming information from regulators and ethics committees with other functions.
This is a one year Fixed term position were you will be focusing on:
Creating initial CTAs and handling post-approval activities throughout the CTA lifecycle including modifications and adding new countries in CTIS.
Supporting compilation and submission of CTA-related documents following defined processes and guidance from relevant functions.
Managing and executing submission of CTA-related activities in CTIS and communicating timelines to relevant teams.
Monitoring CTIS for updates or inquiries from Health Authorities (HAs) or Ethics Committees (ECs) coordinating responses with the relevant functions.
Tracking and archiving Health Authority inquiries and sponsor responses in internal systems like Veeva Regulatory Information Management.
Ensuring accuracy and maintaining high-quality records of correspondence while adhering to internal protocols and regulations.
Assessing automation opportunities define test and roll out process improvements for CTIS management and CTA submission workflows.
Who you are:
Experience in a similar role or minimum 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. CTI 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
Ability to communicate clearly and professionally
Proficiency in a broad range of IT skills
Data and document management skills
Attention to detail especially with respect to data
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: Roche Annual Bonus Monthly transportation allowance Home Office set - up equipment Health Insurance Life/Accident insurance Full salary when on sick leave for the first 9 days Eyeglasses settlement One-time payment options for various events in the life e.g. wedding childbirth Service Awards: We value loyalty with additional holidays and bonus payment Work in a hybrid model (2 days/week from the office)
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.
Salary starts from 2400 EUR gross/monthly. Final salary depends on the successful candidates level of experience skills and qualifications.
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.
Required Experience:
IC
Key Skills
- Computer Science
- Active Directory
- Clearance
- Facility
- HVAC
- Linux
- Project Management
- Troubleshoot
- Desktop
- Control Systems
- Management System
- Setup
- hardware
- Data Analysis
- Technical Support
About Company
F. Hoffmann-La Roche AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange. The company headquarters are located in Basel.
