• Job Description

  Req#: 202303-106746

  The Position

  We are looking for you to join Roche and our Roche Services & Solutions Center in Budapest.

  Roche is a global healthcare company offering exceptional career paths and great benefits for fresh graduates and outstanding professionals. We are continuously expanding, looking for new talents to join our transforming Services & Solutions Center. We offer a flexible working framework (1 office day/week on average) and provide fully remote working conditions within Hungary .

  What we do:

  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.

  Your day to day responsibilities are:

  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.

  As a qualified expert, you:

  • 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

    • 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

    • 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.

  As an ideal team member, you are able to communicate clearly and professionally and work in a global team. Furthermore, you have:

  • 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.

  • 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 & trainings, 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, language allowance (if the position requires extra language), 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, and its conditions can be tailored for employees according to needs. 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/budapest-data-privacy-notice-candidate

  Who we are

  At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

  The Roche Services & Solutions as well as People Support Solutions organisations located in Budapest provide end-to-end business solutions for Finance, Procurement, IT, Communications, People & Culture (Human Resources) and beyond to our Roche colleagues across the EMEA region. Today Roche employs altogether around 1400 employees in Hungary.

  Roche is an Equal Opportunity Employer.

• About the company

  606018 F. Hoffmann-La Roche AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics.

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