Senior Business Analyst, R&D Informatics (all genders) - full-time/part-time

Your role:

Being part of "DDIT R&D", the "Veeva Vault Solutions Team" is responsible for currently four business applications running on the platform "Vault" provided by the vendor "Veeva". Our team of ca. 27 colleagues, coming both from R&D IT and R&D business and based in Darmstadt and Bangalore, takes care for the smooth operations and further development of the applications, runs associated projects and provides business and technical support to the worldwide end user community coming from almost all R&D business functions in Healthcare and beyond.

As the Lead Expert in Quality, you will play a pivotal role in our team as a "translator" between business needs and IT capabilities. Your primary responsibility will be to assess/ analyse Business requirements coming from the R&D user community as well as functionalities regularly offered by Veeva as releases for the Quality Vault system and align with regards to the system configuration. You will ensure that the system configuration meets the evolving needs of our stakeholders while adhering to industry best practices.

Key Responsibilities:

• Requirements Analysis: Collaborate with R&D teams to gather and document business requirements, ensuring a clear understanding of their needs and expectations.
• System Configuration: Analyze Veeva Vault Quality functionalities and align them with business requirements, facilitating optimal system configuration.
• Process Documentation: Create detailed process maps and documentation to support system configuration and user training.
• Knowledge Transfer: Develop and maintain internal training materials and knowledge transfer documents to empower teams in effectively utilizing the Veeva Vault Quality system.
• Collaboration: Work closely with the Technical Support Team, System and Process Leads, and the Change Board to ensure seamless integration of new functionalities and processes.
• Continuous Improvement: Participate in regular reviews of system performance and user feedback to identify areas for improvement and implement necessary changes.

Who you are:

• Higher degree in a scientific discipline or related work experience

• At least 5 years of professional experience in a pharmaceutical company or service provider, thereof at least 3 years in Regulatory Affairs

• Extensive practical hands-on experience in regulatory quality management (tools) incl. data governance

• Veeva White Belt Certification (nice to have)

• Demonstrated experience in managing system administration support (1st and 2nd level) in a regulated environment (incl. computer systems validation)

• Demonstrated experience in managing business-relatedtechnologyanddata transferprojects

• Excellent Microsoft Office know how (in part. MS Excel)

• Strong organizational and planning skills and independent working

• Strong analytical problem-solving skills incl. quick comprehension

• Strong stakeholder management skills

• Strong communication skills, incl. demonstrated experience in customer communication and presentation

• Strong customer orientation and service mentality

• Meticulous working style and quality awareness

• Demonstrated experience of working in intercontinental teams, collaborative mindset

• Assertive, proactive, flexible, speak up personality

• Excellent written and spoken communication skills in English (knowledge of German is an asset)

Department: HC-HF-IRVC Cross Vault
Job evaluation: AT-level 3 (Expert)