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About Roche Informatics
In Roche Informatics, we build on Roche's 125-year history as one of the world's largest biotech companies, globally recognized for providing transformative innovative solutions across major disease areas. We combine human capabilities with cutting-edge technological innovations to do now what our patients need next. Our commitment to our patients' needs motivates us to deliver technology that evolves the practice of medicine.
Be part of our inclusive team at Roche Informatics, where we're driven by a shared passion for technological novelties and optimal IT solutions.
You are looking for a company where you have the opportunity to pursue your interests across functions and geographies.
About the position
As an Enterprise Design & Analysis Engineer, you will join the Enterprise Engineering cluster in the Product Development, Integration and Engineering chapter, you will partner with other internal experts, specializing in various aspects of Enterprise engineering. Together, the team collaborates on multiple products that contribute to Roche's internal business requirements.
As a Design & Analysis Engineer, you will be accountable for developing, optimizing, and managing IT services/applications in Veeva with focus on Regulatory submission management. You will also focus on ensuring cost-effectiveness, scalability, and security in all aspects of the digital product lifecycle, including maintenance activities. As part of enterprise engineering, you will be involved in understanding the business application processes and functions.
Your key responsibilities :
Collaborate with Product Managers to digitize the process of regulatory submissions and labeling on the Veeva RIM Vault and other applications across the Pharmaceutical regulatory submission process.
Lead, collaborate, and facilitate cross-functional experts to deliver a particular solution with a good understanding and documentation of the business requirements.
Requirements gathering, process mapping, and data analysis, will be important. Being able to elicit and document requirements effectively but also Hands-on configuring of the Veeva RIM Vault are your core capabilities and is key to success in this role.
Your qualifications and experience:
Understanding of Regulatory Operations: A solid understanding of Regulatory submission processes, regulations, and industry best practices is essential. Good understanding of the labeling submissions process is essential from a clinical and approved product label submission.
Business Analysis Techniques: Proficiency in business analysis techniques, such as requirements gathering, process mapping, and data analysis, will be important. Being able to elicit and document requirements effectively is key to success in this role.
Understanding of Veeva's architecture, data models
Proficiency in configuration tools and methodologies specific to Veeva
Profound knowledge and experience integrating Veeva with other applications.
Ability to develop build and test reports using built in tools within large platforms such as ServiceNow, ALM or Retina.
Certification of the Veeva platform will be value-added.
Excellent oral and written communication skills in English.
Working knowledge of Computer Systems Validation (CSV) and GxP.
Working knowledge of regulations like HIPAA and GDPR in the healthcare industry.
Moderate travel is required and the ability to work across multiple time zones.
Education / Years of Experience:
3-5 Years of relevant work experience with Bachelor’s degree in Computer Science/IT/Engineering or 5 – 7 Years of relevant work experience
At least 3+ years experience of working in one or more multinational work environments (e.g. life science industry experience is a plus).
Good analytical thinking and problem-solving skills
Good communication and collaboration skills
Good understanding of regulatory compliance and security
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.
Roche is an Equal Opportunity Employer.
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