Application Support Expert
Based Reading, Berkshire or other European Locations
About the Opportunity
We have created new positions within our Global Business Support function to support GRA application for our Regulatory Affairs business objectives. As our Application Support Expert, you will represent users of the application to ensure the proper use of the functionality aligned with process. Be responsible for ITS interactions, B1 and B2 support structure for the GRA applications and Support the change control process with ITS and engage in UAT, Support and business activities.
· Support users with Training, administration and implementation of new functionality
· Leverage your system support knowledge to design, write and execute User acceptance scripts
· Provide accurate reporting of issues, problems and tasks and recommend trends
· Support the implementation of change controls. Consult with users and resolve end-user questions/problems and troubleshoot issues
· Provide input to the creation of quality documents, namely SOPs and WINs, user guides, job aids, etc
· Support coordinating activities for solution outage with appropriate user communities
· Track, govern and monitor Service Level Agreement breaches. Track, suggest, document and drive continuous improvement and simplification of system activities
· Be accountable to ensure that the User Acceptance test scripts are written and executed in a controlled state, following good validation methodology and documentation practices
Challenges Of The Job
· Dealing with diverse client personalities and managing expectations about timelines.
· Establishing working relationships with key business users. Issues resolved by working closely with client, keeping abreast of application changes and assessing their impact on the user community.
· Understanding user requirements and applying current technology to business problems
· Experience with the dynamic regulatory environment and systems to support it
· Ability to quickly analyze the impact of new system releases
· Connecting the application integration with end to end flow
· Helping users to adjust mindset with new systems
To excel in this role, you will need to have:
· Strong understanding of the different domains within Regulatory Affairs including Data Management, Labelling, Document Management and reporting needs
· Strong interpersonal and collaboration skills
· Experience Associated with validated systems/tools
· High degree of technical and Regulatory domain knowledge associated with systems/ tools
· Knowledge of Validation methodology, strategy, testing, documentation requirements and CFR Part 11 to support the validation of computer systems. Familiarity with Sanofi’s PUMA approach or similar model
· Process oriented with knowledge of Operational activities
· Demonstrated ability to multi-task and to work in a global team environment, customer focused and action oriented
· Ability to work with shifting priorities to meet project requirements; self-motivated
· Strong organizational, and communication skills
· Bachelor's degree in science, library or information management or equivalent experience
· Pharmaceutical industry experience
· Knowledge of Regulatory Operations domain, regulatory requirements and RIM systems
· Knowledge and experience working with Veeva VAULT RIM and Business Objects Universe design, creation, testing and technical skills are desired
· Knowledge of different domains within Regulatory Affairs including Dossier Creation and Submission Management, Labelling, Document Management and reporting needs
· Strong interpersonal skills to be effective in the leadership of or contribution to global teams
· Fluent with the English language
· Knowledge of other EU languages is very desirable
Empower Life Everyday
At Sanofi we work across human health from vaccines to rare diseases, and consumer healthcare. This creates opportunities to work across different areas to build a diverse and exciting career. Sanofi has the capabilities and resources to support your aspirations to fulfill your ambitions and be the best you can be.
Our purpose at Sanofi is to work passionately every day to understand and solve healthcare needs of people across the world. Our ambition is by 2025, to be a top 3 innovative, global and diversified human healthcare company. One that embraces transformative technologies and is focused on its area of excellence, which means we’re not there to try to solve everybody’s problems. We want to focus on those areas where we know we are making a difference.
The values we are live by are teamwork, courage, respect and integrity.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.