Application Support Expert

Job description

Application Support Expert

Duties & Responsibilities

·  Represent users of the application to ensure the proper use of the functionality aligned with process
·  Responsible for ITS interactions, B1 and B2 support structure for the GRA applications
·  Support the change control process with ITS and engage in UAT, Support and business activities
·  Support users with Training and administration
·  Leverage 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
·  Accountable to ensure that the User Acceptance test scripts are written and executed in a controlled state, following good validation methodology and documentation practices

Knowledge, Skills & Competencies / Language

·  Strong understanding of the different domains within Regulatory Affairs including Data Management, Labeling, 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
·  Keen verbal and written communication skills
·  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
·  Ability to work under pressure to meet short deadlines
·  Preferred experience with ALM (Manual and Automated), Citrix, EDMS, Change management Systems, Veeva Vault,

Qualifications

·  Bachelor's degree in science, library or information management or equivalent experience. Minimum 4 year’s experience in the pharmaceutical industry
·  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, Labeling, 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

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

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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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.