SANOFI
The Global Regulatory Affairs (GRA) Reporting & Analytics team is the primary (GRA) group responsible for reporting and analytics activities for Global Regulatory Affairs. This group works to ensure that GRA has access to state-of-the-art reporting solutions and supports providing reports and analysis needs for the department, including inspections, audits and general business needs.
About Growing with us
Main responsibilities
Using Regulatory business data knowledge, understanding of system data model(s) and technical skills, analysis requirements and specifications for Regulatory information, reports, and analytics. Analyse against system data configuration and models, data definitions, and business rules for the data objects and fields to confirm they are appropriate technically and functionally for the specific business needs. Works with requesters to refine requirements and specifications to ensure the information provided, and report designs are of high quality and align with information needs
Work with customer directly to translate regulatory business language to technique language and use technical programming skills, creates reports and/or updates existing reports to meet
Be the primary point of contact for EU inspections & audits, participate in preparation and planning for inspections and audits. Corporates with US colleagues for US inspections & audits if the requests need to be done at EU time zone
Using formal quality methodology, business and technical knowledge, ensures the quality of information deliverables provided in reports and analytics meet the agreed user requirements and specifications and are of high quality
Provides report and analytic deliverables to and communicates with requestors to ensure requests have been satisfactorily met. Works with users to resolve any concerns about deliverables. Tracks and logs status of each request, clearly documenting progress of request, and all corresponding needed KPIs and metrics
Collaborates with the GRA Reports & Analytics Lead, GRA leadership and colleagues, GBUs, regions, affiliates, IA, GPE, GRO, Business Process Excellence group, and the ITS organization on Reporting and Analytics Capabilities in GRA Systems
Contributes as a member of the GRA Data Governance, Reporting & Analytics group within Centralized Operational Services, and as needed, participate in the various projects that have reporting and analytics requirements
About you
Experience:
Understands the Regulatory business data, Regulatory Information Management (RIM) and other GRA system data models, data definitions, and business rules for data
Experience in data analysis and problem-solving techniques
Pharmaceutical industry experience using PowerBI or SQL is required
Soft skills:
Ability to multi-task and participate in multi-disciplinary teams and interface with upper-level management of support and client organizations
Interpersonal skills to be effective in global teams both written and verbally
Ability to work with shifting priorities to meet project requirement and self-motivated
Excellent attention to details with strong organizational and communication skills
Ability to work under pressure to meet short deadlines and travel at minimum level
Technical skills:
Ability to clearly document report specifications and focus on high quality report deliverables
Average to above average level of knowledge of SQL and Power BI
Knowledge of Microsoft Excel, VBA is a plus
High degree of technical knowledge, reporting capability development, testing, validation, query and report performance enhancing strategies are strongly desired
Veeva VAULT RIM and Business Objects Universe design, creation, testing and technical skills are preferred
Education:
Bachelor’s degree, or equivalent, in Math’s, Science, or Engineering
Languages
Excellent written and verbal communication skills in English
