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. GRA Reports and reporting solutions are critical to support inspections by Regulatory Authorities, and audits, Regulatory decisions and activities, information provided to Health Authorities, and for compliance with global regulatory requirements, to help the responsible group verify Key Performance Indicators (KPI), for the user community to self-check their compliance with KPIs. GRA provides services globally to all R&D units and to all Sanofi affiliates (fully connected sites plus all countries with industrial and/or commercial operations). The Reports team primarily supports GRA but can also provide reports and analytics on Regulatory data needed for other areas of Sanofi.
GRA Reporting & Analytics group’s missions are to:
Provides vision and strategy for the GRA reporting and analytics framework.
Be the primary point of contact for GRA Reporting and Analytics information needs.
Collaborates with the GRA Data Management and Data QC functions to ensure information provided is of highest quality.
Collaborates with the GRO Business Process Excellence, ITS and other functions to develop the GRA Reporting and Analytics technical solutions that are aligned with the vision and strategy.
Analyse requirements and specifications for information, reports and analytics with a solid understanding of Regulatory business data, system data models, and technical skills.
Ensures that report and analytics designs providing the quality information needed by Regulatory for decision making, health and safety reporting, and other organizational activities.
Prepares information, reports, extracts and analytics for Regulatory Organization and Leadership, and for internal audits and inspections by Regulatory Agencies.
Group’s primary areas of responsibility include:
Functions as the primary owner and point of contact for GRA for reporting and analytics capabilities and activities.
Ensures that the formal reporting and analytic process and methodology is defined, implemented and followed to ensure quality deliverables and to meet the needs of the user community.
Provides the vision and strategy for Reporting and Analytics.
Leads the development of GRA business requirements for Reporting and Analytics target solutions.
Collaborates with ITS to provide the reporting and analytic solutions.
Leads or supports Reporting and Analytics related projects for Systems Implementation Projects.
Ensures highest quality information provided to customers in an efficient way.
Duties & Responsibilities
The Regulatory Reporting & Data Analyst is an integral member of GRA and the Reporting & Analytics team. Responsibilities include:
Be the primary point of contact for EU inspections & audits. Corporates with US colleagues for US inspections & audits if the requests need to be done at EU time zone.
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 that the information provided, and report designs are of high quality and align with information needs.
Receives each request, reads it, understands it.
Reviews with business user to ensure report requirements are complete. Works with user to update report requirements as needed.
Using finalized report requirements, analyses data model to assess data objects and fields needed, and complexity of relationships between data objects.
Updates report requirements / specifications based on data model analysis.
Using technical programming skills, creates reports and/or updates existing reports to meet requirements and specifications.
Plans design for program code.
Programs / codes the report or analytic request.
Runs the report program and checks the output.
Updates the program code as needed to fix any issues.
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 quality control checks for reports and analytics including those created directly and those created by other Report Analysts and our outsourced vendors. Documents findings, communicates issues clearly and works with information creators to correct issues. When issues found are not report related but derive from source data issues, then works with the GRA Data Management and Data QC groups to ensure data issues investigated and resolved. Ensures that Quality and Performance metrics are for testing are defined, tracked and reported.
Provide QC checks and oversight for reports programmed by other codes: first by reviewing the original report requirements. Then compare these requirements against the report or analytic output generated.
Document findings on QC checklist. Clearly identify if issue is a source data issue or a report coding issue.
Coordinate / communicate with program coder, explaining review findings and explaining issues.
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.
Confirm report or data analysis is complete and any QC issues have been resolved.
Contacts user who requested the report or data analyst and provides requested output. Confirms that report meets requirements as expected. Reviews deliverable with user to discuss any additional changes if needed to address any user concerns.
If any concerns, then updates report requirements and provides updates to programmer to make needed updates. If no issues, then tracks resolution.
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. Represents Reporting & Analytics business needs, requirements and processes on projects and programs developing technical solutions and systems. Supports the implementation of targeted reporting and analytics solutions and related processes. Works collaboratively with project teams to develop and implement new systems and tools necessary to support the GRA Reporting and analytics solution and framework in a timely manner and compliant with company policy & regulations.
Participates in project meetings related to new systems for Regulatory and representing reporting team and needs.
Develops requirements for reporting and data analytical functionality. Includes working with business users on business needs for reports.
Supports development of reports in new system, using requested functionality, and testing system report capabilities.
Cooperates with offshore teams and vendors in an efficient way to provide GRA Reporting and Analytic deliverables for GRA, inspections and audits. Explains information requirements and specifications to contractors and vendors, answers their questions, provides timelines for deliverables and monitors status and progress, and provides general oversight for work towards GRA Reporting and Analytics deliverables.
When inspections and audits planned, works with inspection teams to prepare for inspection or audit. Includes reviewing any pre-requested reports for the Regulatory Agency conducting the inspection or internal audit team.
Prepares requested reports or presentations to support the inspection or audit.
Responds to questions or additional requests during the inspection or audit.
Ensures that the systems capabilities are in place for Reporting & Analytics needs.
Ensures that the Reporting & Analytic tools are operating in a controlled state with validated systems/tools to comply with industry standards and FDA/EU Authority requirements, as well as other authorities globally.
When new systems put in place ensure all validation documents related to reporting, reports and report specifications are complete and filed in a controlled manager.
Review validation documentation related to reporting for systems, reports and/or specifications whenever changes made, and on regular basis to ensure up to date and on hand for inspections and audits.
Provides Operational oversight of the report solution environment, ensuring that environment for sharing reports is maintained and supports user community.
Regularly tests tool functionality related to reporting, to ensure working correctly and appropriately according to system specifications.
Reviews report requests provided by users and checks against deliverables provided by programmers / coders to ensure all working and in control.
Meets with business representatives regularly to ensure reporting and analytic deliverables meet expectations and are of high quality. Works to plan for future capabilities needed to support new and emerging regulatory compliance requirements.
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.
Participates in meetings to review and update the data models for Regulatory systems.
Supports Regulatory Organizational needs, including compliance training, performance reviews, and other.
Knowledge, Skills & Competencies / Language
Knowledge of Regulatory Affairs/Operations domain and regulatory requirements.
Completely understands the Regulatory business data, Regulatory Information Management (RIM) and other GRA system data models, data definitions, and business rules for data. This is needed to be able to support quality design reporting solutions, analyse report requirements and specifications. And to be able to represent Reporting and Analytics for GRA in systems projects.
Business Objects Universe design, creation, testing and technical skills are preferred.
Technical knowledge and skills, understanding of databases, data models, and reporting capabilities, development/testing/validation/performance enhancing strategies and Regulatory domain expertise.
Understanding of the different domains within Regulatory Affairs including Data Management, Labelling, Document Management and reporting needs.
Ability to participate in multi-disciplinary teams and interface with upper level management of support and client organizations.
Strong interpersonal skills to be effective in global teams.
Experience in problem-solving techniques.
Keen verbal and written communication skills. Ability to clearly document report specifications.
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.
Excellent attention to details.
Strong organizational and communication skills.
Focus on high quality report deliverables.
Ability to work under pressure to meet short deadlines.
Knows when sufficient data has been collected to solve a problem.
The ability to understand the great importance of database accuracy.
Experience with customer service with multiple interfaces with partners and customers within and outside of Sanofi (this includes all R&D, Affiliates, Industrial Affairs and commercial).
Minimum of a BS degree in math, science or engineering with 5+ years’ experience in pharmaceutical industry is preferred.
Strong knowledge of Regulatory Affairs/Operations domain and regulatory requirements.
Strong knowledge of SQL or SAS, Python.
Strong 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.
Strong Veeva VAULT RIM and Business Objects Universe design, creation, testing and technical skills are preferred.
Strong understanding of the different domains within Regulatory Affairs including Data Management, Labelling, Document Management and reporting needs.
Strong interpersonal skills to be effective in the leadership of global teams.
Language: English to work in an international context.
Ability to travel at minimum level.
Knowledge and Skills desirable but not essential
5 years’ experience in ITS technical support.
ITS skills: technical and database background.
Experience on Regulatory systems”; “end-user support”.
Basic knowledge of GxP, Good Pharmacovigilance Practices.
Challenges of the job
Complex need for solid understanding of Regulatory business data, systems, data models, data definitions, and reporting and analytics.
Ability to interpret user requirements and specifications and translate to data model, definitions, systems, Regulatory business requirements and more.
Need to cooperate transversally with diverse users and colleagues, managing expectations and timelines. Establish working relationships with key global business clients. Resolve Issue by collaborating closely with colleagues and users.
Anticipation of requirements that will arise during regulatory inspections and audits. Ability to work under high stress situations, with tight timelines, providing high quality deliverables of critical importance to Sanofi and the Regulatory organization.
Keeping abreast of GRA systems changes and assessing their impact on the user community.
Understanding user requirements and applying current technology to business problems. Cultivating business relationships with ITS colleagues.
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