Regulatory Reporting and Data Analyst

Job description

Mission statements

The Global Regulatory Affairs (GRA) Reporting & Analytics team is the primary (GRA) group responsible for reporting and analytics activities for Regulatory. 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 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 support reports on Regulatory data needed for other areas of Sanofi.

GRA Reporting & Analytics group's mission is to:

·  Provide oversight for GRA reporting and analytics activities
·  Collaborate with the GRO Business Process Excellence group to develop the reporting and analytics solution
·  Collaborate with ITS colleagues to provide the reporting and analytics solution
·  Support internal audits and regulatory inspections by providing reports/extracts from the GRA RIM solution

Group's primary areas of responsibility include:

·  Function as the primary point of contact for GRA for reporting and analytics
·  Ensure that the reporting and analytic process is defined and implemented to meet the needs of the user community
·  Support the implementation of the targeted solution
·  Collaborate with ITS to provide the reporting and analytic solution,
·  Provide the requirement specification for development of the report
·  Participate in System Implementation Projects related to reporting and analytics

Duties & Responsibilities

The GRA Reporting & Analytics Specialist will be an integral member of the Reporting team. Responsibilities include:

·  Ensure that all report output and solutions meet the agreed user requirements and developed using the internal methodology. In addition, this group will build and publish standard reports for use by users on an as needed basis. The incumbent will be responsible to ensure validation documents support the intended use and are approved.
·  Support Inspections by Regulatory Authorities and Internal Audits by providing reports requested during inspectsion and audits. Requires ability to work under very tight timelines and high stress, and to deliver high quality report deliverables.
·  To provide operational support for the GRA Reporting process, including:
·  Review and analysis of user requirements for standard and ad hoc (custom) reports. .
·  Analysis of report requirements or specifications, against the data model, data configuration, data definitions and business rules for the data objects and fields to confirm they make sense technically and functionally for the business
·  Works with the users to refine requirements and specifications as needed to meet business needs and fit the data model, definitions, and configuration
·  Creates reports and/or updates existing reports to meet report requirements and specifications.
·  Provides quality control checks for both reports directly created and also for reports created by others. Documents and communicates clearly any issues found. If issues found relate to data issues, then notifies and works with GRA Data Management group to ensure data issues investigated and resolved.
·  Communicates with user about any data issues, provides report outputs.
·  Tracking of all report requests during workflow from start to finish.
·  Work with the Reporting Team Lead, GRA leadership and colleagues, GBUs, regions, affiliates, IA, GPE, GRO, Business Process Excellence group, and the ITS organization works to:
·  define the overall reporting and analytics strategy and framework. Note that the strategy and implementation of the solutions will be transversal nature and involve working with other functional areas to design the optimal solution and corresponding processes.
·  ensure that an analytic reporting process is defined, implemented and followed to meet the needs of the user community. Includes working with users to ensure process followed and understood.
·  understand completely the RIM data model, data definitions, and business rules for data to be able to support design reporting solutions, analyse report specifictions and requirements.
·  Support the implementation of targeted reporting and analytics solutions and related processes.
·  develop and implement new systems and tools necessary to support the GRA Reporting and analytics solution and framewor in a timely manner and compliant with company policy & regulations.
·  ensure that the 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.
·  define, develop and implement processes and ensure that the systems are in place to provide for appropriate Analytic reporting and, where necessary, for the identification and management of external vendors/consultants.
·  Provides operational oversight of the report solution environment, ensuring that environment for sharing reports is maintained and supports user community
·  Perform, verify and document the testing for the report systems. Ensure that Quality and Performance metrics are for testing are defined, tracked and reported
·  The incumbent will be nominated, as deemed appropriate, by the Reporting Team Lead, to various GRA projects team/committees. The incumbent will participate in the GRA projects as a stakeholder, and will ultimately assume responsibility to provide operational services.

This position requires a fair degree of technical knowledge and skills, understanding of databases,

·  data models, and reporting capabilities, development/testing/validation/performance enhancing strategies, Regulatory domain expertise, customer service with multiple interfaces with partners and customers within and outside of Sanofi (this includes all R&D, Affiliates, Industrial Affairs and commercial.
·  The incumbent will work closely with GRA leadership and colleagues, GBUs, regions, affiliates, IA, GPE, GRO, Business Process Excellence group, and the ITS organization to support the reporting and analytics solution.
·  The Reporting and Analytics requirements, process and data model design will be spearheaded by the Business Process and Operational Excellence group.
·  Works with projects teams and Interacts with end users to support gathering of reporting and anlaytics requirements and transcription of these to specific requirements for reports and analytics. Provide consise reporting and anlaytics requirements to the ITS organization for them to create capabilities and develop programs to provide reports, analytics and extracts
·  The ITS organization is responsible for the development and creation of the reporting and analytic technical solution
·  Responsibilities also include coordinating and working with contractors who provide additional reporting and analytic support.
·  The incumbent will be a member of the Data Governance and Analytics group with Centralized Operational Services, and as needed, will participate in the various projects that have reporting and analytics requirements.

Knowledge, Skills & Competencies / Language

·  Knowledge of Regulatory Affairs/Operations domain and regulatory requirements.
·  Business Objects Universe design, creation, testing and technical skills are preferred.
·  Understanding of the different domains within Regulatory Affairs including Data Management, Labeling, 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 detail.
·  Strong organizational, and communication skills
·  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.

Qualifications

·  Minimum of a BS degree in science or engineering.
·  Strong knowledge of Regulatory Affairs/Operations domain and regulatory requirements
·  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 desired.
·  Strong understanding of the different domains within Regulatory Affairs including Data Management, Labeling, Document Management and reporting needs.
·  Working knowledge of regulatory requirements in multiple jurisdictions, specifically as they pertain to Registration Tracking.
·  Ability to lead multi-disciplinary teams and interface with upper level management of support and client organizations.
·  Strong interpersonal skills to be effective in the leadership of global teams.
·  Language: English to work in an international context.

Knowledge and Skills desirable but not essential

·  2 year 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

·  Dealing with diverse client personalities and managing expectations about timelines. Establishing working relationships with key global business clients. Issues resolved by working closely with client.
·  Anticipation of requirements that will arise during regulatory inspections and audits.
·  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.

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.