Global Regulatory Affairs Data Steward

Job description

The mission of the Data Governance, Reporting & Analytics Group i s to:

·  Be the business Regulatory group responsible for developing implementing and orchestrating a data governance framework for the oversight of Regulatory data, formats, standards and controlled vocabularies with the primary goals of ensuring quality, compliance, and operational efficiency. The Governance Framework clearly defines the purpose, objectives, teams, roles and responsibilities, and governance processes for the oversight of Regulatory data. Since data is critical both currently and even more so in the future, this group fills a critical role in Regulatory.Group provides key data related support for system integrations with Regulatory systems, including providing mapping of data and terminologies between systems and resolution of data related issues between systems. This includes systems between Regulatory and Vaccines, Industrial Affairs, Clinical and more, and includes support for product release. So this function and support is critical.
·  Governs the data business rules, objects and fields, formats, definitions, and dictionaries,picklists, controlled vocabularies used by GRA Systems.
·  Promotes data literacy and understanding of our data, definitions and standards with Data Owners, Regulatory Affairs, and other Sanofi organizations. .
·  Governs and supports business data models, data flows and data lineage mapping for Sanofi's Regulatory information Management (RIM) system. .
·  Provides oversight for GRA reporting and analytics activities. Develops strategy and vision for Reporting and Analytis function, and works towards achieving that target. Ensures function has robust processes to provide reports of high quality. Since Reports are submitted to Regulatory Authorities and are also used internally for management decisions, and other purposes and uses, the quality and timeliness of GRA Reports is critical.
·  Collaborates with the Business Process Excellence group to develop the solutions and capabilities needed to meet the current and emerging needs of Global Regulatory Affairs. This group supports Programs and projects within Regulatory and from outside of but related to Regulatory organization.
·  Group Collaborate globally with Organizational functions and team members across the globe, including Affiliates, Regions, Regulatory and other Sanofi Organizations outside of Regulatory including Industrial Affairs, R&D Science, Clinical, Nonclinical, Global Business Units, ITS and more.
·  Group Supports internal audits and regulatory inspections by providing reports/extracts from the GRA Veeva Vault RIM solution.

Regulatory Data Governance is working to ensure data dictionaries are harmonized across regions and compliant with regulations globally. The Data Steward supports Data Governance (DG) processes to ensure compliance, quality and oversight of data formats, definitions, and metadata standards in Sanofi's Regulatory Information Management (RIM) tool(s).

Responsibilities include:

·  Drives and coordinates resolution of Data Governance (DG) Requests to completion.
·  Work on Data Governance requests involves analyzing received requests and conducting impact analysis of requested changes. The Data Steward investigates the requests, including conducting research into related industry and regulatory standards and requirements related to data formats and controlled vocabularies. The Data Steward also Coordinate with Data Owners, System Owners, vendors, ITS, and Data Governance teams to investigate and analyze the request, impacts and related issues.
·  After conducting the investigation and impact analysis, the Data Steward presents all prepared information to the Data Owners, answers their questions, and provides recommendations to the Data Owners for resolution of the request.
·  The Data Steward also is responsible for either implementing the change directly, or coordinating with ITS or the vendor to ensure that the change is implemented as approved by Data Governance decisions.
·  Monitors regulatory agencies and industry standards for data related regulatory requirements, and changes and version status controlled vocabularies. Works to ensure Sanofi RIM data formats and terminologies stay current and compliant. Raises Data Governance requests when changes needed to support emerging Regulations and Industry standards related to RIM data and corresponding Controlled Vocabularies.
·  Enforces and Supports Data Governance processes, and works to ensure DG Requests are resolved and if approved, implemented correctly,
·  Works with multiple Data Owners who are physically located in countries around the world, and from many different Sanofi organizational functions including Global Regulatory Affairs, Global Regulatory Operations, Industrial Affairs, R&D Science, Clinical, Nonclinical, Quality, Pharmacovigilence, ITS and vendors.
·  Supports system integrations with the RIM, and works with system leads to ensure alignment and mapping between dictionaries across systems is maintained. Includes analysis and understsanding of dictionary terms, and interpretation of definitions to accurately map between systems. This has direct impact on data quality and information available to users.
·  Investigates data and metadata mapping related integration errors and issues and works on resolution. o.
·  Prepares data and dictionary related queries to support investigations and impact assessments and requests by Data Owners for the purpose of data quality oversight.
·  In collaboration with the Business Data Owners and Data Governance teams, defines and documents data model, data formats, and data related business rules
·  Maintains Regulatory Information Management (RIM) dictionaries in system.
·  Supports programs and projects, representing GRA Data Governance and Regulatory Information Management (RIM) data structures and definitions, processes, requirements and more.
·  Clearly documents DG recommendations and decisions for DG Requests, and maintains DG documentation. Maintains and prepares documentation of RIM dictionary content. This documentation used for traceability, audits, and for QC of the RIM database configuration.
·  Authors, maintains and reviews Data Governance Job Aides describing detailed Data Steward activities.

Knowledge, Skills & Competencies / Language

·  Experience with and understanding of Regulatory data, metadata a must. Must be able to understand Data Governance (DG) requests related to data, formats, and compliance requirements and must be able to communicate with Data Owners about requests and related issues.
·  Familiarity with EMAs (OMS/RMS), FDA data standards and other indicustry standards preferred
·  Experience in problem-solving techniques.
·  Candidates should be self-directed and proactive in identifying and evaluating data quality issues and to communicate these to the Data Governance Team.
·  Ability to drive activities to completion.
·  Keen verbal and written communication skills.
·  Candidate should be a team player, able to work collaboratively with the many roles supporting Data Governance and the RIM System. Ability to communicate clearly with team members who are from other geographic regions, and across Sanofi Organizations.
·  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.
·  Experience with Veeva Vault tool a plus but not required.

Qualifications

·  Minimum of a BS degree in science or engineering plus 6+ years of Industry and Regulatory data experience.
·  Strong knowledge of Regulatory Affairs/Operations domain and regulatory requirements related to data.
·  Demonstrated ability to understand complex data issues, and to communicate with representatives from various Sanofi business organizations (primarily Regulatory), and with vendors and ITS about technology requirements and issues related to data, data formats, and tool functionality.
·  Strong Veeva VaultRIM skills are desired.
·  Strong understanding of the different domains within Regulatory Affairs including Regulatory Tracking and Data Management, Labeling, Document Management and CMC/Quality. .
·  Working knowledge of regulatory requirements in multiple jurisdictions, specifically as they pertain to Registration Tracking.
·  Strong interpersonal skills to be effective in supporting and working with global teams.

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.

#GD-SA

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.