Global Regulatory Affairs Data Steward

Job description

The mission of the Data Governance& 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, standards and controlled vocabularies with the primary goals of ensuring quality, compliance, and operational efficiency. The Governance Framework is clearly defines the purpose, objectives, teams, roles and responsibilities, and governance processes for the oversight of Regulatory data.
·  Promotes data literacy and understanding of our data, definitions and standards.
·  Supports business data models, data flows and data lineage mapping.
·  Provides oversight for the reporting and analytics activities.
·  Collaborates with the Business Process Excellence group to develop the reporting and analytics solution.
·  Collaborate with ITS colleagues to provide the reporting and analytics solution.

Supports internal audits and regulatory inspections by providing reports/extracts from the GRA Veeva Vault RIM solution

Duties and Responsibilities :

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 metadata standards in Sanofi's Regulatory Information Management (RIM) tool(s).

Responsibilities include:

·  Drives and coordinates resolution of Data Governance (DG) Requests to completion. Involves Coordinating with Data Owners, System Owners and Data Governance teams to support investigation and analysis of issues, and to conduct impact analysis of changes (to terms, standards, data formats), planning, preparation and implementation of changes to dictionaries (Controlled Vocabularies (CVs), picklists, controlled lists) in the Regulatory RIM tool(s).
·  Stays current with Regulations for data standards and controlled vocabularies.
·  Monitors regulatory agencies and industry standards organizations for status and versions of controlled vocabularies, to ensure Sanofi RIM terminologies stay current.
·  Supports Data Governance processes to ensure DG Requests are resolved and if approved, implemented,
·  Coordinates with multiple Data Owners who are physically located in countries around the world, and from many different Sanofi organizations and functions including Global Regulatory Affairs, Industrial Affairs, R&D Science, Clinical, Nonclinical and ITS.
·  Supports system integrations with the RIM, and coordinates with specific other system leads to ensure alignment and mapping between dictionaries across systems is maintained.
·  Supports investigation and resolution of integration errors related to data and dictionary mapping.
·  Supports Data Owners in query generation for the purpose of data quality oversight.
·  In collaboration with the Business Data Owners and Data Governance teams, define data structure and data business rules
·  Maintain associated pick lists (controlled vocabularies) within the new Vault RIM system.
·  Clearly documents DG recommendations and decisions for DG Requests, and maintains DG documentation. Maintains and prepares documentation of RIM dictionary content.
·  Supports development and maintenance of Job Aides describing detailed Data Steward activities.

Knowledge, Skills & Competencies :

· 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.

Qualifiications :

·  Minimum of a BS degree in science or engineering.
·  Strong knowledge of Regulatory Affairs/Operations domain and regulatory requirements related to data.
·  Ability to understand and communicate with representatives from the business (primarily Regulatory), and with ITS about issues related to data, data formats, and tool functionality.
·  Strong Veeva VAULT RIM 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.

Challenges of the job :

·  Workinng with diverse personalities from across the globe from various Sanofi organizations (some more business and others more technical oriented), to discuss and resolve data requests and issues.
·  Working under pressure with sometimes very tight timelines, and managing expectations about timelines and deliverables.
·  Establishing working relationships with key global business Data Owners. Issues resolved by working closely with client.
·  Keeping abreast of RIM data and dictionary related system changes and requests and assessing their impact on the user community.
·  Understanding DG Requests from users, and ability to investigate and present at Data Governance meetings to prepare Data Owners and to help racilitate resolution of DG Requests

Cultivating business relationships with vendor representatives and 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.