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The Data Analyst is responsible for the investigation and analysis of complex Regulatory data issues and identifying root-causes of problems. This role usse methodologies and mechanisms for collecting and exploring structured, semi-structured, and unstructured data and relationships between data and corresponding tool functionality and processes. This position has a strong understanding of Regulatory data, its business use and Regulatory Information Management (RIM) system data models. The Data Analyst analyzes complex sets of data and their relationships, perceiving patterns and trends. This role utilizes Project Management (PM) skills and collaborates effectively with all users and stakeholders of Sanofi Regulatory data.
Understanding the data issue and defining the questions to be answered to resolve the data request. This requires working with users from across Sanofi to understand their questions and issues and related impacted business processes.
Exploring the data including the identifying the data in scope by translating the request by users in business terms to the data model. Also includes extracting the data sets ( groups of data and relationships) in scope.
Analyzing the extracted data by leveraging existing or developing new methodologies and techniques for looking for patterns and trends to determine the extent of the data problems. This includes conduct of root-cause analysis to discover the sources of the issue and impact analysis to understand the impact on the business.
Understanding and interpreting the results of analyses
Communicating the results and proposed solutions to users and stakeholders with various levels of knowledge about Regulatory data.
Collaborate with other functions and teams on identifying opportunities for business or technical improvements to avoid and/or resolve data errors.
Create documentation for recording steps of analysis followed, findings and results, and action items needed to resolve reported data issues.
Preparation and delivery of presentations for users and stakeholders to help them understand the issue, findings including root-cause, and next steps to resolve the problem.
Evaluate business processes, Job Aids and Training for impacts on data issues including identifying and collaborating on the need for updates, to avoid future data issues.
Propose, and test various methods for using tool functionality to correct data issues in most efficient manner. Test proposed solution (in tool sandbox environments).
Follow Project Management methodology to manage small data projects, to remediate data issues.
Develop and manage project charters, resource planning, and schedules, risk assessments. All efforts include tool functionality, testing, data remediation, and process changes as needed to address the specific data issue and to address preventing recurrence of the same issue.
Lead small projects from start to completion.
Lead small cross-functional project teams.
Collaborate with other organizational functions as necessary.
Track status, issues and risks, escalating issues when appropriate.
Prepare and deliver presentations on project and status as needed.
Finalize project documentation comprehensively.
Knowledge, Skills and Competencies:
Good Understanding of Regulatory data, data models, and systems.
Established ability to problem solve and analyze complex data issues. Demonstrated critical thinking with the ability to construct investigations to collect data aimed to support a pre-determined hypothesis.
Good Knowledge and understanding of regulatory affairs life cycle (i.e., research and development, variations, extensions, launches, pharmacovigilance, compliance, licensing).
Ability to collaborate transversally (across organizations and functions) in a fast paced, global and matrixed environment.
Proven ability to lead small projects are effectively driven to completion.
Demonstrated continuous improvement mindset.
a combination of people skills, regulatory business process and business data understanding, technical acumen, and project management skills.
Ability to communicate effectively, verbally and written, across varying functions and levels of management.
Solid presentation skills.
Ability to work under pressure, adaptability to change, solve problems and willingness to learn to drive to meet short deadlines and shifting prioritie.
Collaborative team player with orientation towards building and maintaining effective relationships, strong culture awareness.
Bachelor’s (University) degree in science, technology or information management.
5+ years’ experience in the bio/pharmaceutical industry with experience in Regulatory Affairs.
Good Knowledge of Regulatory Affairs/Operations domain, regulatory requirements and regulatory information systems.
Experience in data analysis, Regulatory data.
Experience with RIM tools (e.g., Veeva Vault RIM).
Prior Project Management experience preferred.
Challenges of the Job:
Understanding complex Regulatory data issues, relationships across the data model, relationship to system functionality and processes.
Understanding impacts on business and technology of data issue and proposed solutions.
Dealing with diverse personalities, varying levels of organizational structure and managing expectations with timelines with global colleagues in various functions (e.g,. Regulatory Affairs, Industrial Affairs, Procurement, Regions, Affiliates, ITS and Vendors).
Working and collaborating with people with very different levels of understanding of data and systems, including those with basic, minimal understanding.
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.
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.
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