Regeneron Data Governance Specialist
In this pivotal role, you will ensure that Regeneron's Data Governance systems and practices meet the highest standards of regulatory and industry compliance. Your expertise in designing frameworks, policies, and procedures will align with regulatory requirements and industry standards.
Key Responsibilities:
1. Acknowledge current and evolving regulatory guidance and industrial intelligence related to IOPS business practices.
2. As a Subject Matter Expert (SME), author and develop standards, policies, and procedures according to regulatory requirements and industry best practices.
3. Conduct technical writing, research, and editing activities ensuring accuracy and consistency of documentation and obtaining necessary approvals.
4. Create data mapping processes and perform risk assessments of GMP documentation, as well as criticality assessments.
5. Identify potential data governance and integrity gaps and propose solutions with an implementation plan.
6. Lead data integrity remediation activities according to the DI Quality Plan.
7. Provide expertise and support during the development of new systems and processes.
8. Foster a culture of quality and DG within the organization and promote its importance across all departments.
9. Drive communication and collaboration between stakeholders to ensure effective DG practices.
10. Encourage continuous improvement by seeking feedback and supporting initiatives enhancing data quality and governance.
11. Lead/support initiatives embedding DG principles into the company's core values and everyday practices.
Requirements:
* Knowledge of applicable federal, state, and local regulations, such as GDPR, FDA Guidance on Data Integrity, EMA Data Integrity Guide, and WHO Guide to Data Integrity.
* Technical writing experience and understanding of workflows and quality management technical writing terminology.
* Ability to collaborate with SMEs, DG Business Partners, ECM Specialists, and cross-functional teams with excellent communication skills.
* Capacity to translate complex regulatory and technical requirements into clear guidance for cross-functional teams.
* Strong stakeholder management and influencing skills.
* Experience developing global policies, procedures, and standards both with and through the business.
Qualifications:
To be considered for this role, you must hold a BA/BS degree and 7+ years of professional experience or equivalent combination of education and experience in pharmaceutical/FDA regulated work areas such as data management & operations, quality assurance, compliance, manufacturing operations, quality control, or IT.