Job Title:
Data Governance Specialist
About the Role:
In this critical position, you will play a pivotal part in ensuring that Regeneron's Data Governance (DG) systems and practices meet the highest standards of regulatory and industry compliance.
You will be responsible for providing specialized knowledge and expertise in the design of (DG) frameworks, policies, and procedures that are aligned with regulatory requirements and industry standards.
Daily Responsibilities:
1. Assess current and evolving regulatory guidance and industrial intelligence in relation to IOPS business practices.
2. Author and develop standards, policies, and procedures in line with regulatory requirements and industry best practices as Subject Matter Expert (SME).
3. Perform technical writing, research, and related editing activities, ensuring accuracy and consistency of documentation and appropriate approvals.
4. Generate and perform data mapping processes, risk assessments of all GMP documentation, and criticality assessments.
5. Identify potential data governance and integrity gaps and propose solutions with an implementation plan.
6. Lead data integrity (DI) remediation activities as per the DI Quality Plan.
7. Provide expertise and support during the development of new systems and processes.
8. Foster a culture of quality & DG within the organization and promote the importance of DG across all departments.
9. Drive communication and collaboration between stakeholders to ensure effective DG practices.
10. Encourage continuous improvement by actively seeking feedback and supporting initiatives designed to enhance data quality and governance.
11. Lead/support initiatives to embed DG principles into the company's core values and everyday practices.
Requirements:
* Knowledge of applicable federal, state, and local regulations (e.g. GDPR), rules, policies, and procedures such as 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 other SMEs, DG Business Partners, ECM Specialists, and cross-functional teams with excellent communication skills.
* Able to translate complex regulatory and technical requirements into clear guidance for cross-functional teams.
* Strong stakeholder management and influencing skills.
* Experience of 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.
Estimated Salary:
$140,000 - $170,000 per year based on location and experience.