Ensure Regeneron's Data Governance meets highest standards of regulatory and industry compliance by designing DG frameworks, policies and procedures aligned with regulations and industry standards.
About the Role
* Assess current and evolving regulatory guidance and industrial intelligence in relation to IOPS business practices.
* Author and develop standards, policies and procedures in line with regulatory requirements and industry best practices as Subject Matter Expert.
* Perform technical writing, research and editing activities ensuring accuracy and consistency of documentation and approvals are received.
* Generate data mapping processes, risk assessments of GMP documentation and criticality assessments.
* Identify potential data governance and integrity gaps and propose solutions with implementation plans.
* Lead data integrity remediation activities as per the DI Quality Plan.
* Provide expertise and support during development of new systems and processes.
* Foster a culture of quality & DG within the organisation and promote importance of DG across all departments.
* Drive communication and collaboration between stakeholders to ensure effective DG practices.
* Encourage continuous improvement by actively seeking feedback and supporting initiatives to enhance data quality and governance.
* Lead/support initiatives to embed DG principles into company's core values and everyday practices.
About You
* Hold 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.
* Have technical writing experience and understanding of workflows and quality management technical writing terminology.
* Possess ability to collaborate with other SMEs, DG Business Partners, ECM Specialists and cross-functional teams with excellent communication skills.
* Be able to translate complex regulatory and technical requirements into clear guidance for cross-functional teams.
* Have strong stakeholder management and influencing skills.
* Experience developing global policies, procedures and standards both with and through the business.
Requirements
* Bachelor's or Master's degree in relevant field.
* 7+ years professional experience in pharmaceutical/FDA regulated work areas such as: data management & operations, quality assurance, compliance, manufacturing operations, quality control, or IT.