In this role 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 specialised knowledge and expertise in the design of (DG) frameworks, policies and procedures that are aligned with regulatory requirements and industry standards.
In this role, a typical day might include the following:
1. Assessing current and evolving regulatory guidance and industrial intelligence in relation to IOPS business practices.
2. Subject Matter Expert (SME) for authoring and developing the standards, policies and procedures in line with regulatory requirements and industry best practices.
3. Technical writing, research and related editing activities, ensuring accuracy and consistency of documentation and that the appropriate approvals are received.
4. Generating and performing data mapping processes, risk assessments of all GMP documentation and criticality assessments.
5. Identifying potential data governance and integrity gaps and proposing solutions with an implementation plan.
6. Leading data integrity (DI) remediation activities as per the DI Quality Plan.
7. Providing expertise and support during the development of new systems and processes.
8. Fostering a culture of quality & DG within the organisation and promoting the importance of DG across all departments.
9. Driving communication and collaboration between stakeholders to ensure effective DG practices.
10. Encouraging continuous improvement by actively seeking feedback and supporting initiatives designed to enhance data quality and governance.
11. Leading/supporting initiatives to embed DG principles into the company’s core values and everyday practices.
This role may be for you if you have:
1. 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.
2. Technical writing experience and an understanding of workflows and quality management technical writing terminology.
3. The ability to collaborate with other SMEs, DG Business Partners, ECM Specialists and cross-functional teams with excellent communication skills.
4. Ability to translate complex regulatory and technical requirements into clear guidance for cross-functional teams.
5. Strong stakeholder management and influencing skills.
6. Experience of developing global policies, procedures and standards both with and through the business.
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.
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