Data Governance Expertise
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This role requires a strong understanding of data governance principles and their application in regulated environments. A successful candidate will have knowledge of federal, state, and local regulations, as well as industry standards such as FDA Guidance on Data Integrity, EMA Data Integrity Guide, and WHO Guide to Data Integrity.
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Key Responsibilities:
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* Implementing and managing policies and standards within a regulated environment
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* Assessing business units' current policies and processes and overseeing the achievement of local data governance key performance indicators (KPIs)
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* Conducting regular data audits and assessments to identify data governance issues and work with business areas to prepare for data auditing and inspections
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* Fostering a culture of quality and data governance within the organization and promoting its importance across all departments
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* Driving communication and collaboration between stakeholders to ensure effective data governance practices
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Requirements:
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A bachelor's degree or equivalent experience is required. The ideal candidate will have 7+ years of professional experience in pharmaceutical/FDA regulated work areas, including data management & operations, quality assurance, compliance, manufacturing operations, quality control, or IT.
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Benefits:
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We offer an inclusive and diverse culture that provides comprehensive benefits, which may include health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.
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EQUAL OPPORTUNITIES EMPLOYER
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Regeneron is an equal opportunity employer and welcomes applicants from diverse backgrounds. We provide reasonable accommodation to qualified applicants with disabilities or chronic illnesses.
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