Job Title
In this pivotal role, you will play a crucial part in ensuring Regeneron's Data Governance systems and practices meet the highest standards of regulatory compliance.
Key Responsibilities:
* Assess current and evolving regulatory guidance to inform IOPS business practices.
* Serve as a Subject Matter Expert for authoring and developing standards, policies, and procedures aligned with regulatory requirements.
* Conduct technical writing, research, and editing activities to ensure accuracy and consistency in documentation.
* Generate data mapping processes and perform risk assessments on GMP documentation.
* Identify potential data governance gaps and propose solutions with implementation plans.
* Lead data integrity remediation activities and provide expertise during system development.
* Foster a culture of quality and Data Governance within the organization.
Requirements:
* Knowledge of applicable federal, state, and local regulations (e.g. GDPR).
* Technical writing experience and understanding of workflows and quality management terminology.
* Excellent collaboration and communication skills.
* Able to translate complex regulatory and technical requirements into clear guidance.
* Strong stakeholder management and influencing skills.
Education and Experience:
Bachelor's degree 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.
7+ years of professional experience or equivalent combination of education and experience.
Estimated Salary Range:
$120,000 - $180,000 per year.