Job Title:
Data Governance Specialist
Job Summary:
In this role, you will play a pivotal part in ensuring that Regeneron's Data Governance systems and practices meet the highest standards of regulatory and industry compliance.
Key Responsibilities:
* Assessing current and evolving regulatory guidance and industrial intelligence in relation to IOPS business practices
* Subject Matter Expert (SME) for authoring and developing standards, policies and procedures in line with regulatory requirements and industry best practices
* Technical writing, research and related editing activities, ensuring accuracy and consistency of documentation and that the appropriate approvals are received
* Generating and performing data mapping processes, risk assessments of all GMP documentation and criticality assessments
* Identifying potential data governance and integrity gaps and proposing solutions with an implementation plan
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 an understanding of workflows and quality management technical writing terminology
* The ability to collaborate with other SMEs, DG Business Partners, ECM Specialists and cross-functional teams with excellent communication skills
* Ability to translate complex regulatory and technical requirements into clear guidance for cross-functional teams
* Strong stakeholder management and influencing skills
Education and Experience:
Bachelor's 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.
Salary:
$110,000 - $140,000 per year (dependent on location)
About Us:
We have an inclusive and diverse culture that provides comprehensive benefits, which often include health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.
Regeneron is an equal opportunity employer.