Data Governance Specialist
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.
You will be responsible for providing specialized knowledge and expertise in the design of data governance frameworks, policies, and procedures that are aligned with regulatory requirements and industry standards.
* Assessing current and evolving regulatory guidance and industry 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 appropriate approvals
* 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
Key responsibilities include:
* Leading data integrity remediation activities as per the DI Quality Plan
* Providing expertise and support during the development of new systems and processes
* Fostering a culture of quality & data governance within the organization and promoting the importance of data governance across all departments
* Driving communication and collaboration between stakeholders to ensure effective data governance practices
* Encouraging continuous improvement by actively seeking feedback and supporting initiatives designed to enhance data quality and governance
This role requires:
* 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 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
* Strong stakeholder management and influencing skills
* 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.
Salary: $120,000 - $180,000 per year (dependent on location and experience)
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 and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief, sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.