Your role is crucial in ensuring Regeneron's data is effectively managed and utilized while remaining compliant with regulatory requirements. This involves fostering a data compliance culture, developing comprehensive Data Governance (DG) policies and procedures, and staying up-to-date with industry trends, technology advancements, and external compliance decisions.
Key Responsibilities
* Developing policies and procedures based on current and evolving global standards to ensure global IOPS alignment.
* Collaborating with Site Leads to create and define Key Performance Indicators (KPIs).
* Engaging with senior leadership stakeholders to hold the business accountable for meeting set standards.
* Leading Program Management and ensuring the DG team is properly resourced, supported, and equipped to execute their function.
Additional Responsibilities
* Establishing successful relationships with Site Leads and their teams to facilitate a clear feedback loop.
* Supporting the preparation for regulatory inspections and audits by ensuring policies, procedures, and documentation are up-to-date and compliant.
* Evaluating and integrating Data Governance practices within the context of IOPS-related mergers, acquisitions, and partnerships.
* Fostering a culture of quality and Data Governance across all departments and promoting data accuracy, reliability, and transparency.
Requirements
* Knowledge of applicable federal, state, and local regulations, including GDPR, FDA Guidance on Data Integrity, EMA Data Integrity Guide, and WHO Guide to Data Integrity.
* Ability to oversee the creation of global policies, procedures, and standards with and through the business.
* Experience leading cross-functional teams and managing enterprise-wide data programs, operating, and influencing across a global organization.
Desirable Qualifications
* Leadership experience in a data integrity or Data Governance role.
* Bachelor's degree in a relevant field and 12+ years of professional experience or equivalent combination of education and experience.
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 and considers qualified applicants 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.