Job Summary
In this role, you will be responsible for implementing data governance standards, policies, and procedures into business operations.
Main Responsibilities:
* Implement standards, policies, and procedures within allocated areas of the business.
* Support and advise allocated business area(s) on good data governance practices and engage with allocated business unit on DG priorities and action plans.
* Assess allocated business unit's current policies and processes and oversee the achievement of local data governance KPIs.
* Conduct regular data audits and assessments to identify data governance issues and work with business area to prepare for DG auditing and inspections.
* Work in partnership with other DG Business Partners, Technical DG Experts & ECM Experts to deliver on the DG plan and feedback themes to allow continuous improvement and evolution of the DG approach.
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.
* Demonstrated success in implementing and managing policies and standards within a regulated environment.
* Excellent communication and collaboration skills.
* Strong stakeholder management and influencing skills.
* Experience in use of quality systems and/or change management.
Education and Experience:
* Bachelor's degree required; 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.
About Regeneron:
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 (or lack thereof), 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.