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:
* Assess current and evolving regulatory guidance and industry intelligence in relation to business practices.
* Develop and author standards, policies, and procedures in line with regulatory requirements and industry best practices.
* Perform technical writing, research, and editing activities to ensure accuracy and consistency of documentation.
* Generate data mapping processes, risk assessments, and criticality assessments.
* Identify potential data governance and integrity gaps and propose solutions.
* Lead data integrity remediation activities as per the Quality Plan.
* Provide expertise and support during the development of new systems and processes.
* Foster a culture of quality and governance within the organisation.
About You:
* You have knowledge of applicable federal, state, and local regulations.
* You have technical writing experience and an understanding of workflows and quality management terminology.
* You can collaborate with cross-functional teams and communicate complex information effectively.
* You have stakeholder management and influencing skills.
* You have experience developing global policies and procedures.
Requirements:
* Bachelor's degree or equivalent combination of education and experience.
* 7+ years of professional experience in pharmaceutical/FDA regulated work areas.