Data Governance Specialist
Your role is fundamental in ensuring Regeneron's data is effectively managed and utilised whilst remaining compliant with regulatory requirements.
Key Responsibilities:
* Generate policies and procedures based on current and evolving global standards, ensuring global IOPS alignment and adjusting established policies and practices.
* Responsible with Site Leads for the creation and definition of KPIs.
* Accountable for senior leadership stakeholder engagement and holding the business to account in meeting the standards set.
* Accountable for Program Management and ensuring the DG (Policies & Programs) team is appropriately resourced, supported and has the tools and direction to properly execute their function.
* Establishing a successful relationship with Site Leads and their teams so a clear feedback loop is established.
* Supporting the preparation for regulatory inspections and audits related to DG by ensuring that policies, procedures, and documentation are up-to-date and compliant.
* Ambit 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.
This role may be for you if you have:
* Knowledge of applicable federal, state, and local regulations (e.g. GDPR).
* Demonstrable ability to oversee the creation of global policies, procedures and standards both with and through the business.
* Extensive experience demonstrating the ability to partner, influence and incorporate new standards.
To be considered for this role you must hold a BA/BS degree and 12+ years of professional experience or equivalent combination of education and experience in one of the following pharmaceutical/FDA regulated work areas: data management, quality assurance, compliance, manufacturing operations, technical operations, or IT.
Estimated Salary: $120,000 - $180,000 per year