Director, Regulatory Data Management (Boston, MA)
$192,000–$288,000 year
HybridBoston, Massachusetts, United States
Job Summary
Lead the Regulatory Data Management function by setting vision, operating models, and performance expectations for regulatory data governance and quality. Manage and develop a team of professionals while overseeing RIMS data processes to ensure accurate collection, maintenance, and reporting of critical regulatory information. Establish data governance standards, drive inspection and audit readiness, and lead continuous improvement initiatives to strengthen data integrity and system adoption. Accountable for regulatory data quality, risk mitigation, and delivering metrics to senior management and governance forums.
Required Qualifications
- Experience in a leadership role in Regulatory information management/GxP data
- Bachelor's degree
- 10 years of experience in a technology area within a pharmaceutical/biotech company
- 3 years of supervisory/management experience
- Equivalent combination of education and experience
Desired Qualifications
- Highly developed Stakeholder Management skills
- Highly skilled in change management practices
- Demonstrated skills managing project timelines and organizing resources
- Strong attention to detail and the ability to manage complex, multiple projects
- Strong communication and influencing skills throughout all levels of the organization
- Ability to establish priorities and work with cross functional groups to deliver against strategic objectives
- Excellent analytical skills
- Experience managing personnel (internal FTEs or vendor management)
- Preference for life sciences or technology area
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