Vertex Pharmaceuticals

Vertex Pharmaceuticals

Director, Regulatory Data Management (Boston, MA)

Boston, MA · Director

Sponsorship not specified$192k-$288kDetected 12 days ago
Stakeholder ManagementVendor ManagementRecruitingLeadershipCommunicationGxP

About the role

  • This role provides leadership for the accurate collection, maintenance, quality oversight, reporting, and inspection readiness of critical regulatory data and documentation.
  • Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
  • Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1.

Responsibilities

  • Manage, coach, and develop a team of regulatory data professionals, including setting objectives, managing workload and priorities, supporting career development, and ensuring effective execution of team deliverables.
  • Establish and maintain data governance standards, including ownership models, data definitions, quality expectations, process documentation, and accountability frameworks for regulatory data stewardship.
  • Drive inspection and audit readiness for regulatory information maintained in RIMs, ensuring data, documentation, processes, and evidence are complete, accurate, traceable, and readily retrievable; the source role includes responsibility for inspection readiness and liaison support for inspections and audits.
  • Lead development and delivery of regulatory data reporting and metrics for senior management, governance forums, program teams, and other stakeholders, expanding the source role's accountability for informational reports and metrics.
  • Lead continuous improvement initiatives to strengthen regulatory data integrity, reduce process variation, improve system adoption, and enhance the usability of regulatory information for decision-making.
  • Ensure effective onboarding, training, and capability building for team members and stakeholders who contribute to or rely on regulatory data
  • The Director leads and develops a team responsible for regulatory data stewardship, establishes scalable processes and standards, and partners cross-functionally to ensure regulatory information is complete, reliable, inspection-ready, and positioned to support portfolio, operational, and compliance decision-making.

Skills

  • Experience in a leadership role in Regulatory information management/GxP data
  • Highly developed Stakeholder Management skills
  • Highly skilled in change management practices
  • Demonstrated skills managing project timelines and organizing resources
  • Strong communication and influencing skills throughout all levels of the organization
  • Excellent analytical skills'
  • Experience managing personnel (internal FTEs or vendor management)
  • Education and Experience:
  • Bachelor's degree, with a preference for life sciences or technology area

Compensation

  • $192,000 - $288,000
  • The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting.
  • This role is eligible for an annual bonus and annual equity awards.
  • Some roles may also be eligible for overtime pay, in accordance with federal and state requirements.
  • Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

Benefits

  • This role is eligible for an annual bonus and annual equity awards.
  • Lead the Regulatory Data Management function, setting the vision, operating model, priorities, and performance expectations for regulatory data governance, data quality, and regulatory information reporting.

Company info

  • The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.
  • Company Information
  • Vertex is a global biotechnology company that invests in scientific innovation.
  • Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.
  • Vertex is an E-Verify Employer in the United States.
  • Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
  • Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
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