Vertex Pharmaceuticals

Associate Director, Regulatory Publishing

Vertex Pharmaceuticals

contract

Posted on:

Location Type: Remote

Location: United States

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Job Level

Senior

About the role

  • Accountable for leading publishing activities on a portfolio level
  • Responsible for the maintenance and lifecycle management submissions
  • Lead complex submission work across programs
  • Ensure submission content is tracked, compiled, validated, and delivered in the required format
  • Perform quality control (QC) reviews on vendor work
  • Contribute to long-term resource planning, including publishing capacity needs

Requirements

  • Requires Bachelor’s Degree in life sciences or technology area
  • Typically requires 9 years of Regulatory Operations/Publishing experience or equivalent combination of education and experience
  • Extensive experience in industry standard publishing software and validation systems
  • Vendor management/outsourcing experience
  • Ability to prioritize portfolio of publishing activities on selected programs
  • Ability to train and educate other team members
  • Knowledge of health authority procedures/guidances regarding electronic submissions
Benefits
  • Health insurance
  • 401(k) matching
  • Flexible work arrangements
  • Opportunity for professional development
  • Overtime pay
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Regulatory OperationsPublishingQuality ControlLifecycle ManagementSubmission ManagementValidation SystemsVendor Management
Soft Skills
LeadershipPrioritizationTrainingEducation
Certifications
Bachelor’s Degree