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Role Description

The Regulatory Publishing Associate Director is accountable for leading publishing activities on a portfolio level and responsible for the maintenance and lifecycle management submissions that are inter-related and dependent on multiple concurrent submissions. The role will lead complex submission work across programs and provide oversight and planning of outsourced activities.

• Work with stakeholders and project teams for the timely delivery of content to be published
• Advise on standards and expectations of format
• Responsible for the accuracy of published output to Vertex and industry standards and health authority requirements
• Evaluate and prioritize process improvement initiatives
• Work with technical/system groups to drive process improvements for accurate and quality-driven execution of submissions

Qualifications

• Bachelor’s Degree in life sciences or technology area

Requirements

• Typically requires 9 years of Regulatory Operations/Publishing experience or the 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 and influence cross-functional stakeholders in submission ready concepts
• Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
• Strong organization, written/verbal communication, and attention to detail
• Knowledge of health authority procedures/guidance regarding electronic submissions
• Expert in Electronic Document Management Systems

Benefits

• Pay dependant upon experience
• Eligible for overtime pay, in accordance with federal and state requirements

Contract Length

• Through the end of the year, with the chance to extend

Shift/Hours

• Monday - Friday. EST hours. Remote.