Job Description
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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.
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