[Hiring] Associate Director, Regulatory Publishing @Atrium Works

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. 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. Apply tot his job Apply To this Job