Associate Director, Regulatory Publishing (Remote)Job 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. In addition, the role will work with stakeholders and project teams for the timely delivery of content to be published, as well as advise on standards and expectations of format. The role is responsible for the accuracy of published output to Vertex and industry standards and health authority requirements. The Regulatory Publishing Associate Director will be responsible for evaluating and prioritizing process improvement initiatives and working with technical/system groups to drive process improvements for the accurate and quality driven execution of submissions.
Key Duties and Responsibilities: Manages portfolio views of upcoming submissions and publishing interdependenciesLeads activities involving submission managers and regulatory leads for submission preparation and timelinesManages Outsourcing activities with appropriate vendorsCollaborates with GIS to ensure technical efficiency of publishing systemsCollaborates across the Regulatory and cross functional teams to develop process improvement plans with respect to the publishing areaRequires specialized knowledge and ability to advise on the regulations and processes that govern the content and maintenance of controlled documents required by the Health Authorities and ICHDevelops and confirms that all components of defined submissions in the required format as per health authority guidanceKnowledge and Skills: Extensive experience in industry standard publishing software and validation systemsVendor management/outsourcing experienceAbility to prioritize portfolio of publishing activities on selected programsAbility to train and educate other team members and influence cross functional stakeholders in submission ready conceptsAbility to work with firm deadlines and adapt quickly to changing requirements and prioritiesStrong organization, written/verbal communication, and attention to detailKnowledge of health authority procedures/guidance regarding electronic submissions.Expert in Electronic Document Management Systems.Education and Experience: Bachelor's Degree in life sciences or technology areaTypically requires 9 years of Regulatory Operations/Publishing experience or the equivalent combination of education and experience.Pay Range: $150,400 - $225,600 USD annually
Flex Designation: Remote-Eligible
Flex Eligibility Status: In this Remote-Eligible role, you can choose to be designated as:
Remote: work remotely five days per week and come into the office on occasion – you're always welcome on-site;Hybrid: work remotely up to two days per week;On-Site: work five days per week on-site with ad hoc flexibility.Company Information Vertex is a global biotechnology company that invests in scientific innovation.
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