Associate Director, Regulatory Publishing (Contract)

Vertex Pharmaceuticals

1d•Remote

About The Position

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.

Requirements

Bachelor’s Degree in life sciences or technology area
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's regarding electronic submissions.
Expert in Electronic Document Management Systems.

Responsibilities

Manages portfolio views of upcoming submissions and publishing interdependencies and serves as Global Regulatory Publishing subject matter expert
Serve as primary point of contact between cross-functional team and regulatory publishing vendor.
Monitor vendor KPIs, SLAs, and quality metrics; escalate performance issues or capacity constraints.
Stay current on regulatory publishing trends and best practices, and assess implications for internal processes and vendor partnerships and ensure vendor adherence to company SOPs, global regulatory requirements, and evolving health authority guidance.
Partner with cross-functional teams to develop and manage submission publishing timelines, publishing strategy, and resource forecasting.
Ensure submission content is tracked, compiled, validated, and delivered in the required format in compliance with regional requirements.
Perform quality control (QC) reviews on vendor work to ensure submission content meets regulatory and internal standards.
Lead or contribute to the development and continuous improvement of publishing processes, templates, checklists, and SOPs.
Participate in cross-functional or global working groups focused on submission process innovation or regulatory technology and provide training or guidance to stakeholders on publishing timelines and requirements.
Contribute to long-term resource planning, including publishing capacity needs.