Job Description

General Summary:
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 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.

Knowledge and Skills:

• 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.

Education and Experience:

• Bachelor's Degree in life sciences or technology area or equivalent experience
• Typically requires 9 years of Regulatory Operations/Publishing experience or the equivalent combination of education and experience.

Flex Designation: Remote-Eligible
Flex Eligibility Status:
In this Remote-Eligible role, you can choose to be designated as:
1. Remote: work remotely five days per week and come into the office on occasion - you're always welcome on-site; or select
2. Hybrid: work remotely up to two days per week; or select
3. On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

Skills Required