Associate Director Regulatory Publishing

Toronto - Canada

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

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 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/guidances regarding electronic submissions.
Expert in Electronic Document Management Systems.

Education and Experience:

Bachelors 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 youre 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 Vertexs 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 persons 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

Required Experience:

Director

Job DescriptionGeneral 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...