Senior Manager of Regulatory Publishing

Overview

The Senior Manager of Regulatory Publishing is responsible for the creation, assembly, and publishing of electronic submissions and the delivery to global health authorities in an efficient and timely manner. The role 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. This person can lead complex submission work across programs.

This role will work with stakeholders and project teams for the timely delivery of content to be published, as well as drive for project teams the standards and expectations of format. This role is responsible for the accuracy of published output to Vertex and industry standards and health authority requirements. This person will be responsible for leading process improvements to ensure accurate and quality driven execution of submissions.

• Works independently within the publishing/content systems to create published output for submission
• Creates and assembles all components of defined submissions in required format as per health authority guidance
• Validates submissions through the application of acquired experience
• Manage portfolio views of upcoming submissions and publishing interdependencies
• Collaborates with submission managers and regulatory leads for submission preparation and timelines
• Liaises with functional source areas to ensure documents are compliant and submission ready
• Collaborates with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications
• Requires a good understanding and the ability to advise of the regulations and processes that govern the content and maintenance of controlled documents required by the Health Authorities and ICH
• Responsible for periodical testing of system improvements/HA updates within publishing environment

• Experience in industry standard publishing software and validation systems
• Knowledge of types of Global HA submissions and their requirements and guidelines
• Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
• Ability to prioritize portfolio of publishing activities on programs
• Ability to educate and train other team members and influence cross functional stakeholders in submission ready concepts
• Strong organization, written/verbal communication, and attention to detail
• Knowledge of health authority procedures/guidance regarding electronic submissions
• Highly skilled in use of Electronic Document Management Systems
• Ability to balance multiple tasks to meet priorities and timelines

• Bachelor’s Degree in life sciences or technology area
• Typically requires 7 Years of eCTD publishing experience or the equivalent combination of education and experience

Through the end of the year, with the chance to extend

$85/hr-$92/hr

Monday - Friday

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third-party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting.

The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements

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