Regulatory Publishing Senior Manager (Contract)

Vertex Pharmaceuticals; Boston (MA); On-site; USD 117,096 - 126,739; Full time

Job summary

Vertex Pharmaceuticals in Boston is seeking a Regulatory Publishing Senior Manager to lead the creation, assembly and publishing of electronic submissions for global health authorities, delivering accurate content on schedule.

You will manage a portfolio of submissions, coordinate with regulatory document authors and submission managers, and drive process improvements ensuring compliant, high-quality output across programs.

Qualifications

• Bachelor’s degree in life sciences or technology field is required.
• 7 years of eCTD publishing experience is typically required.
• Experience with regulatory publishing processes and HA submissions.

Responsibilities

• Creates published output for submissions and assembles components per health authority guidance.
• Validates submissions and manages interdependencies across program portfolios.
• Collaborates with submission managers and regulatory leads to meet timelines.

Skills

eCTD publishing experience

Regulatory publishing software

Health authority guidelines

Portfolio management

Cross-functional collaboration

Attention to detail

EDMS usage

Education

Bachelor’s Degree in life sciences or technology

Job description

Job Description

The Regulatory Publishing Senior Manager 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. 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. The Regulatory Publishing Senior Manager will be responsible for leading process improvements for the accurate and quality driven execution of submissions.

Key Duties and Responsibilities:

• 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

Knowledge and Skills:

• 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's regarding electronic submissions
• Highly Skilled in use of Electronic Document Management Systems
• Ability to balance multiple tasks to meet priorities and timelines

Education and Experience:

• 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

Contract Length: 12 months, with the chance to extend

Pay Range

$85/hr.-$92/hr.

Shift/Hours

Monday - Friday

No C2C or Third-Party Vendors