Duration: 4 months to start
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 thew organization 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
General Summary:
- 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
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
