Job Description
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
- Leads activities involving submission managers and regulatory leads for submission preparation and timelines
- Manages Outsourcing activities with appropriate vendors
- Collaborates with GIS to ensure technical efficiency of publishing systems
- Collaborates across the Regulatory and cross functional teams to develop process improvement plans with respect to the publishing area
- Requires specialized knowledge and ability to advise on the regulations and processes that govern the content and maintenance of controlled documents required by the Health Authorities and ICH
- Develops and confirms that all components of defined submissions in the required format as per health authority guidance
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 regarding electronic submissions.
- Expert in Electronic Document Management Systems.
Education and Experience:
- Bachelor's Degree in life sciences or technology area
- Typically requires 9 years of Regulatory Operations/Publishing experience or the equivalent combination of education and experience.
Pay Range: $150,400 - $225,600
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.
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.
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