Job description

Job Description

14 month contract

Hybrid or remote working available

General Summary:

The Associate Director, Regulatory Submission Management is responsible for the planning, managing and tracking of the regulatory portfolio of submissions across a number of assigned programs. This role will be responsible for driving comprehensive plans and reports that would include all major milestones and other key dates related to the filings. The role will focus on achieving regulatory submission activities and driving the broader GRA team to ensuring all deliverables are met. This role will be responsible for driving timeline risk mitigation and contingency planning.

Key Duties and Responsibilities:

Oversees complex project and portfolio plans from project initiation to closeout.
Drives the definition of the project milestones, tasks, deliverables, key dependencies and resource requirements.
Oversees the development of project plans, status reports, issue logs, and other project-related artifacts.
Leads strategies for risk mitigation and contingency planning within plan. Efficiently identifies and resolves project issues within the team and drives the resolution to completion.
Manages project status, issues, schedule and accomplishments and communicates to various management and stakeholder groups, as needed.
Leads and manages members of submission management team.
Leads the preparation of necessary reports to drive data-driven resource, budget and trade-off discussions across the GRA function.
As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff.

Knowledge and Skills:

Expertise in global regulatory filing project management
Expertise in project management tools
Comprehensive understanding of types of Global HA submissions and requirements and guidelines
Ability to drive firm deadlines and adapt quickly to changing requirements and priorities
Excellent organization, written/verbal communication, and attention to detail to persuade managers and leaders to take action
Stakeholder management skills
Ability to balance multiple tasks to meet priorities and timelines
Supervisory/management experience

Education and Experience:

Bachelor’s degree in life sciences or technology area
Requires project management experience in regulatory/clinical project management or project management experience in a life sciences company and supervisory/management experience, or the equivalent combination of education and experience

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Flex Designation:

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s 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 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.

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 ApplicationAssistance@vrtx.com