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Regulatory Submission Management Manager

Company: Vertex Pharmaceuticals
Location: Boston
Posted on: June 26, 2022

Job Description:

Job DescriptionGeneral Summary:The Regulatory Submission Management Manager is responsible for the planning, managing and tracking of the regulatory portfolio of submissions for an assigned program. This role will be responsible for maintaining comprehensive plans and reports that would include all major milestones and other key dates related to the filings. The plans would be used within regulatory to plan submission activities and resources. In addition, the plans will need to be integrated cross-functionally to ensure project team alignment on major milestones. This role will be responsible for facilitating timeline risk mitigation and contingency planning within plan. This role will work with key functions to collect the latest dates, understand the change drivers, update the plan and run and distribute reports to the various stakeholders.Key Duties and Responsibilities:

  • Manages project plans from project initiation to closeout.
  • Facilitates the definition of the project milestones, tasks, deliverables, key dependencies and resource requirements
  • Maintains project plans, status reports, issue logs, and other project-related artifacts.
  • Assists in facilitating strategies for risk mitigation and contingency planning within plan.
  • Identifies and resolves project plan issues using technical expertise.
  • Communicates project status, complex issues, schedule and accomplishments to various management and stakeholder groups, as needed.
  • Contributes to the preparation of necessary reports to drive data-driven resource, budget and trade-off discussions across GRA functionKnowledge and Skills:
    • Experience in regulatory filing project management
    • Expertise in project management tools
    • 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
    • Excellent organization, written/verbal communication, and attention to detail to exchange complex information with others in complex situations
    • Stakeholder management skills
    • Ability to balance multiple tasks to meet priorities and timelines.Education and Experience:
      • Bachelor's degree in life sciences or technology area
      • Typically 4 years of project management experience in regulatory/clinical project management or in a life sciences company or the equivalent combination of education and experienceWe're enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid- or On-Site-Eligible role, you can choose to work:1. Hybrid and work remotely up to two days per week on regularly scheduled days; or select2. On-Site work 5 days per week with ad hoc flexibility.
        #LI-EE1 #LI-HybridCompany InformationVertex 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.Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. 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

Keywords: Vertex Pharmaceuticals, Boston , Regulatory Submission Management Manager, Executive , Boston, Massachusetts

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