Senior Manager, Regulatory Submission Management (Contract) 23187
Job Description:
The Regulatory Submission Management Senior 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 developing 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 identifying timeline risk mitigation and contingency planning within plan.
This role will collaborate 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 & Responsibilities- Leads complex project plans from project initiation to closeout.
- Facilitates the definition of the project milestones, tasks, deliverables, key dependencies and resource requirements.
- Develops complex project plans, status reports, issue logs, and other project-related artifacts.
- Identifies facilitating strategies for risk mitigation and contingency planning within plan.
- Identifies and resolves complex project plan issues and takes a new perspective on existing solutions.
- Communicates project status, difficult or sensitive issues, schedule and accomplishments to various management and stakeholder groups, as needed, and works to build alignment
- Prepares necessary reports to drive data-driven resource, budget and trade-off discussions across GRA function
- Bachelor’s degree in life sciences or technology area
- Typically requires 6 years of project management experience in regulatory/clinical project management or project management experience in a life sciences company, or the equivalent combination of education and experience
- Experience in regulatory filing project management
- Expertise in project management tools
- In-depth conceptual knowledge of types of Global HA submissions and 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 explain difficult information and works to build alignment
- Stakeholder management skills
- Ability to balance multiple tasks to meet priorities and timelines
Pay Range:
$85-$95/hr
Requisition Disclaimer:
This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer.The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law.
In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements
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