Associate Director - Regulatory Project Management Contract 24525
Associate Director - Regulatory Project Management Contract 24525
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Job Description
Job Description
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 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.
This is a remote role Eastern time zone work hours
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 projectrelated 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 datadriven resource budget and tradeoff 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:
- Bachelors degree in life sciences or technology area
- Typically requires 10 years of project management experience in regulatory/clinical project management or project management experience in a life sciences company and 2 years of supervisory/management experience or the equivalent combination of education and experience
Pay Range
$90$100/hr
Requisition Disclaimer
This job posting is for a temporary role with a thirdparty 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 thirdparty 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 jobrelated factors permitted by law. In addition this role will be eligible for overtime pay in accordance with federal and state requirements
By applying for this position you agree to the Atrium Terms and Conditions and you direct Atrium to share your application materials which may include your CV/Resume email address or phone number with Vertex. For more information on how Vertex handles your personal data related to your job application please see Vertexs Careers Privacy Notice. Agreeing to the Atrium Terms and Conditions includes permission to use the email address and mobile phone number you provide during the application process or throughout the duration of your prospective or actual employment to notify you of job openings profiles articles news and other employmentrelated information as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners
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If you do not agree with the Atrium Terms and Conditions you can still complete your application for this position by emailing your resume to our team at Please include the job title in the subject of your email.
No C2C or ThirdParty Vendors
Required Experience:
Director
Employment Type
Remote
