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 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.

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 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
• Expertise in using Veeva Rim for content plan submissions
• 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
• 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 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

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 Vertex's 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 employment-related information, as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners

(collectively, "Atrium Alerts"). Atrium Alerts may be sent by email, phone, or text message. Your personal information will be safely stored within the Atrium & Vertex databases. Atrium does not sell your personal information to third parties. Text message and data rates may apply. To OPT OUT of text messaging or to modify your communication preferences for Atrium Alerts at any time, please contact Atrium at [email protected].

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 [email protected]. Please include the job title in the subject of your email.

No C2C or Third-Party Vendors