Associate Director - Regulatory Project Management (Contract) - Remote

Overview

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.

In Short

• 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.
• Manages project status, issues, schedule and accomplishments and communicates to various management and stakeholder groups.
• Leads and manages members of submission management team.
• Leads the preparation of necessary reports to drive data-driven resource, budget and trade-off discussions.
• May have financial accountabilities and human resource responsibilities for assigned staff.

Requirements

• Bachelor’s degree in life sciences or technology area.
• Typically requires 10+ years of project management experience in regulatory/clinical project management.
• 2 years of supervisory/management experience.
• Expertise in global regulatory filing project management.
• Expertise in project management tools.
• Expertise in using Veeva Rim for content plan submissions.
• Excellent organization, written/verbal communication, and attention to detail.
• Ability to balance multiple tasks to meet priorities and timelines.

Benefits

• Competitive hourly pay rate.
• Eligibility for overtime pay.
• Opportunity to work remotely.
• Engagement with a leading life sciences company.