Atrium ยท 11 hours ago
Associate Director - Regulatory Project Management (Contract) 27647
Atrium is a company seeking an Associate Director for Regulatory Submission Management. This role is responsible for planning, managing, and tracking regulatory submissions, ensuring all deliverables are met, and driving risk mitigation strategies.
Real Estate
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
Qualification
Required
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
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
Benefits
Medical benefits
Fringe benefits
Overtime pay
Company
Atrium
Atrium is a global WBENC-certified Talent Solutions and Extended Workforce Management leader.
H1B Sponsorship
Atrium has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (2)
2020 (4)
Funding
Current Stage
Growth StageLeadership Team
Company data provided by crunchbase