Associate Director - Regulatory Project Management (Contract) 24525 jobs in United States
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Atrium ยท 1 month ago

Associate Director - Regulatory Project Management (Contract) 24525

Atrium is a staffing agency seeking an Associate Director for Regulatory Submission Management. This role is responsible for planning and managing the regulatory portfolio of submissions, ensuring deliverables are met, and leading the submission management team.

Real Estate
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Growth Opportunities
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H1B Sponsor Likelynote

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

Regulatory project managementVeeva RimProject management toolsGlobal HA submissionsStakeholder managementSupervisory experienceCommunication skillsOrganizational skills

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

Compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer.
This role will be eligible for overtime pay, in accordance with federal and state requirements

Company

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 Stage

Leadership Team

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Caylon Joiner
Talent Acquisition Partner
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Shannon Mooney
Managing Director, Strategic Partnerships
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Company data provided by crunchbase