Associate Director – Regulatory Project Management
Vertex Pharmaceuticals
contract
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $90 - $100 per hour
Job Level
Senior
About the role
- Responsible for the planning, managing and tracking of the regulatory portfolio of submissions across a number of assigned programs
- Driving comprehensive plans and reports that would include all major milestones and other key dates related to the filings
- Focus on achieving regulatory submission activities and driving the broader GRA team to ensuring all deliverables are met
- Responsible for driving timeline risk mitigation and contingency planning
- 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
- May have financial accountabilities and human resource responsibilities for assigned staff
Requirements
- Bachelor’s degree in life sciences or technology area
- 10+ years of project management experience in regulatory/clinical project management or project management experience in a life sciences company
- 2 years of supervisory/management experience, or the equivalent combination of education and experience
- 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
- Stakeholder management skills
- Supervisory/management 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
- Overtime pay eligibility in accordance with federal and state requirements
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
project managementregulatory submission activitiesrisk mitigationcontingency planningproject planningstatus reportingissue resolutionresource managementbudget managementdata-driven decision making
Soft skills
organizationcommunicationattention to detailstakeholder managementleadershipadaptabilityproblem-solvingteam managementstrategic planningtime management