Associate Director – Regulatory Project Management

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Vertex Pharmaceuticals

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Biotechnology • Pharmaceuticals • Healthcare Insurance

Vertex Pharmaceuticals is a global biotechnology company focused on creating transformative medicines for people with serious diseases. With a commitment to scientific innovation, Vertex engages in the discovery, development, and production of cutting-edge therapies, particularly for conditions such as cystic fibrosis, sickle cell disease, and pain management. The company also emphasizes corporate responsibility and diversity within its inclusive culture to drive innovation and improve patient lives.

1001 - 5000 employees

Founded 1989

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• 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