Aptive seeks an experienced Project Manager to lead and coordinate the development and implementation of high-impact educational materials supporting rare disease drug development in collaboration with FDA’s Center for Drug Evaluation and Research (CDER). This position will play an important role in supporting the Rare Diseases Team (RDT) and the Rare Disease Innovation Hub under the Accelerating Rare disease Cares (ARC) program.

The ideal candidate has FDA CDER expertise and is familiar with their administrative and program execution activities. They have previous experience leading projects and are highly organized and systematic in their project work. They exceed client expectations with high-quality work in a fast-paced environment.

• Proven ability to lead large, cross-functional teams while maintaining excellent written and verbal communication with internal and external stakeholders.
• Strategic thinker with a drive to execute a wide variety of tasks and deliverables with a high attention to detail.
• Experience managing end-to-end project lifecycles, including planning, resource coordination, scheduling and risk mitigation.
• Excellent understanding of educational development, regulatory environments, and stakeholder engagement strategies.
• Adept coordinating meeting logistics, including the preparation of agendas, summaries, key decisions and action items.
• Certification in Project Management (e.g., PMP) strongly preferred.
• Must meet U.S. residency requirement (3 of last 5 years) and be eligible for Public Trust clearance.

• 5+ years of relevant project management experience, preferably in a federal health, scientific, or regulatory environment
• Bachelor’s degree in Public Health, Regulatory Affairs, Education, Business Administration or other related field.
• Experience supporting large, complex projects for federal agencies; FDA preferred.

Aptive is a modern federal consulting firm focused on human experience, digital services, and business transformation. We harness creativity, technology, and culture to connect people and systems to impact the world. We’re advisors, strategists, and engineers focused on people, above all else.

We believe in generating success collaboratively, leaving client organizations stronger after every engagement and building trust for the next big challenge.

Our work inspires people, fuels change and makes an impact. Join our team to be part of positive change in your community and our nation.