Aptive seeks an experienced Project Manager to support the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER). The Project Manager will plan, execute, and oversee the day-to-day operations of complex, multi-disciplinary efforts designed to enhance business, research, and clinical operations in alignment with FDA’s mission to protect public heProalth. The Project Manager will serve as the primary liaison between project teams and FDA leadership, ensure the timely execution of deliverables, and manage to optimize efficiency, innovation and regulatory outcomes.

The ideal candidate has FDA CDER expertise and is familiar with their administrative and clinical research 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.

• 5+ years of relevant project management experience, preferably in a federal health or research environment
• Bachelor’s degree in Public Health, Regulatory Affairs, Life Sciences, Business Administration or other related field.
• Experience supporting large, complex projects for federal agencies; FDA preferred.
• Proficiency with Microsoft Office Suite, SharsPoint, Power Automate, PowerBI and other project management tools.

• Proven ability to lead large, cross-functional teams while maintaining excellent written and verbal communication with diverse 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 lifecycle of regulatory science and clinical research projects, including planning, resource coordination, scheduling and risk mitigation.
• Adept directing administrative support activities, including meeting logistics, documentation, stakeholder communications, and recurring task reminders.
• Able to synthesize programmatic data to support strategic plan execution and recommendations for business process improvements and technology solutions to streamline operations.
• Strong written communications skills with experience drafting SOPs, strategic plans, concept papers, protocols and/or journal submissions.
• Certification in Project Management (e.g., PMP) strongly preferred.

Aptive is a management consulting firm based in Alexandria, Virginia. With more than 500 employees across the U.S., we primarily support the federal government – more than a dozen agencies like Veterans Affairs, Transportation, Defense, Library of Commerce, Customs and Border Protection and the National Science Foundation. Our work focuses on applying creativity, technology and human-centered services to improve performance, bridge divides and elevate the lives of millions of people who count on government. services every day. 

Aptive is an equal opportunity employer. We consider all qualified applicants for employment without regard to race, color, national origin, religion, creed, sex, sexual orientation, gender identity, marital status, parental status, veteran status, age, disability, or any other protected class.

Veterans, members of the Reserve and National Guard, and transitioning active-duty service members are highly encouraged to apply.