Aptive seeks an experienced and detail-oriented Project Manager to lead and oversee the FDA’s Center for Drug Evaluation and Research (CDER) Office Business Informatics (OBI) Submission Data Support Initiative. This role plays a critical role in supporting OBI as they continue to implement and maintain the Integrated Electronic Submission Support (IESS) systems and processes. The Project Manager will ensure effective task execution, stakeholder communication, reporting and quality management across all support activities.

The ideal candidate has FDA CDER OBI expertise and is familiar with IESS systems. 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.
• Experience coordinating and facilitating kickoff, monthly, weekly, and ad hoc meetings and documenting outcomes.
• Experience writing and maintaining a comprehensive Project Management Plan (PMP) addressing change control, risk mitigation, quality management, staffing plans, and reporting.
• Experience overseeing the execution of tasks related to IT help desk support, training coordination, data profiling, and validation initiatives.
• Must meet U.S. residency requirement (3 of last 5 years) and be eligible for Tier 2Public Trust clearance.

• 10+ years of relevant project management experience, preferably in a federal health-related programs (preferably FDA)
• Bachelor’s degree in Public Health, Business Administration, IT or other related field.
• Certification in Project Management (i.e., PMP) required.
• Strong domain and technical architecture experience.
• Proven experience with Agile project delivery and FDA regulatory data submissions (e.g., eCTD 3.2.2/4.0)
• Strong understanding of tools and platforms including Microsoft SharePoint, Excel, Outlooks and COTS submission validation tools.
• Familiarity with FDA data standards (e.g., CDISC, SEND, HL7) and regulatory requirements
• Experience coordinating with security and privacy teams and ensuring compliance with FISMA, NIST, and FDA-specific security requirements

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.