Axiom is seeking a Senior Program Management Specialist to support a high-visibility project for a program leading the Department's enterprise for developing, acquiring, and fielding next-generation medical capabilities that enhance Warfighter lethality, survivability, and readiness. This contract provides comprehensive Product Management and Support Services across the full spectrum of medical product development, spanning administrative, financial, technical, regulatory, and clinical advisory functions. Through structured lifecycle management, stakeholder engagement, and mission-focused support, this effort ensures that medical solutions are effectively developed, integrated, and transitioned to meet the operational demands of modern combat environments. The successful candidate will provide regulatory-affairs support across medical product development, helping teams interpret regulatory requirements, develop regulatory strategies, prepare submissions, manage regulatory interactions, and identify compliance risks. Responsibilities Provide regulatory guidance for drugs, biologics, medical devices, blood products, and other military-relevant medical solutions. Support regulatory strategy, submission planning, dossier preparation, and communication with regulatory agencies. Review and interpret FDA regulations, guidance, DoD/DHA directives, and relevant industry standards and assess impacts on assigned programs. Prepare or review regulatory submissions and supporting packages, including INDs, NDAs, PMAs, 510(k)s, technical files, clinical evaluation reports, meeting packages, audit reports, and inspection materials as applicable. Support regulatory-agency interactions, sponsor communications, responses to queries, and management of regulatory commitments. Conduct gap analyses and recommend corrective or preventive actions to address regulatory deficiencies. Review clinical protocols, investigator brochures, safety information, progress reports, and surveillance data for regulatory implications. Support future clinical-trial and preclinical planning and integrate regulatory milestones into master plans and schedules. Advise Product Managers, IPTs, and leadership regarding regulatory risks, opportunities, and issues. Requirements Advanced professional communication, briefing, writing, coordination, and stakeholder-engagement skills. Ability to synthesize complex technical, programmatic, financial, regulatory, and operational information into actionable recommendations. Ability to manage multiple concurrent priorities, suspense dates, taskers, meetings, and deliverables. Proficiency with Microsoft 365 applications appropriate to assigned work; advanced proficiency is expected for many program-management and coordination functions. Ability to work effectively in matrixed DoD environments with military, civilian, contractor, academic, industry, and Federal stakeholders. FDA regulatory strategy and submission knowledge. Strong analytical, writing, and regulatory-document review skills. Cross-functional collaboration with clinical, R&D, manufacturing, quality, and program-management personnel. Progressive regulatory-affairs experience in drugs, biologics, devices, blood products, or other regulated medical products. Demonstrated experience with FDA submissions and regulatory interactions. DoD medical acquisition experience is strongly preferred. Additional Preferred Qualifications Perform assigned work independently and professionally while maintaining close coordination with Government stakeholders and the applicable PMO/Division. Produce accurate, timely, review-ready work products and maintain complete, retrievable records in designated systems. Apply applicable DoD, DHA, Service, Federal, regulatory, and local policies and procedures to all assigned activities. Communicate contractor status appropriately and protect sensitive, acquisition-sensitive, CUI, proprietary, PII/PHI, and classified information as applicable

Pay:

$70,000.00 - $80,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Employee assistance program Flexible spending account Health insurance Life insurance Paid time off Tuition reimbursement Vision insurance

Work Location:

Hybrid remote in Fort Detrick, MD 21702