Jobs at CICONIX, LLC

Supports regulatory risk, quality management, knowledge management, and clinical research compliance for FDA-regulated medical products. Responsibilities include developing quality systems and SOPs, managing training compliance, preparing submissions and audit plans, conducting audits and inspections, investigating nonconformances, implementing CAPAs, performing ISO 14971 risk management, reviewing documentation and facilities, and providing regulatory and quality training to internal staff, clinical sites, CROs, CMOs, and other supported entities.

Manages inbound and outbound shipments, receiving, storage, distribution, property accountability, medical supplies, and equipment turn-ins for a military medical research organization. Maintains logistics records and databases, coordinates vendors and deliveries, processes procurement requests, supports shipping accounts, performs material handling, and prepares reports and administrative documents. Requires adherence to storage, safety, PPE, packaging, and government logistics procedures.

Supports the Defense Health Agency Medical Simulation and Training PMO through acquisition documentation, market research, contract and solicitation reviews, requirements analysis, funding compliance, program scheduling, IPT coordination, meeting support, action tracking, and SharePoint configuration management. The role also assists with proposal evaluations, acquisition planning, scope and cost estimates, document quality control, and maintaining program records in accordance with DHA, DoD, and federal acquisition policies.

Coordinates administrative and operational support for a military health research office. Responsibilities include staff onboarding and offboarding, tasker tracking, meeting support, supply and equipment requests, emergency accountability, property inventories, asset turn-ins, acquisition support, market research, and government system access documentation. The role requires effective communication, prioritization, multitasking, U.S. citizenship, a successful background investigation, and eligibility for a government security clearance.

Supports the Defense Health Agency Medical Simulation and Training PMO through military capability analysis, organizational assessment, medical training requirements research, and advisory support for simulator testing and evaluation. Maintains technical data repositories, assists with inspections, diagnostics, acceptance testing, deliveries, inventory documentation, and contractor status reporting. Requires an active Secret clearance and supports medical simulation and training program activities in an on-site Orlando environment.

Supports investigational product development and manufacturing compliance across the product lifecycle. Responsibilities include CMC and GMP support, product accountability, storage and shipment oversight, formulation and specification development, document and regulatory submission review, analytical method validation, facility audits, deviation and CAPA management, temperature excursion investigations, and Trial Master File maintenance for military health research programs.

Provides administrative support to the Office of Regulated Activities at Fort Detrick. Responsibilities include calendar and roster management, meeting and event coordination, travel tracking, protocol board support, document preparation, records maintenance, visitor access, supply purchasing, and administrative process guidance. Requires five years of administrative experience, proficiency with Microsoft Office, U.S. citizenship, successful background investigation, and ability to obtain and maintain a government security clearance.

Senior Advisor supporting the Defense Health Agency Medical Simulation and Training PMO. Advises on acquisition strategy, budgets, schedules, performance, strategic planning, program documentation, risk management, milestone reviews, congressional and senior-leadership briefings, and communications. Coordinates stakeholders across DHA, military services, OSD, Congress, and industry; conducts portfolio analyses, develops courses of action, prepares reports and briefings, and supports enterprise-level planning for medical simulation programs.

Supports the Defense Health Agency Medical Simulation and Training PMO with financial planning, cost estimates, budget development, execution tracking, reconciliation, and reporting. Maintains funding and accounting data across contracts, manpower, travel, training, and other program activities. Prepares financial analyses, audit documentation, management reports, and out-year manpower projections while monitoring obligations, commitments, disbursements, and potential funding issues.

Provides senior biostatistical and clinical data management support for military health research programs. Responsibilities include developing data management, statistical analysis, randomization, and validation plans; creating statistical programming specifications; producing tables, listings, and figures; developing CDISC-compliant SDTM, ADaM, and SEND datasets; preparing reviewer guides and define files; and responding to sponsor and FDA queries.

Supports office management and administrative operations for the Defense Health Agency Medical Simulation and Training PMO. Responsibilities include correspondence, records, travel orders and vouchers through DTS, scheduling, visitor and clearance requests, presentations, supplies, facility work requests, mail, onboarding, training tracking, awards, and emergency preparedness. The role is on-site in Orlando, requires an active Secret clearance, and is contingent on contract award.

Develop and maintain statistical analysis and programming validation plans, randomization programs, clinical study tables, listings, and figures. Create CDISC-compliant SDTM, ADaM, and SEND datasets, define.xml and define.pdf documentation, reviewer’s guides, and responses to sponsor and FDA queries. The role supports regulated military health research activities at Fort Detrick and requires U.S. citizenship, background investigation, and eligibility for a government security clearance.

Supports Defense Health Agency systems through cybersecurity certification and accreditation, RMF assessment and authorization, security documentation, vulnerability management, configuration management, audit reviews, and STIG compliance. Conducts self-assessments, vulnerability scans, POA&M development, and eMASS documentation to support IATT and ATO decisions. Coordinates with authorizing officials, system administrators, and cybersecurity personnel to maintain system security posture and accreditation compliance.

Supports the DHA Medical Simulation and Training PMO with technical publication tracking, logistics requirements, inventory and property management, equipment accountability, warehousing, audits, procurement documentation, and materiel fielding. Maintains publication updates, tracks medical simulation equipment, develops logistics inputs for RFIs and PWSs, and enters CDRLs into CDRLvue. The role is on-site in Orlando and requires an active Secret clearance and U.S. citizenship.

Prepares, publishes, quality reviews, and submits regulatory dossiers for drug, biologic, device, and combination products. Maintains audit-ready regulatory files, Trial Master Files, electronic filing records, and paper archives. Supports FDA submissions, regulatory mailbox administration, document control, validation reporting, and external partner guidance. The role requires five years of administrative experience, Microsoft Office proficiency, U.S. citizenship, a successful background investigation, and eligibility for a government security clearance.