Type of Requisition: Regular Clearance Level Must Currently Possess: None Clearance Level Must Be Able to Obtain: None Public Trust/Other Required: NACI (T1) Job Family: Program Management Job Qualifications: Skills: Clinical Protocol, FDA Regulations, Protocol Management Certifications: None Experience: 8 + years of related experience US Citizenship Required: Yes Job Description: Seize your opportunity to make a personal impact as a Senior Program Management Analyst (Science Field) supporting Defense Health Agency (DHA) Operational Medicine (OPMED). GDIT is your place to make meaningful contributions to challenging projects and grow a rewarding career. Our work depends on a Senior Program Management Analyst joining our team and utilizing their experience and science background to ensure the medical countermeasures and treatments follow DoD requirements and able to meet the acquisition timeline to make is way to the Warfighter. HOW YOU WILL MAKE AN IMPACT: * Provide program/project management support to assigned IND medical products. * Apply pertinent laws, regulations, policies, procedures, and work processes to requirements involving the major issues and goals and objectives for force health protection missions. * Work with the DHA Office of Regulatory Activities (ORA) to develop necessary regulatory documents and ensure IND protocols meet all regulatory requirements, such as supporting submission of documents for FDA. * Interact with SMEs, appropriate IRBs, to gain IRB approval. * Provide storage, protocol management, and oversee product release for FHP IND products entrusted to their care. * Coordinate with multiple stakeholders to gather and analyze technically complex information, project management of therapeutics, prophylactics, diagnostics, and management of clinical protocols. * Participate in Integrated Product Teams (IPTs) and working group meetings, as required. * Coordinate meetings, lead working groups, develop and/or edit meeting minutes, develop technical reports, and assist with other tasks and deliverables as required. * Support numerous efforts and effectively prioritize and multi-task on requirements that have a direct impact on the portfolio. * Communicate with personnel at various echelons through the use of effective interpersonal and communication skills. * Participate in special projects, as required. WHAT YOU NEED TO SUCCEED: * Education: Bachelor's Degree in a biomedical, biological or regulatory science field * Required Experience: 8+ years of related experience * Required Technical Skills: Understand Current Good Clinical Practice (cGCP), Current Good Laboratory Practices (cGLP) and Current Good Manufacturing Practices (cGMP), to apply knowledge of FDA requirements and procedures, especially Title 21 Code of Federal Regulations (CFR) regulations concerning IND protocols; Capable of applying knowledge in the area of DoD acquisition, force health protection, and clinical/FDA regulatory product development; Proficient with Microsoft (MS) Office 365 suite of applications, to include; MS Outlook, MS PowerPoint, MS Excel, MS Word, MS One Drive, MS TEAMS, and MS OneNote (SharePoint at an intermediate level) * Security Clearance Level: No security clearance needed, however must be able to obtain a NACI (T1) * Required Skills and Abilities: Excellent verbal and written communication skills; Be proactive and work both independently and in a team environment * Preferred Experience: Medical product management experience, including knowledge of applicable FDA regulations and experience with FDA submissions * Location: Hybrid (on-site 3 days a week at Ft. Detrick, MD) * Travel: Willingness to travel CONUS and OCONUS * US Citizenship Required GDIT IS YOUR PLACE * 401K with company match * Comprehensive health and wellness packages * Internal mobility team dedicated to helping you own your career * Professional growth opportunities including paid education and certifications * Cutting-edge technology you can learn from * Rest and recharge with paid vacation and holidays #GDITPriority #GDITFedHealth The likely salary range for this position is $96,034 - $123,050. This is not, however, a guarantee of compensation or salary. Rather, salary will be set based on experience, geographic location and possibly contractual requirements and could fall outside of this range. Scheduled Weekly Hours: 40 Travel Required: None Telecommuting Options: Hybrid Work Location: USA MD Fort Detrick Additional Work Locations: Total Rewards at GDIT: Our benefits package for all US-based employees includes a variety of medical plan options, some with Health Savings Accounts, dental plan options, a vision plan, and a 401(k) plan offering the ability to contribute both pre and post-tax dollars up to the IRS annual limits and receive a company match. To encourage work/life balance, GDIT offers employees full flex work weeks where possible and a variety of paid time off plans, including vacation, sick and personal time, holidays, paid parental, military, bereavement and jury duty leave. To ensure our employees are able to protect their income, other offerings such as short and long-term disability benefits, life, accidental death and dismemberment, personal accident, critical illness and business travel and accident insurance are provided or available. We regularly review our Total Rewards package to ensure our offerings are competitive and reflect what our employees have told us they value most. We are GDIT. A global technology and professional services company that delivers consulting, technology and mission services to every major agency across the U.S. government, defense and intelligence community. Our 30,000 experts extract the power of technology to create immediate value and deliver solutions at the edge of innovation. We operate across 30 countries worldwide, offering leading capabilities in digital modernization, AI/ML, Cloud, Cyber and application development. Together with our clients, we strive to create a safer, smarter world by harnessing the power of deep expertise and advanced technology. We connect people with the most impactful client missions, creating an unparalleled work experience that allows them to see their impact every day. We create opportunities for our people to lead and learn simultaneously. From securing our nation's most sensitive systems, to enabling digital transformation and cloud adoption, our people are the ones who make change real. Equal Opportunity Employer / Individuals with Disabilities / Protected Veterans