Seize your opportunity to make a personal impact as a Senior Program Analyst supporting the Defense Health Agency (DHA) Force Health Protection Division at Ft. Detrick, MD. GDIT is your place to make meaningful contributions to challenging projects and grow a rewarding career. Our work depends on a Senior Program Analyst joining our team and utilizing their regulatory and project management experience to ensure the medical countermeasures and treatments following DHA requirements. HOW YOU WILL MAKE AN IMPACT:Provide project management support to assigned product managers and Investigation New Drug (IND) medical products.Assist the product manager in preparing Expanded Access Programs (EAPs)/Emergency Use Authorizations (EUAs) for vaccines, products, and antivirals.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. Coordinate and communicate with multiple stakeholders, to include the COCOMs, FDA, industry partners, and other organizations through the use of effective interpersonal and communication skills.Support meetings, create agendas, identify and follow-up on action items, keep up with taskers, take minutes and synthesize the information.Develop documents and presentation materials, craft messages tailored to an audience, review for completeness/correctness/formatting.Support numerous efforts and effectively prioritize and multi-task requirements that have a direct impact on the product portfolio.Assist with programmatic and technical document review and market research.Participates in special projects as required. WHAT YOU’LL NEED TO SUCCEED:Education: Bachelor’s degree in a related field or the equivalent combination of education, professional training, or work experience.Required Experience: 5+ years of related experienceRequired Technical Skills: Intermediate experience with Microsoft Office Suite (Word, PowerPoint, Project, Excel, Outlook, and TEAMS);
Prior experience supporting regulatory documentation review of IND products.Preferred Technical Skills and Experience: Medical product management experience, including knowledge of applicable FDA regulations and experience with FDA submissions.Security Clearance Level: Not applicable, however must be clearable for a T1 Public TrustAttributes for Success: Excellent communications, writing, organizational and project management skills. Highly proactive self-starter to work both independently and in a team environment. Location: Hybrid (on-site 3 days a week at Ft. Detrick, MD)Travel: Less than 10%US Citizenship Required GDIT IS YOUR PLACE: At GDIT, the mission is our purpose, and our people are at the center of everything we do.Growth: AI-powered career tool that identifies career steps and learning opportunitiesSupport: An internal mobility team focused on helping you achieve your career goalsRewards: Comprehensive benefits and wellness packages, 401K with company match, and competitive pay and paid time offCommunity: Award-winning culture of innovation and a military-friendly workplace #GDITFedHealthJobs #MilitaryHealthGDITJobs
Prior experience supporting regulatory documentation review of IND products.Preferred Technical Skills and Experience: Medical product management experience, including knowledge of applicable FDA regulations and experience with FDA submissions.Security Clearance Level: Not applicable, however must be clearable for a T1 Public TrustAttributes for Success: Excellent communications, writing, organizational and project management skills. Highly proactive self-starter to work both independently and in a team environment. Location: Hybrid (on-site 3 days a week at Ft. Detrick, MD)Travel: Less than 10%US Citizenship Required GDIT IS YOUR PLACE: At GDIT, the mission is our purpose, and our people are at the center of everything we do.Growth: AI-powered career tool that identifies career steps and learning opportunitiesSupport: An internal mobility team focused on helping you achieve your career goalsRewards: Comprehensive benefits and wellness packages, 401K with company match, and competitive pay and paid time offCommunity: Award-winning culture of innovation and a military-friendly workplace #GDITFedHealthJobs #MilitaryHealthGDITJobs