Type of Requisition:

Clearance Level Must Currently Possess:

Clearance Level Must Be Able to Obtain:

Public Trust/Other Required:

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Skills:

Certifications:

Experience:

US Citizenship Required:

Job Description:

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 experience
• Required 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 Trust
• Attributes 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 opportunities
• Support: An internal mobility team focused on helping you achieve your career goals
• Rewards: Comprehensive benefits and wellness packages, 401K with company match, and competitive pay and paid time off
• Community: Award-winning culture of innovation and a military-friendly workplace

#GDITFedHealthJobs  

#MilitaryHealthGDITJobs 

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