Program Analyst Senior

GDIT is seeking a Senior Program Analyst to support the Defense Health Agency (DHA) Force Health Protection Division at Ft. Detrick, MD. This role offers the opportunity to make meaningful contributions to challenging projects in a rewarding career.

About the role

Utilize your regulatory and project management experience to ensure medical countermeasures and treatments align with DHA requirements. This position requires U.S. citizenship and the ability to obtain a T1 Public Trust (NACI).

Responsibilities

• 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 major issues and goals 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, including supporting FDA submissions.
• Coordinate and communicate with multiple stakeholders, including COCOMs, FDA, industry partners, and other organizations using effective interpersonal and communication skills.
• Support meetings by creating agendas, identifying and following up on action items, tracking taskers, taking minutes, and synthesizing information.
• Develop documents and presentation materials, craft audience-tailored messages, and review for completeness, correctness, and formatting.
• Support numerous efforts, effectively prioritize and multi-task requirements impacting the product portfolio.
• Assist with programmatic and technical document review and market research.
• Participate in special projects as required.

Requirements

• Bachelor’s degree in a related field or equivalent combination of education, professional training, or work experience.
• 5+ years of related experience.
• Intermediate experience with Microsoft Office Suite (Word, PowerPoint, Project, Excel, Outlook, and TEAMS).
• Prior experience supporting regulatory documentation review of IND products.
• U.S. citizenship required.

Preferred Qualifications

• Medical product management experience, including knowledge of applicable FDA regulations.
• Experience with FDA submissions.
• Excellent communication, writing, organizational, and project management skills.
• Highly proactive self-starter able to work both independently and in a team environment.

Schedule

• Hybrid work schedule (on-site 3 days a week at Ft. Detrick, MD).
• Scheduled weekly hours: 40.
• Travel required: Less than 10%.

Pay

The likely salary range for this position is $85,093 - $97,857. Salary will be set based on experience, geographic location, and possibly contractual requirements.

Benefits

• Comprehensive medical, dental, and vision plan options, some with Health Savings Accounts.
• 401(k) plan with company match (pre- and post-tax contributions up to IRS annual limits).
• Paid time off, including vacation, sick, personal time, holidays, parental leave, military leave, bereavement, and jury duty leave.
• Short- and long-term disability benefits, life insurance, accidental death and dismemberment, personal accident, critical illness, and business travel and accident insurance.
• Flexible work weeks where possible to encourage work/life balance.