Program Analyst Senior

General Dynamics Information Technology • Fort Detrick, MD

15h • $85,093 - $97,857 • Hybrid

About The Position

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.

Requirements

• Bachelor’s degree in a related field or the 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.
• Excellent communications, writing, organizational and project management skills.
• Highly proactive self-starter to work both independently and in a team environment.
• US Citizenship Required

Nice To Haves

• Medical product management experience, including knowledge of applicable FDA regulations and experience with FDA submissions.

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 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.

Benefits

• Comprehensive benefits and wellness packages
• 401K with company match
• Competitive pay
• Paid time off
• Full flex work weeks where possible
• Variety of paid time off plans, including vacation, sick and personal time, holidays, paid parental, military, bereavement and jury duty leave.
• Short and long-term disability benefits
• Life, accidental death and dismemberment, personal accident, critical illness and business travel and accident insurance

What This Job Offers

• Job Type: Full-time
• Career Level: Senior