Senior Program Analyst — Regulatory & IND Lead

General Dynamics Information Technology; Frederick (MD); Hybrid; USD 85,000 - 98,000; Full time

Job summary

General Dynamics Information Technology (GDIT) seeks a Senior Program Analyst to support the Defense Health Agency's Force Health Protection Division at Ft. Detrick, MD.

The role leverages regulatory and project management experience to help ensure medical countermeasures and treatments meet DHA requirements. You will provide PM support, assist with EAPs/EUAs for vaccines and antivirals, apply relevant laws and policies, coordinate with FDA and other stakeholders, and develop regulatory

Qualifications

• Bachelor’s degree in a related field or the equivalent combination of education, professional training, or work experience.
• 5+ years of related experience
• Experience supporting regulatory documentation review of IND products

Responsibilities

• Provide project management support to assigned product managers and 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 for force health protection missions.
• Work with the DHA Office of Regulatory Activities (ORA) to develop regulatory documents and ensure IND protocols meet regulatory requirements, including FDA submissions.
• Coordinate and communicate with stakeholders including COCOMs, FDA, industry partners, and other organizations.
• Support meetings, create agendas, track action items, and synthesize information.
• Develop documents and presentation materials, craft audience-tailored messages, review for completeness/correctness/formatting.
• Support multiple efforts and effectively prioritize requirements impacting the product portfolio.
• Assist with programmatic and technical document review and market research.
• Participates in special projects as required.

Skills

Communication

Proactive Planning

Regulatory Policies

Education

Bachelor’s degree

Tools

MS Office

TEAMS

Job description

General Dynamics Information Technology (GDIT) seeks a Senior Program Analyst to support the Defense Health Agency's Force Health Protection Division at Ft. Detrick, MD.

The role leverages regulatory and project management experience to help ensure medical countermeasures and treatments meet DHA requirements. You will provide PM support, assist with EAPs/EUAs for vaccines and antivirals, apply relevant laws and policies, coordinate with FDA and other stakeholders, and develop regulatory