Program Analyst Senior

Seize your opportunity to make a personal impact as a Senior Program Analyst supporting the Defense Health Agency (DHA) Force Health Protection Division rick, 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.

Job Qualifications:

Communication, Proactive Planning, Regulatory Policies

Clearance Level Must Currently Possess:
None

Clearance Level Must Be Able To Obtain:
None

Public Trust/Other

Required:

NACI (T1)

Certifications:

None

• 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.

• 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 rick, MD)
• Travel:
  Less than 10%
• US Citizenship Required

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

The likely salary range for this position is $85,093 - $97,857. This is not, however, a guarantee of compensation or salary. Rather, salary will be set based on experience, geographic location and possibly contractual requirements and could fall outside of this range.

Scheduled Weekly

Hours:

40

Our benefits package for all US-based employees includes a variety of medical plan options, some with Health Savings Accounts, dental plan options, a vision plan, and a 401(k) plan offering the ability to contribute both pre and post-tax dollars up to the IRS annual limits and receive a company match. To encourage work/life balance, GDIT…