Req ID: RQ226284
Type of Requisition: Regular
Clearance Level Must Be Able to Obtain: None
Public Trust/Other Required: NACI (T1)
Job Family: Program Delivery and Execution
Skills:
Communication,Proactive Planning,Regulatory Policies
Experience:
5 + years of related experience
US Citizenship Required:
Yes
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
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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.
Total Rewards at GDIT:
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 offers employees full flex work weeks where possible and a variety of paid time off plans, including vacation, sick and personal time, holidays, paid parental, military, bereavement and jury duty leave. To ensure our employees are able to protect their income, other offerings such as short and long-term disability benefits, life, accidental death and dismemberment, personal accident, critical illness and business travel and accident insurance are provided or available. We regularly review our Total Rewards package to ensure our offerings are competitive and reflect what our employees have told us they value most.
Our Identity Verification Process:
As part of the hiring process, we will ask you to complete an identity verification process that leverages advanced biometrics and artificial intelligence to ensure authenticity and protect against identity fraud. You are expected to be on camera during virtual interviews. We reserve the right to take your picture to verify your identity and prevent fraud. By proceeding, you authorize the collection, processing, and use of your biometric data for identity verification and security purposes.
About Our Work:
We are GDIT. A global technology and professional services company that delivers technology solutions and mission services to every major agency across the U.S. government, defense and intelligence community. Our 26,000 experts extract the power of technology to create immediate value and deliver solutions at the edge of innovation. We operate across 50+ countries worldwide, offering leading mission-ready capabilities in AI, cloud, cyber and software development.
Join our Talent Community to stay up to date on our career opportunities and events at https://gdit.com/tc.
Equal Opportunity Employer / Individuals with Disabilities / Protected Veterans
