Senior Program Management Analyst (Science Field)

General Dynamics Information Technology; Frederick (MD); Hybrid; USD 96,000 - 124,000; Full time

Job summary

An established industry player seeks a Senior Program Management Analyst to support the Defense Health Agency. This role offers the chance to make a significant impact on medical countermeasures and treatments while ensuring compliance with DoD requirements. You will manage IND protocols, collaborate with regulatory bodies, and lead project teams in a hybrid work environment. With a competitive salary and comprehensive benefits, this position provides an opportunity for professional growth and meaningful contributions to national health initiatives.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Paid Time Off

Qualifications

• 8+ years of related experience in program management and regulatory science.
• Proficiency in FDA requirements and IND protocols.

Responsibilities

• Provide program/project management support for IND medical products.
• Collaborate with DHA to ensure compliance with FDA requirements.

Skills

Clinical Protocol

FDA Regulations

Protocol Management

Education

Bachelor’s Degree in biomedical, biological, or regulatory science

Tools

MS Office 365

SharePoint

Job description

**Req ID:** RQ198657

**Type of Requisition:** Regular

**Clearance Level Must Be Able to Obtain:** None

**Public Trust/Other Required:** NACI (T1)

**Job Family:** Program Management

**Skills:**

• Clinical Protocol
• FDA Regulations
• Protocol Management

**Experience:**

8+ years of related experience

**US Citizenship Required:** Yes

Job Description

Seize your opportunity to make a personal impact as a Senior Program Management Analyst (Science Field) supporting Defense Health Agency (DHA) Operational Medicine (OPMED). GDIT is your place to make meaningful contributions to challenging projects and grow a rewarding career.

Our work depends on a Senior Program Management Analyst utilizing their experience and science background to ensure medical countermeasures and treatments follow DoD requirements and meet acquisition timelines to support the Warfighter.

HOW YOU WILL MAKE AN IMPACT:

• Provide program/project management support to assigned IND medical products.
• Apply laws, regulations, policies, procedures, and work processes to force health protection missions.
• Collaborate with the DHA Office of Regulatory Activities (ORA) to develop regulatory documents and ensure IND protocols meet FDA requirements.
• Interact with SMEs and IRBs to gain IRB approval.
• Manage storage, protocols, and oversee product release for FHP IND products.
• Coordinate with stakeholders to analyze complex information and manage therapeutics, diagnostics, and clinical protocols.
• Participate in IPTs and working groups, lead meetings, develop reports, and assist with deliverables.
• Prioritize and multi-task on portfolio-impacting requirements.
• Communicate effectively across personnel levels.
• Participate in special projects as needed.

WHAT YOU NEED TO SUCCEED:

• Education: Bachelor’s Degree in biomedical, biological, or regulatory science.
• Experience: 8+ years related experience.
• Technical Skills: Knowledge of cGCP, cGLP, cGMP, FDA requirements, and CFR regulations concerning IND protocols; familiarity with DoD acquisition and force health protection; proficiency in MS Office 365 suite, including SharePoint at an intermediate level.
• Security Clearance: No clearance required, but must obtain NACI (T1).
• Skills & Abilities: Excellent communication skills, proactive, able to work independently and in teams.
• Preferred Experience: Medical product management, FDA regulations, and submissions.
• Location: Hybrid (on-site 3 days at Ft. Detrick, MD).
• Travel: Willing to travel within CONUS and OCONUS.

**GDIT is your place** for growth, benefits, and impactful work. Compensation ranges from $96,034 to $123,050, based on experience and location. Our benefits include medical, dental, vision, 401(k), paid time off, and more. Join us in creating a safer, smarter world.