Scientific Subject Matter Expert II

Koniag IT Systems, LLC
, a Koniag Government Services company, is seeking a Scientific Subject Matter Expert II to support KITS and our government customer in Silver Spring, MD. This position requires the candidate to be able to obtain a Public Trust. This position is for a Future New Business Opportunity.

We offer competitive compensation and an extraordinary benefits package including health, dental, and vision insurance, 401(k) with company matching, flexible spending accounts, paid holidays, three weeks paid time off, and more.

Koniag IT Systems is seeking an exceptional Scientific Subject Matter Expert II to provide specialized expertise in researching and analyzing complex scientific and medical information. This position requires an advanced degree in a relevant field and a proven track record of excellence in abstracting data from regulatory applications and scientific reports.

The Subject Scientific Subject Matter Expert II will play a pivotal role in our operations, leveraging their deep subject matter expertise to conduct comprehensive research, analyze intricate scientific data, and communicate findings to FDA staff and stakeholders. The primary responsibilities of this role include:

• Perform in-depth research and analysis of complex scientific and medical information from regulatory applications, reports, and other authoritative sources
• Abstract and synthesize key data, insights, and findings from scientific documentation and studies
• Lead projects and initiatives focused on scientific research, data analysis, and report generation
• Draft detailed reports and presentations, effectively communicating technical information to FDA staff and subject matter experts
• Serve as a subject matter authority, providing guidance and expertise to cross‑functional teams
• Collaborate with stakeholders to ensure accurate interpretation and effective dissemination of scientific findings

Education: Advanced degree (master’s degree or higher) in a medical, life sciences, or closely related field.

• Extensive expertise in researching and abstracting complex scientific and medical information from regulatory applications and scientific reports
• Experience leading projects, drafting reports, and presenting information to FDA staff or similar audiences (preferred)
• Exceptional research and analytical abilities, with a proven track record of synthesizing complex scientific and medical data
• Superb written and verbal communication skills, with the ability to convey technical information clearly and effectively
• Strong project management and leadership capabilities
• Proficiency in relevant scientific software, databases, and research tools
• Meticulous attention to detail and commitment to accuracy
• Ability to collaborate effectively with cross‑functional teams and stakeholders
• Ability to obtain a Public Trust

• Doctoral degree in a relevant field (e.g., life sciences, medical sciences, pharmacology)
• Experience in a regulated industry or government environment, with familiarity of FDA regulations and guidelines
• Expertise in specific scientific or medical domains such as biotechnology, clinical research, drug development
• Certifications or specialized training in areas such as medical writing, regulatory affairs, or scientific communication
• Strong presentation and public speaking abilities

The company is an equal opportunity employer. The company shall not discriminate against any employee or applicant because of race, color, religion, creed, sex, sexual orientation, gender, or gender identity (except where gender is a bona fide occupational qualification), national origin, age, disability, military/veteran status, marital status, genetic information, or any other factor protected by law. We are committed to equal employment opportunity in all decisions related to employment, promotion, wages, benefits and all other privileges, terms, and conditions of employment.

Equal Opportunity Employer/Veterans/Disabled. Shareholder Preference in accordance with Public Law 88‑352.