Scientific Subject Matter Expert II

The company•Silver Spring, MD

About The Position

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, 401K 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. Essential Functions, Responsibilities & Duties may include, but are not limited to: 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:

Requirements

Education: Advanced degree (master’s degree or higher) in a medical, life sciences, or closely related field
Work Experience, Knowledge, Skills & Abilities: 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

Nice To Haves

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 (e.g., 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

Responsibilities

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