Scientific Subject Matter Expert I

Koniag IT Systems, LLC, a Koniag Government Services company, is seeking a Scientific Subject Matter Expert I 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 a Scientific Subject Matter Expert I to support our data abstraction and quality control processes for regulatory applications and scientific reports. This position requires a bachelor's degree in a life sciences field and relevant experience in the medical, life sciences, or records information management domains.

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

The Scientific Subject Matter Expert I will play a vital role in our operations, leveraging their subject matter expertise to abstract data from regulatory applications and complex scientific reports accurately. The primary responsibilities of this role include:

Abstract data from regulatory applications and scientific reports, ensuring accuracy and completeness

Utilize FDA-provided Oracle or Access databases, or other computer systems, for data input as required

Perform data validation and quality control functions to maintain data integrity

Support cross-functional teams and stakeholders by providing guidance and subject matter expertise

Collaborate with stakeholders to ensure adherence to data abstraction and quality control processes

Contribute to projects and initiatives related to scientific data management and analysis

Requirements

Education:

Bachelor's degree in a life sciences field (e.g., biology, biochemistry, pharmacology, or related discipline)

Work Experience, Knowledge, Skills & Abilities:

Minimum of 3 years of experience in the medical, life sciences, or records information management field

Ability to abstract data accurately from regulatory applications and complex scientific reports

Proficiency in using databases (e.g., Oracle, Access) and computer systems for data input and management

Strong data validation and quality control skills

Excellent attention to detail and commitment to data accuracy

Solid understanding of scientific and medical terminology and concepts

Effective written and verbal communication skills

Ability to collaborate effectively with cross-functional teams and stakeholders

Ability to obtain a Public Trust

Desired Skills and Competencies:

Experience in a regulated industry or government environment

Familiarity with FDA regulations and guidelines related to scientific data management

Knowledge of electronic document management systems (EDMS) and records management practices

Proficiency in data analysis tools and software (e.g., SAS, R, Python)

Project management experience or certification (e.g., PMP)

Certifications or specialized training in relevant areas (e.g., medical coding, regulatory affairs)

Our Equal Employment Opportunity Policy

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.

The company is dedicated to seeking all qualified applicants. If you require accommodation to navigate or to apply for a position on our website, please contact Heaven Wood via e-mail at or by calling to request accommodation.

Koniag Government Services (KGS) is an Alaska Native Owned corporation supporting the values and traditions of our native communities through an agile employee and corporate culture that delivers Enterprise Solutions, Professional Services and Operational Management to Federal Government Agencies. As a wholly owned subsidiary of Koniag, we apply our proven commercial solutions to a deep knowledge of Defense and Civilian missions to provide forward leaning technical, professional, and operational solutions. KGS enables successful mission outcomes for our customers through solution-oriented business partnerships and a commitment to exceptional service delivery. We ensure long-term success with a continuous improvement approach while balancing the collective interests of our customers, employees, and native communities. For more information, please visit

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