Scientific Subject Matter Expert I

About the role

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.

Responsibilities

• 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)
• 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

Qualifications

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)

Benefits

We offer a competitive compensation package 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.

Pay

Competitive compensation is offered based on experience and qualifications.

Schedule

The schedule is flexible and tailored to meet the needs of the individual and the organization.