Scientific Affairs Specialist

Kirstin Gardiner

Linked In: https://www.linkedin.com/in/kirstinpromise

435-***-**** — Vancouver, WA — **************@*****.*** Claims Substantiator / Claims Specialist

Experienced in structuring complex scientific data into clear, accessible systems that support regulatory alignment and internal efficiency. Skilled at translating peer-reviewed research into actionable documentation used across departments to streamline workflows and support product integrity. Qualifications

• SOP Development

• Research Database Creation

• Process Optimization

• Regulatory Compliance Insight

• Technical Writing

• Scientific Literature Analysis

• Cross-Department Collaboration

• Data Management Systems

• Claims Substantiation Strategy

• Safety Data Sheet Authoring

• Workflow Efficiency Improvement

• Peer-Reviewed Evidence Synthesis

• Regulatory Document Review

• Scientific Data Organization

Work Experience

Scientific Affairs Specialist Springville, UT (Remote) 2009 – 2025 Modere

• Wrote standard operating procedures to define and organize tasks across all roles in the scientific affairs department, ensuring consistency in daily operations

• Created a searchable database containing over 30,000 peer-reviewed articles to support literature referencing for internal documentation

• Took on additional tasks outside the original job description to cover gaps in departmental needs and improve continuity

• Led coordination of the company’s FAQ process, reducing the average internal response time from six weeks to one week by learning staff preferences and tailored their requests to what suited them best

• Built a categorized ingredient research repository that reduced repeated literature reviews and shortened research preparation time by roughly 30%

• Developed a centralized system to track Safety Data Sheets for finished products, improving accessibility and version control

• Redesigned the layout of the claims substantiation sheet four separate times in response to usability feedback from multiple departments

• Drafted monographs for each finished product using only peer-reviewed literature as the foundation, with references matched to each active ingredient

• Created simplified review sheets that extracted relevant claims data from full monographs, allowing team members to compare product formulas more efficiently

• Oversaw updates to the ingredient documentation system, capturing changes in substantiation evidence and ingredient usage over time

• Used Wercs Elite software to input compositional data and generate Safety Data Sheets for all finished goods in alignment with chemical safety requirements

• Evaluated marketing claims for products by comparing them with available scientific literature and regulatory guidelines issued by FDA, FTC, and international bodies

• Maintained documentation of all changes made to the ingredient paradigm, including the rationale and scientific references for each adjustment

• Collaborated with regulatory and legal teams to ensure that the evidence used for claims substantiation aligned with acceptable thresholds for risk and documentation

Education

Applied Environmental Geoscience Bachelors Weber State University

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