Management Analyst – SME
Dynanet Corporation
full-time
Posted on:
Location: 🇺🇸 United States
Visit company websiteJob Level
JuniorMid-Level
About the role
- Guides the implementation of curated toxicology data from validated and regulatory-accepted test guidelines into the CAMERA system
- Serves as liaison between scientific stakeholders and IT developers to translate regulatory science requirements into technical specifications
- Reviews and validates toxicological data for accuracy, consistency, and regulatory compliance prior to system integration
- Contributes to the development of standardized vocabularies, metadata structures, and ontologies to support regulatory application of NAMs
- Provides expertise in the scientific review of New Approach Methodologies (NAMs), including applicability and relevance to U.S. and international regulatory frameworks
- Prepares technical reports, analyses, and briefing materials to inform decision-makers, program managers, and external stakeholders
- Recommends process improvements to enhance data quality, interoperability, and system usability in support of regulatory submissions
- Respond to team member and client requests via email, MS teams, or other communication means during core business hours
Requirements
- Demonstrated knowledge of U.S. and international regulatory testing guidelines (e.g., OECD, EPA, FDA)
- Familiarity with alternative test methods, NAMs, and their validation/qualification processes
- Ability to analyze, interpret, and apply scientific data in regulatory contexts
- Strong communication skills to effectively convey technical content to scientific and non-scientific audiences
- Master’s degree or higher in toxicology, pharmacology, regulatory science, or related biological/health sciences
- Minimum of 2 years of research or professional experience in regulatory toxicology
- Ability to interact in a professional and collaborative manner with fellow Dynanet Teammates and the clients, and business partners
- Highly organized with an ability to prioritize, balance, and effectively advance multiple competing priorities
- Excellent judgment and creative problem-solving skills
- Respond to team member and client requests via email, MS teams, or other communication means during core business hours