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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in conducting and monitoring in vivo preclinical safety studies for veterinary pharmaceuticals, ensuring compliance with Good Laboratory Practices and regulatory requirements. Proficient in generating submission-ready reports and packages for global health authorities, with strong communication and organizational skills.
Highest-signal resume keywords
In Vivo Preclinical Safety StudiesGood Laboratory Practices (GLPs)Regulatory Submission PreparationScientific WritingData Analysis
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Veterinary SciencesToxicologyPharmacologyBioanalytical TechniquesFlow CytometryImmunohistochemistry (IHC)Tissue Culture TechniquesExperimentationClinical JudgmentResearch Proposal Development
Soft Skills
Excellent Verbal CommunicationExcellent Written CommunicationAttention to DetailTeam PlayerInterpersonal SkillsMultitaskingAdaptability
Tools & Technologies
Microsoft WordMicrosoft ExcelMicrosoft PowerPointSharePointAutomated Liquid Handling Systems
Industry Keywords
VICH/GLP21 CFR 58OECDCompanion Animal PharmaceuticalsCRO Experience
About the role
Key responsibilities & impact- Participate as a member of multiple study teams under the supervision or leadership of assigned study leads in Preclinical Development-US
- Assist in designing, coordinating, monitoring, and reporting in vivo safety studies for companion animals and/or residue studies for livestock veterinary small-molecule pharmaceuticals
- Support studies intended to obtain regulatory approval from global health authorities, especially the US FDA
- Conduct studies in accordance with Good Laboratory Practice regulations and applicable regulatory guidance
- Travel to CROs to observe critical study phases
- Perform quality control review
- Generate and prepare raw data/XML files
- Generate submission-ready packages for global and US health authorities
- Assist study leads in meeting study timelines and successful study outcomes
- Lead generation of raw data packages and submission-ready reports/packages
- Participate in protocol and data-capture-form creation
- Help identify CROs and prepare study contracts
- Participate in pre-study meetings, protocol review/training, and study monitoring visits
- Collect, review, and monitor study documentation
- Prepare monitoring visit reports
- Communicate regularly with study leads and track study-related activities
- Review raw data, study documentation, phase reports, and final reports for completeness and data integrity
- Organize and assemble global and US-only submissions for Preclinical Development
- Assist in reviewing and finalizing study reports
- Prepare study packages for regulatory submission
- Transfer study packages to archivists or document depositors
Requirements
What you’ll need- Bachelor of Science with at least four (4) years of experience in veterinary sciences, toxicology/pharmacology, pharmacokinetics, biology, chemistry, biochemistry, or equivalent
- Recent (within the last 3 years) experience conducting and/or monitoring in vivo preclinical safety studies supporting registration of veterinary/companion animal pharmaceuticals in an industrial setting or CRO
- Experience preparing and/or obtaining solid scientific reports from CROs
- Experience with Good Laboratory Practices (GLPs)
- Excellent verbal and written communication skills
- Good attention to detail
- Team-player with strong interpersonal skills
- Ability to multitask, manage competing priorities, deliver work product within established timelines, and adapt to rapidly shifting priorities
- Knowledge of standard computer software applications, including Microsoft Word, Excel, PowerPoint, and SharePoint
- Familiarity with applicable departmental SOPs, regulations, and guidelines, including VICH/GLP, 21 CFR 58, or OECD
- Automated Liquid Handling Systems
- Bioanalytical Method Development
- Bioanalytical Techniques
- Clinical Judgment
- Data Analysis
- Experimentation
- Flow Cytometry
- Immunohistochemistry (IHC)
- Research Proposal Development
- Scientific Writing
- Tissue Culture Techniques
- US and Puerto Rico residency
- No visa sponsorship available
Benefits
Comp & perks- Annual bonus and long-term incentive, if applicable
- Medical, dental, vision healthcare and other insurance benefits for employee and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate and sick days
- Hybrid work arrangement