Clinical Studies Veterinarian

Clinical Studies Veterinarian-The Clinical Studies Veterinarian will execute clinical projects (pilot and pivotal animal studies, analysis of technical feasibility, literature analysis and other technical tasks) to support US and global Product Development projects. The clinical projects will lead to the registration and/or commercial launch of new products, maintenance of existing products and or technical support for the establishment and maintenance of the pipeline portfolio.

The Clinical Studies Veterinarian will understand and acquire advanced knowledge of the regulatory framework for clinical and development activities (veterinary GDP, GLP and GCP regulations) in the US, Canada, Europe and Japan and will develop clinical development plans through working with the Product Development Managers, the Clinic Team and external partners.

The Clinical Studies Veterinarian will author protocols, statistical analysis plans, monitoring plans, study support documents, change control documentation, clinical training documents and basic regulatory documents (NCIs, meeting slides, technical section components).

The Clinical Studies Veterinarian will coordinate CRO-based activities to complete scientific tasks, will author final study reports, will compile all quality reviewed study documents and assemble submission ready components of dossiers or product development files.

The Clinical Studies Veterinarian will review protocols, reports and scientific documents generated by other members of the clinical team or research partners.

Qualifications: The successful candidate will have advanced knowledge of the regulatory framework for clinical and development activities (veterinary GDP, GLP and GCP regulations) in the US, Canada, Europe and Japan, have working knowledge of Good Clinical Practices, Good Laboratory Practices, Good Documentation Practices and the Code of Federal Regulations relevant to FDA/CVM and EPA, advanced scientific writing competency and have knowledge of regulations regarding the use of animals in research. Other requirements include a thorough knowledge of and competency in the current standards of veterinary clinical practice, working knowledge of Microsoft Word, Excel, PowerPoint, Project and electronic data capture. A DVM/VMD or equivalent training and experience is required with 5+ years of experience in veterinary practice and 3-4+ years of experience in the regulated animal health industry Ability to travel up to 30% is required. Project management training or certification is preferred.

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