Our client is seeking a dedicated and knowledgeable R&D Specialist to join their team. This role offers the unique opportunity to contribute to a global mission of improving animal health, which in turn impacts the health of our planet.
As an R&D Specialist, your primary role will involve planning and executing clinical projects to support both US and global product development projects. You will be responsible for understanding and adhering to the animal pharmaceutical regulatory framework for clinical and development activities. Your role will also involve selecting appropriate subcontractors, authoring protocols, coordinating CRO-based activities, facilitating cross-functional collaboration for drug development, and representing the Clinical function within various teams. Your contributions will directly impact the clinical development of new products while ensuring their effectiveness and safety.
- Plan, execute, and report clinical studies for animal drug development
- Ensure compliance with veterinary GDP, GLP and GCP regulations in the USA
- Select appropriate subcontractors (CROs) to manage studies
- Author protocols, study support documents, and regulatory documents
- Coordinate CRO-based activities to complete scientific tasks in a timely manner
- Facilitate cross-functional collaboration for drug development
- Represent the Clinical function within the US Clinical Team and Corporate R&D project teams
The ideal candidate for this R&D Specialist role brings a wealth of experience in veterinary practice as well as in the Regulated Pharmaceutical Animal Health Industry. You possess working knowledge of Good Clinical Practices, Good Laboratory Practices, Good Documentation Practices, and the Code of Federal Regulations relevant to FDA/CVM and EPA. Your advanced scientific writing skills will be crucial in authoring protocols and regulatory documents. Your ability to communicate effectively, influence others, demonstrate adaptability, self-development skills, problem-solving abilities, organisational skills, drive for results orientation will make you a valuable addition to our team.
- 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
- Thorough knowledge of current standards of veterinary clinical practice
- Fluency in English
- Ability to communicate effectively and influence others
- Demonstrated adaptability and self-development skills