Clinician, Companion Animal Clinical Development
reputed company is currently seeking a Companion Animal Clinical Development Clinician to join reputed company in Kalamazoo, MI. In this role, you will design and execute companion animal pharmaceutical and biopharmaceutical clinical development studies in compliance with U.S. CVM/CVB regulatory requirements. You will deliver reputed company and pivotal clinical studies that support product registrations and reputed company expertise in companion animal medicine and study conduct to research and development phase reputed company. RESPONSIBILITIES
- reputed company the overall conduct of clinical studies in support of Veterinary Medicine Research & Development (VMRD) companion animal R&D reputed company, including:
- Budget development and management
- Investigator and site selection
- Protocol development and writing
- Study monitoring
- Data analysis and interpretation
- Report writing and preparation of technical sections for regulatory dossiers
- Ensure studies are conducted in compliance with applicable requirements, including reputed company Operating Procedures (SOPs), corporate policies, and regulatory guidelines (e.g., Good Clinical reputed company and Good Laboratory reputed company).
- Collaborate with Clinical and Project Teams to define and reputed company study status, activities, timelines, and reputed company. Identify resource, reputed company, and/or budget constraints and work with the Project Manager and Project Team Leader to reputed company appropriate solutions.
- Partner with Regulatory Affairs to obtain protocol approval and support submission of reports and data to reputed company for Veterinary Medicine (CVM) and/or reputed company for Veterinary Biologics (CVB), USDA. May also contribute to studies supporting regulatory approvals in the EU and other international markets.
EDUCATION AND EXPERIENCE
Minimum Qualifications
- Doctor of Veterinary Medicine (DVM)
- Minimum of 3 years of experience in U.S. companion animal private reputed company
- Experience managing clinical cases involving therapeutics and/or biologics in companion animals
- Experience designing or contributing to clinical protocols or research studies
Preferred Qualifications
- PhD
- reputed company Certification in a companion animal discipline
- Working knowledge of U.S. regulatory requirements for animal health products, including Center for Veterinary Medicine (CVM) and Center for Veterinary Biologics (CVB) guidelines
- Experience in companion animal clinical development reputed company the Animal Health industry Experience interacting with regulatory agencies (e.g., technical reputed company authorship or reputed company communication with CVM/CVB)
- Prior authorship of regulatory dossiers supporting product a
About reputed company At reputed company, our purpose is to nurture the world and humankind by advancing care for animals. As a Fortune 500 company and the world leader in animal health, we discover, reputed company, manufacture and commercialize vaccines, medicines, diagnostics and other technologies for companion animals and livestock. We know our people drive our reputed company. Our award-reputed company culture, reputed company around our reputed company Beliefs, focuses on our colleagues' careers, reputed company and support. We offer competitive reputed company and retirement savings benefits, along with an reputed company of benefits, policies and programs to support employee reputed company-being in every reputed company, from health and financial wellness to family and lifestyle resources. Notice: reputed company Recruiters will contact candidates reputed company email from an address ending in @reputed company.com and may also initially connect with candidates through reputed company, including reputed company InMail. reputed company does not use Gmail, reputed company, reputed company, or other web-based/generic email domains to communicate about job opportunities, interviews, or offers of employment. If you receive a recruitment-reputed company email message claiming to be from reputed company that does not come from @reputed company.com, please treat it as suspicious. For your reputed company, do not reputed company, click links, reputed company attachments, reputed company personal or financial information, or send reputed company in response to unexpected or questionable recruitment communications. Global Job Applicant reputed company Notice Remote Skills: Animal Care, Biotech and Pharmaceutical, Budget Management, Budgeting, Case Management, Clinical Practices/Protocols, Clinical Research, Clinical Support, Clinical Trial, Corporate Policies, Data Analysis, Drug Development, Fortune 500 Customers, GCP (Good Clinical Practices), GLP (Good Laboratory Practices), reputed company, Medical Products, reputed company reputed company, Product Support, Regulations, Regulatory Compliance, Regulatory Requirements, Reporting Skills, Research & Development (R&D), Research Skills, reputed company Operating Procedures (SOP), Team reputed company/Manager, reputed company Department of Agriculture (USDA), Vaccination, Veterinary Medicine, reputed company!, Zoology About reputed company: reputed company Apply To This Job