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Description: Collaborate with various departments to strategize, coordinate, execute, and oversee clinical trials and testing activities. Develop protocols and prepare final reports for clinical trials. Draft, review, and update standard operating procedures within the regulatory department. Stay informed and up-to-date on regulatory standards including 9 CFR, 21 CFR, the Animal Welfare Act, VS Memos, and other relevant regulations. Engage with government agencies such as USDA and FDA, as well as current or potential business partners, regarding regulatory matters. Communicate with distribution partners and foreign government agencies to facilitate product registration or maintenance of product registration. Support the product licensure process for new products. Handle applications for and renewal of permits for receiving regulated materials and for exporting to other countries. Process complaints according to FDA and USDA regulations and maintain records of adverse events. Prepare annual periodic Drug Experience Reports as required. Participate in the Institutional Biosafety Committee and Institutional Animal Care and Use Committee. Conduct training sessions for Regulatory and Animal Care staff. Assess the health status of laboratory animals and provide medical care as needed. Offer Quality Assurance support as necessary. Perform additional assigned duties as required.Skills:Animal science, Veterinary, Animal research, Veterinarian Science, clinical trial, Clinical Research, Regulatory, Animal Care, USDA, FDATop Skills Details:Animal science,Veterinary,Animal research,Veterinarian ScienceAdditional Skills & Qualifications: Veterinary Medicine (DVM) degree required. An MS/PhD in the Biological Sciences is beneficial but not mandatory. Must have a DVM license for the state of Iowa. Preferably, 2 years of clinical practice experience. Experience and/or keen interest in regulatory support, technical writing, research and development, and clinical trials are advantageous.Experience Level:Intermediate LevelAbout Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
