What are the responsibilities and job description for the Field and Controlled Environments Study Director position at Corteva Agriscience?
Who are we, and what do we do?
At Corteva Agriscience, you will help us grow what’s next. No matter your role, you will be part of a team that is building the future of agriculture – leading breakthroughs in the innovation and application of science and technology that will better the lives of people all over the world and fuel the progress of humankind.
Corteva Agriscience is currently seeking a Study Director to join the Field & Controlled Environments Team within Regulatory Science. The position supports the successful registration of Corteva biotech products through leading regulatory field and controlled environments studies following Environmental Protection Agency (EPA) Good Laboratory Practices (GLPs).
Responsibilities – What You Will do:
- Plan and oversee regulatory GLP field and controlled environment studies (run by 3rd parties) to support global seed trait submissions. This includes studies conducted in US, Canada, Brazil, and other countries, as needed.
- Interact with field contract research organizations (CRO) from protocol creation to report completion and develop detailed records of the progression of the study.
- Monitor progression of studies and ensure data collection is completed in time. Includes setting expectations with trial manager, addressing questions about the studies and, occasionally, traveling to testing sites.
- Collaborate with internal regulatory leaders and team members to ensure that studies meet product submission requirements and ensure that study completion timelines align with regulatory submission timelines.
- Review study reports and relevant sections of regulatory submission dossiers and assist team members and subject matter experts with answering questions from regulatory agency reviewers.
- Build and maintain knowledge and understanding of country specific data requirements for regulatory submissions to enable global approvals of Corteva's biotechnology seed traits.
- Support project subject matter expert by providing study information timely.
What Skills You Need:
- Bachelor's degree or MS in agronomy, plant science, biological science, or related field is required.
- Proven experience running field and controlled environments studies under GLP is required.
- Experience with document management across databases, data archiving and scientific writing.
- Proficiency with Microsoft Office, Smartsheet, Spotfire software is preferred.
- Excellent detail-oriented organizational and oral and written communication skills.
- Continuous improvement and process efficiency mindset and attention to detail.
- Ability to work in a cross functional team and address the needs of multiple stakeholders in Regulatory Sciences, Regulatory Affairs, Stewardship and Quality Assurance.
- Work/Visa Sponsorship not offered for this role.
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- Numerous development opportunities offered to build your skills
- Be part of a company with a higher purpose and contribute to making the world a better place
- Health benefits for you and your family on your first day of employment
- Four weeks of paid time off and two weeks of well-being pay per year, plus paid holidays
- Excellent parental leave which includes a minimum of 16 weeks for mother and father
- Future planning with our competitive retirement savings plan and tuition reimbursement program
- Learn more about our total rewards package here –Corteva Benefits
- Check out life at Corteva! www.linkedin.com/company/corteva/life
Are you a good match? Apply today! We seek applicants from all backgrounds to ensure we get the best, most creative talent on our team.
