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Description

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 to hire a Submission Specialist, based at our Global Business Center in Johnston, Iowa.

The Submission Specialist role, located within the Regulatory Science - Molecular, Protein, and Field Sciences function, will manage a diverse portfolio of genetically modified (GM) and gene-edited (GE) products, and will collaborate closely with regulatory teams, global registration teams, and study personnel.

What You'll Do:

Technical-Expert Dossier Reviewer:

• Partner with regional regulatory managers and regulatory teams to prioritize dossier review projections and timelines aligned with technical reviewers resourcing capabilities.

• Coordinate dossier reviews for general dossiers, internal country-team dossiers, and third-party dossiers to support out-licensed trait product agreements.

• Prepare the technical review of registration dossiers to assess the accuracy of scientific data, consistency with regulatory requirements, and alignment with global submission strategy for new and existing biotech products.

• Serve as a point of contact to identify and coordinate legal or additional scientific review.

• Facilitate reviewer comments meetings to reconcile outstanding questions and align on recommendations.

Dossier Generation:

• Coordinate and lead the generation and review of dossiers supporting regulatory project teams. This may include drafting scientific content, coordinating scientific reviews, following up on data gaps, driving discussions, and enabling decisions to facilitate critical submissions.

• Leadership and partnership with registration managers and regulatory teams to align on scientific content, global strategy, and timeline is critical to this role.

Broad Regulatory Science Technical Understanding:

• Actively ensure alignment of global data requirements for biotech submissions and maintain an understanding of the status of global submissions, questions asked by regulators, and strategy for responding to questions.

• Support regulatory project teams by developing solutions and maintaining a holistic view of the submissions being made globally including timelines, strategies being leveraged, and types of questions that arise.

• Utilize broad scientific understanding and strong leadership to drive discussions, identify gaps, and collaborate for approach used in future submissions and responses.

• Understand and assist in other components of registration support including redactions, citation support for documents and manuscripts using EndNote software, submission disclosure tracking, agency question and response tracking and analysis, and trait product renewal support.

Continuous Improvement Support:

• Evaluate and implement process improvement and tools to be more efficient in how dossiers are drafted, maintained, and reviewed and tracking global data requirements.

• Identify opportunities to improve planning or further support registration or technical teams.

Qualifications

What Skills You Need:

Education and Experience:

• Preference for master's degree in biology, biochemistry, or related scientific area with 2 years of industry experience in regulatory science, or generating data to support biotech trait development, advancement, or submissions.

• Or bachelor's degree and 5 years of industry related experience in seeds regulatory.

• Preference will be given to candidates that have a strong technical knowledge of a relevant scientific field (e.g., protein characterization, molecular biology) and/or a strong understanding of regulatory submissions and biotech regulatory guidance.

Skills:

• Strong technical writing and communication skills.

• Strong collaboration and creative thinking skills.

• Strong drive to work well both independently and in a team setting.

• Ability to prioritize and manage multiple projects while meeting critical deadlines.

• Excellent verbal and written communication skills.

• Strong problem-solving skills and disposition to adapt to change.

• Excellent organizational and record-keeping skills.

#LI-BB1

Benefits - How We'll Support You:

• 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 (https://careers.corteva.com/2024-us-benefits-guide)

• Check out life at Corteva! www.linkedin.com/company/corteva/life (https://www.linkedin.com/company/corteva/life/3006dde6-2563-4a98-8e94-ee4feba88cff/)

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.

Corteva Agriscience™ is an equal opportunity employer. We are committed to boldly embracing the power of inclusion, diversity, and equity to enrich the lives of our employees and strengthen the performance of our company, while advancing equity in agriculture. Qualified applicants will be considered without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability or any other protected class. Discrimination, harassment and retaliation are inconsistent with our values and will not be tolerated. If you require a reasonable accommodation to search or apply for a position, please visit:

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For US Applicants: See the ‘Equal Employment Opportunity is the Law’ poster

To all recruitment agencies: Corteva does not accept unsolicited third party resumes and is not responsible for any fees related to unsolicited resumes.