Description

Division SBI
City Research Triangle Park
State North Carolina [NC]
Function Research & Product Development
Position Title Biotechnology Regulatory Field Study Coordinator
Job ID 1284
Role Purpose/Accountabilities The Biotech Regulatory Field Study Coordinator will be responsible for coordinating the US field trial program and ensuring regulatory compliance throughout the process. This will include designing, implementing and the reporting of regulatory field trials required to support EPA, FDA and USDA submissions. Accountabilities will also include the coordination of APHIS trial notification/permit requirements and the creation and management of the field trial notebooks. The selected candidate will serve on Regulatory project team(s) to provide guidance on study strategy, cultivation locations, trial design and study timelines. In addition, the incumbent will ensure that the field studies meet the criteria and quality standards, including Good Laboratory Practice (GLP) compliance when necessary, Quality Management and APHIS requirements. The individual will also be expected to leverage this role to facilitate increased transparency and communication with the science functions, project planners and others who provide critical data and reports in support of biotech product registrations.

Accountabilities
In addition, the accountabilities for this position will include:
• Implementation of continuous improvement programs directed toward establishing consistent standards for how regulatory field studies are conducted with the goal of achieving aggressive timelines for successful approvals of biotech products.
• Interface directly with internal R&D functions and facilities as well as 3rd party organizations to complete the field phases of studies.
• Represent Syngenta in relevant industry associations and external technical committees (i.e. NAICC).
• Provide technical input to enable implementation of field programs for local cultivation approvals outside of the USA and support interactions with regulatory authorities worldwide on design of biotech field programs.
• Act as Study Director for some of the regulatory agronomic and efficacy field studies to deliver the necessary data to support product registrations.
• Perform all activities in accordance with the Syngenta Health, Safety, and Environmental Policy
Knowledge, Skills & Experience Critical knowledge
Ph.D. in Agronomy or related field. Will consider MS Degree with 5-10 years field experience, including project planning, execution and reporting of field study results a plus. Strong knowledge of GLP studies and common agronomic practices utilized in plot research. Additional knowledge of electronic FTN’s, electronic project tracking and report writing is essential for this position.

Critical experience
3-5 years of experience conducting field biotech crop studies with knowledge of regulatory requirements associated with development of biotech crops, and experience working in a diverse project team environment.

Critical technical, professional and personal capabilities
Strong project management and people leadership skills. Ability to effectively work in an interdepartmental team environment to manage project timelines in support and success of biotech product registrations.
Additional Information • A minimum of 2 years in current position is required (requirement for internal applicants only)
• All applicants must be eligible to work in the US.
• Travel requirements – Some travel may be required.
http://careers2.hiredesk.net/ViewJobs/JobDetail.asp?Comp=Yoh&TP_ID=1&PROJ_ID={A72180B8-1B6E-4B8B-8BA2-47BBDBA642E9}&LAN=en-US

Tags:
Stats:

Item Location

Images

There are no images

Sponsored Links

Comments are closed.