Registration Manager and Senior Study Director

Website NCSU

About the Department The IR-4 Project is a national Federal/State partnership research program to assist farmers of fruits, vegetables, nuts, herbs, ornamentals and other specialty crops by facilitating registration of safe and effective chemical and bio-based pest management products. The IR-4 Project is needed because the crop protection industry focuses their research efforts on major crops such as corn, soybean and cotton that provide the companies adequate return on their development investment.

Without IR-4, farmers of specialty crops would only have access to a few crop protection products to protect their crops. IR-4 Project Headquarters provides national leadership, coordination and regulatory compliance for the IR-4 Project research activities performed by approx. 125 scientists at over 20 public sector research farms and five analytical laboratories throughout the United States.

Essential Job Duties Reporting to the Executive Director, the IR-4 Project Registration Manager & Senior Study Director is responsible for:

  • Supervising the various disciplinary working groups on the preparation of protocols, reviewing research data and preparation of regulatory documents for submission to industry and EPA and assisting registrants with labeling.
  • Coordinating with the Assistant Director for Research Planning and Product Performance on field/laboratory research and regulatory activities.
  • Coordinating with the National Quality Assurance Unit Manager to insure that data comply with federal Good Laboratory Practice Standards.
  • Maintaining appropriate records documenting progress of the Project in fulfilling its mission of providing safe and effective pest management for specialty crops and minor uses.
  • Serving as Study Director as needed.
  • Performing other duties as assigned by the Associate Director of Regulatory Sciences.

Duties and Expectations include:

  • As team leader, coordinate the IR-4 Registration Group (Study Directors): Assist Study Directors in protocol review and preparation; serve as sponsor representative for protocols and amendments or deviations to the protocol. Provide technical support and advice to the Study Directors for study conduct and regulatory package preparation. Provide support to the Study Directors to assure that protocols and studies are completed in an efficient and timely manner.
  • Participate in partnership initiatives: Foster strong relationships with IR-4 partners. These partnerships include: EPA, chemical Companies, Growers and Commodity Groups, and the Project Management Committee. Maintain communications with partners/stakeholders (EPA, growers and requestors, chemical companies) on a timely basis to keep them informed of IR-4 progress. Provide up dates at IR-4 meetings, and accompany the Executive Director at chemical company technical meetings. Provide information to partners and provide ideas for new initiatives and regulatory strategies that would result in a more efficient use of resources.
  • Coordinate project priorities with the National Quality Assurance and Planning and Product Performance Research Units: Coordinate research and registration (including Quality Assurance) resources to meet timelines and provide an efficient use of IR-4 resources. Schedule routine meetings with the National Quality Assurance Unit Manager and Executive Director to assure that projects, especially high priority projects, are moving through the system in a timely manner. Anticipate potential problem areas and propose solutions and alternatives to the Leadership Team.
  • Study Director: Serve as Study Director by providing technical oversight of assigned studies (research coordination, data review) and ensure that research proceeds as planned. The Study Director communicates and cooperates with numerous individuals (including Field Research Directors, Regional/ARS Field Research Coordinators, Registrant representatives, Quality Assurance personnel and EPA personnel) to maintain involvement in all facets of the research. Assist other Study Directors in coordinating research and problem solving. Prepare quality reports that are easily reviewed by all parties (QA, MFGEPA). Close data gaps, correct format, consistently meet timeline.

The position will also perform other duties as assigned by the Executive Director and must be willing to travel to conduct audits and attend major IR-4 meetings throughout the United States.

Other Responsibilities Other duties as assigned.
Minimum Experience and Education
  • Master’s degree in analytical chemistry, the plant protection sciences (Entomology, Plant Pathology, Weed Science), horticulture, or related field, with 7 years’ of relevant experience.
Other Required Qualifications
  • Must have a comprehensive understanding of US EPA Good Laboratory Practice regulations and current best compliance practices.
  • Ability to maintain attention to details, and prioritize and meet deadlines.
  • Excellent oral, written, and interpersonal skills.
Preferred Qualifications
  • PhD in analytical chemistry, the plant protection sciences (Entomology, Plant Pathology, Weed Science), horticulture, or related field.
  • Documented GLP training or similar coursework and 5 years of experience as a study director.
  • Experience building partnerships among diverse stakeholder groups.

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