FMC
GLP Coordinator
Onsite in Stine, DE 5 days a week Business/Function Overview: The FMC Global Research and Development Analytical Sciences team is seeking a detail-oriented GLP Coordinator with strong skills in scientific writing and project management. In this role, you will coordinate GLP studies, track milestones, and support study execution while also serving as a primary author of regulatory-compliant reports. You will work closely with study directors and laboratory staff to ensure that projects are well-organized, data is processed accurately, and reports are delivered on time and in compliance with GLP standards. The ideal candidate combines excellent organizational skills and GLP operational knowledge with the ability to translate complex analytical data into clear, concise, and compliant reports. Responsibilities: Coordinate GLP analytical studies, including project placement, assignment, and milestone tracking. Collaborate with scientists, analysts, and QA personnel to gather and verify study data. Assist staff in data processing, ensuring accuracy and compliance prior to reporting. Author detailed technical reports for GLP analytical studies that meet global regulatory standards. Summarize and present complex scientific data in a clear and concise manner. Maintain current knowledge of Global GLP regulations, industry best practices, and analytical methodologies. Assist in developing and maintaining Standard Operating Procedures (SOPs) and other regulatory documentation in compliance with US EPA Good Laboratory Practice Standards (40 CFR Part 160/792) and EU SANCO/825/00 rev. 5 guidance for global study submissions. Manage multiple projects simultaneously, ensuring timely and high-quality deliverables. Continuously improve reporting and coordination processes through feedback and new approaches. Required Education: Bachelor's degree in Chemistry, Biology, Biochemistry, or a related field. Minimum of 5 years of experience in scientific or technical writing, preferably in a GLP regulatory environment. Qualifications: Strong understanding of GLP regulations and compliance requirements. Proficiency in analytical techniques such as HPLC, GC, LC-MS, or related methodologies. Experience with data processing software (e.g., OpenLab, Analyst). Excellent written and verbal communication skills. Strong organizational skills and attention to detail. Ability to interpret, analyze, and present scientific data accurately. Proficient in Microsoft Office Suite and scientific data management systems. Capable of working independently and collaboratively across teams. Demonstrated ability to manage multiple projects under tight deadlines. Strong problem-solving and critical-thinking skills. Preferred Qualifications: Experience in the pharmaceutical, biotechnology, agrochemical, or environmental science industries. Familiarity with international GLP requirements, including US EPA GLP standards (40 CFR Part 160/792), OECD principles of GLP, and EU SANCO/825/00 rev. 5 guidance. Understanding of regulatory submission requirements across multiple regions (e.g., US, EU, OECD member countries). Experience preparing compliance documentation for global regulatory dossiers. Certification in technical writing, scientific communication, or regulatory affairs (preferred).
Onsite in Stine, DE 5 days a week Business/Function Overview: The FMC Global Research and Development Analytical Sciences team is seeking a detail-oriented GLP Coordinator with strong skills in scientific writing and project management. In this role, you will coordinate GLP studies, track milestones, and support study execution while also serving as a primary author of regulatory-compliant reports. You will work closely with study directors and laboratory staff to ensure that projects are well-organized, data is processed accurately, and reports are delivered on time and in compliance with GLP standards. The ideal candidate combines excellent organizational skills and GLP operational knowledge with the ability to translate complex analytical data into clear, concise, and compliant reports. Responsibilities: Coordinate GLP analytical studies, including project placement, assignment, and milestone tracking. Collaborate with scientists, analysts, and QA personnel to gather and verify study data. Assist staff in data processing, ensuring accuracy and compliance prior to reporting. Author detailed technical reports for GLP analytical studies that meet global regulatory standards. Summarize and present complex scientific data in a clear and concise manner. Maintain current knowledge of Global GLP regulations, industry best practices, and analytical methodologies. Assist in developing and maintaining Standard Operating Procedures (SOPs) and other regulatory documentation in compliance with US EPA Good Laboratory Practice Standards (40 CFR Part 160/792) and EU SANCO/825/00 rev. 5 guidance for global study submissions. Manage multiple projects simultaneously, ensuring timely and high-quality deliverables. Continuously improve reporting and coordination processes through feedback and new approaches. Required Education: Bachelor's degree in Chemistry, Biology, Biochemistry, or a related field. Minimum of 5 years of experience in scientific or technical writing, preferably in a GLP regulatory environment. Qualifications: Strong understanding of GLP regulations and compliance requirements. Proficiency in analytical techniques such as HPLC, GC, LC-MS, or related methodologies. Experience with data processing software (e.g., OpenLab, Analyst). Excellent written and verbal communication skills. Strong organizational skills and attention to detail. Ability to interpret, analyze, and present scientific data accurately. Proficient in Microsoft Office Suite and scientific data management systems. Capable of working independently and collaboratively across teams. Demonstrated ability to manage multiple projects under tight deadlines. Strong problem-solving and critical-thinking skills. Preferred Qualifications: Experience in the pharmaceutical, biotechnology, agrochemical, or environmental science industries. Familiarity with international GLP requirements, including US EPA GLP standards (40 CFR Part 160/792), OECD principles of GLP, and EU SANCO/825/00 rev. 5 guidance. Understanding of regulatory submission requirements across multiple regions (e.g., US, EU, OECD member countries). Experience preparing compliance documentation for global regulatory dossiers. Certification in technical writing, scientific communication, or regulatory affairs (preferred).