Regulatory Specialist

Description:

Regulatory Specialist-Scientific Writer

The Scientific Writing Team drafts study reports and study summaries to support regulatory submissions for both biotech and crop protection products. Scientific Writers collaborate closely with stakeholders and customers including Study Directors and Monitors, Subject Matter Experts, Quality Assurance, Statisticians, and Global Registration Teams.

Weekly Schedule (how many hours/days): 40 hours
• Shift Times: 8am-5pm

Any specific skills, requirements or experience you want in a candidate: BS Chemistry/BioChem, MS okay, PhD overqualified. Prior experience with scientific writing, GLP experience highly preferred, Strong attention to detail, capable of writing technical documents while understanding chemistry discipline

Job Summary
• Draft high-quality Product Chemistry study reports and study summaries to support Crop Protection regulatory submissions. Strong scientific writing skills and a background in chemistry or related science are needed for drafting reports.
• Perform quality control reviews on draft reports and/or raw data. An understanding of Good Laboratory Practice (GLP) is required.
• Assist in developing new report templates, optimize processes, and assess stakeholder feedback for continuous improvement.
• Facilitate finalization of reports and audit responses.
• Communicate effectively with key stakeholders and customers. Partnership with stakeholders and customers to understand regulatory reporting requirements is important for success.

Job Requirements and Qualifications:
• Bachelor’s degree or higher in Chemistry, Biochemistry, or a related scientific discipline.
• Demonstrated experience in scientific writing, preferably within the regulatory or crop protection industry.
• Strong understanding of Good Laboratory Practice (GLP) standards and regulatory guidelines.
• Excellent attention to detail and ability to perform quality control reviews on scientific documents and raw data.
• Proficient in using Microsoft Office Suite and document management systems.
• Effective communication and collaboration skills with cross-functional teams and stakeholders.
• Ability to manage multiple projects simultaneously and meet tight deadlines.