Experienced Regulatory Publishing Associate

Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Publishing Associate to join our Regulatory Affairs team in Cincinnati. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.

• Publish Clinical Study Reports, IND documents, NDA documents, and other regulatory documents according to ICH, eCTD, and other applicable electronic publishing standards;
• Implement publishing processes across multiple complex regulatory documents;
• Perform document quality control checks for others in the department, promptly communicating irregularities in documents and coordinating issue resolution;
• Provide day-to-day department support activities as necessary to aide completion of documents, including Clinical Study Reports, Report Appendices, Protocols, etc.;
• Support management with the conduct of procedural and software training
• Develop understanding and maintain knowledge of appropriate standard operating procedures (SOPs), regulations, policies, and regulatory guidance documents; and
• May be responsible for other projects and responsibilities as assigned

• Bachelor’s Degree;
• 2-3 years experience in management of submissions to regulatory authorities;
• Experience in eCTD Management software; GlobalSubmit, Adobe and ISI toolbox experience preferred;
• Demonstrates a high attention to detail;
• Ability to successfully train under the more advanced Specialists on how to perform all aspects of the job;
• Strong communication skills and ability to work with a diverse group of people.