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Standard Operating Procedure Designer - Lincoln, Nebraska

LincolnHybridFull-time

AI Summary

A Standard Operating Procedure Designer defines, develops, implements, and maintains Celerion’s standard processes to meet global regulatory and governance requirements, leading project groups and coordinating training.

About this role

Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster.

Celerion is currently seeking a full-time Standard Operating Procedure Designer for our Lincoln, Nebraska location. After 6-8 weeks of on-site training, you will have the ability to work primarily from home, if desired. You will work with your team in person and on-site every other week.
In this position, you will define, develop, implement and maintain Celerion standard processes that adhere to company governance and global regulatory requirements.

Responsibilities:

  • Lead global project groups to obtain information needed to create global process documents.
  • Plan for and manage reviews of new and existing processes and standards to ensure completeness, consistency, quality and compliance with established requirements.
  • Manage document control and maintenance process for all Celerion processes and standards.
  • Ensure processes and standards are compliant with regulatory requirements, corporate governances and the Quality Management System.
  • Develop, coordinate and facilitate training programs for appropriate processes and standards.

    • Requirements:

  • Bachelor's degree in Life Sciences or related degree preferred
  • Excellent oral and written communication skills
  • High proficiency in MS Office applications and Adobe Acrobat
  • Excellent organization skills
  • Strong facilitation, presentation and training skills
  • Self-motivated and able to perform with minimal supervision

    • Skills

    Adobe AcrobatClinical Research ProcessesDocument ControlMS OfficeQuality Management SystemsRegulatory ComplianceSOP AuthoringTraining Facilitation

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