Documentation Management Specialist

3 days ago


Rahway, New Jersey, United States Intelliswift Full time
Job Summary

We are seeking a skilled Documentation Management Specialist to join our team at Intelliswift. In this role, you will be responsible for supporting the operational aspects of procedural documentation management and advising on documentation strategy for our Global Regulatory Affairs & Clinical Safety (GRACS) organization.

Key Responsibilities
  • Support and manage the creation/revision of Regulatory Affairs and Global Pharmacovigilance Procedural Documentation, including Standard Operating Procedures, Job Aids, Forms, Process Guides, and User Manuals.
  • Develop and manage integrated project plans, lead and/or complete documentation impact assessments, and support process owners in the development of process maps.
  • Facilitate documents through draft, review, and approval cycles to meet required timeframes for release and implementation.
  • Conduct periodic assessments of procedural content to ensure adherence to format, content, and style guidelines, and identify improvement opportunities.
  • Maintain and organize current effective documentation within logical groupings/categories to facilitate ease of access for GRACS end users.
  • Support and manage requests for documentation for GRACS internal audits and inspections for process documentation.
Requirements
  • Bachelor's degree or higher in a relevant field.
  • 6+ years of industry experience and familiarity with Veeva Vault Quality Docs.
  • Excellent communication and project management skills.

Please note that 3 days of onsite work are required for this role, and the candidate can be local to Upper Gwynedd, PA, or Rahway, NJ.



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