Operations Support Associate

Position Title: Operations Support Associate

Work Location:

North Chicago, IL 60064
Assignment Duration: 12 Months

Work Schedule:

First shift (day shift) Flexible working hours Typical core hours around 9:00 AM to 4:00 PM

• Work Nature
  - High-volume, fast-paced, very active workload
• Support document management activities for non-clinical / preclinical safety documents
• Perform formatting, bookmarking, linking, and document organization
• Ensure documents are accurate, well-formatted, and ready for submission

• Format documents using Microsoft Word
• Perform bookmarking and linking using Adobe tools
• Use internal tools/overlays (training will be provided)
• Manage and organize documents in the electronic submission system (document repository)
• Support preparation of documents for regulatory submissions
• Work on documents across the entire lifecycle:
  • Study initiation documents
  • Internal communications
  • Reports and summaries
  • Regulatory submission documents (IND, BLA, etc.)
• Ensure document quality, consistency, and accuracy
• Identify issues proactively and communicate them early
• Work collaboratively with scientists, CROs, and internal teams
• Handle high volume of documents efficiently
• Maintain timelines and deliverables

• Strong communication skills
• Good attention to detail
• Ability to learn quickly
• Ability to work independently after training
• Strong organizational skills
• Ability to handle high workload and multitask
• Proactive mindset, raise issues early
• Strong team collaboration skills
• Positive attitude and ability to fit into team culture
• Experience in document formatting or document management
• Familiarity with Adobe Acrobat (bookmarking/linking)
• Experience with electronic document systems/repositories
• Exposure to pharma / clinical / regulatory environment
• Knowledge of regulatory submissions (IND, BLA, etc.)
• Administrative or coordination experience
• Strong focus on skills and attitude over experience

• Bachelor's Degree preferred but not mandatory (open to candidates without a degree if they have the right skills)
• Pharma or regulatory experience, preferred but not required
• Document management or admin experience, helpful but not mandatory
• Open to fresh graduates and candidates with no clinical/regulatory background
• Strong focus on skills and attitude over experience
• High school diploma