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

Position Summary:

* 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

Key Responsibilities:

* 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

Qualification & Experience:

* 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

Education:

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

Education - High school diploma