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Spectraforce

Regulatory Information Management Contractor

Pay: Not specified

Posted: 3 weeks ago

Location: North Chicago, IL (Onsite)

Last Updated: 2 weeks ago

Hours: Full-Time

Expires: 10/5/2026

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What they do

A Clinical Data Analyst is responsible for gathering, compiling, modeling, validating, and analyzing clinical trial results data needed by pharmaceutical companies, governmental agencies, and biotechnology firms evaluate the effectiveness of their trial drugs. May be responsible for designing, testing, and implementing clinical data reporting systems for the clinical staff to use.

$73,036 / year median in Illinois

-10% projected decline

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Job Description

Position Title:

Regulatory Information Management Contractor Work Location:

North Chicago, IL 60064

Assignment Duration:

06 Months (possible extension)

Work Arrangement:

Onsite - Hybrid (Tues, Wed, Thurs)

Position Summary:

Monitors activity in COSMOS (Regulatory Information Management solution) for assigned products and activities, including ensuring completeness and accuracy of data

Key Responsibilities:

Monitors activity in COSMOS (Regulatory Information Management solution) for assigned products and activities, including ensuring completeness and accuracy of data
Follows agreed upon data standards for creating RIM objects, including but not limited to:
Create or update product, application, and registration data (e.g. new registration, new validity date period, new indication, new pack)
Commitment/Obligation recording and updating
Monitor that submission has been archived via CIU
Move activity to a completed status if a notification only activity
Monitor that Correspondence/responses from agency are imported into Cosmos in association with relevant activity
Response structures linked to relevant activity
Approval letter imported in relation to relevant activity; Activity status and date updated to reflect approval
Support Audit/Inspection requests related to data in Cosmos
Support system enhancements and data remediation activities
Support migration and harmonization of data during system upgrades, process improvements, and acquisitions

Qualifications & Experience:

Required Education:

Bachelor's degree in related life sciences (pharmacy, biology, chemistry, medical technology pharmacology)

Required Experience:

0-2 years in pharmaceutical, medical device or healthcare related field

Preferred Experience:

0-2 years in Regulatory Affairs or Regulatory Operations role

Good communication, both oral and written