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Electronic Submissions Specialist

Expired Job

Apex Systems Lake Zurich , IL 60047

Posted 2 months ago

This job was posted by : For more information, please see: DescriptionApex Life Sciences is looking for an Entry Level Regulatory Affairs Submission Specialist.

This is a 6 month contract to hire position with a growing Pharmaceutical company! No prior Regulatory Affairs experience needed!!Entry Level Regulatory Affairs Submission Specialist

Minimum Requirements:
BA/BS (no preference for type of degree)Technology skills (Adobe-hyperlink and bookmark, Word-formatting)Organized, ability to multitask, change and shift priorities quickly

Ability to work independently, but still contribute to a team deadline


Regulatory publishing experience is a plus, but not required?StyleguideOCR - Optical Character Recognition

Job Description:
Prepare FDA submissions

Hyperlink documents in AdobeReview regulatory documents

Cross reference document naming conventions

Responsible for inspecting documents and doing general quality checks

Collaborate with labeling department

Preferred Experience:Knowledge of FDA complianceICH-GCPRegulatory Affairs PublishingTrial Master File (TMF) compliance and maintenance

ShiftMonday-Friday 8-5Not much OT required, will know in advance if required to work OT6 month-1 year contract to hire positionEEO EmployerApex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.

Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or .VEVRAA Federal ContractorWe request Priority Protected Veteran & Disabled Referrals for all of our locations within the state.We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. The EEO is the Law poster is available here.



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Electronic Submissions Specialist

Expired Job

Apex Systems