Regulatory Operations Documentation Specialist - Florham Park
6 hours ago
Job description
Job Title:
Regulatory Operations Documentation Specialist (Contractor)
Location:
Florham Park, New Jersey
Type:
Contract
Compensation:
$40 - $57 hourly
Contractor Work Model:
Remote
Overview
The Regulatory Operations Document Specialist Contractor will focus on formatting documents based on company standards and support remediation efforts by bookmarking, hyperlinking, and performing quality control measures to ensure our work product is compliant with our electronic submissions.
In addition, this assignment will focus on providing general assistance to the Regulatory Affairs team whilst focusing on supporting Regulatory Operations.
ResponsibilitiesAssist in performing document formatting per company standards for submission related documentation.
Assist in the remediation of PDF documents by bookmarking, hyperlinking and QCing to ensure compliant electronic files.
Provide support to the Regulatory Operations team.
Provide general assistance to the Regulatory Affairs department as needed.
Minimum Requirements
High school degree required, associate's degree preferred.
2 years minimum experience in regulatory affairs within a pharmaceutical or biotechnology company.
Proficient in MS Office and Acrobat Adobe.
Experience with ISI Toolbox or equivalent software packages.
Experience with database systems; Veeva is a plus.
High level of attention to detail and accuracy in work.
Effective time management and organizational skills.
Strong written and verbal communication skills.
Able to work within a high-performance, collaborative team environment.
Assist in performing document formatting per company standards for submission related documentation.
Assist in the remediation of PDF documents by bookmarking, hyperlinking and QCing to ensure compliant electronic files.
Provide support to the Regulatory Operations team.
Provide general assistance to the Regulatory Affairs department as needed.
System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America.
System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer.All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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Regulatory Operations Documentation Specialist
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