Regulatory Operations Documentation Specialist

Job Title: Regulatory Operations Documentation Specialist
Location: Florham Park, New Jersey
Type: 12-month Contract
Compensation: $31.00 – $54.00 per hour
Contractor Work Model: Remote
Hours: 40.0 hours per week

Overview
This role will support the Regulatory Operations team with the preparation of submission related documentation for electronic submission. The scope of this role includes assisting in document formatting, remediation and quality control (QC) of documentation for submissions to Health Authorities. The role also involves archiving correspondence with Health Authorities, as well as managing documents stored at or retrieved from offsite facilities. The ideal candidate will bring experience with Microsoft Word, Adobe Acrobat, and Veeva RIM.

Responsibilities

• Support document formatting and QC in alignment with standards for submission-related materials.
• Assist in the remediation and QC of PDF documents, including bookmarking and hyperlinking to ensure regulatory-compliant electronic files.
• Assist in ensuring all communications with health authorities are properly archived within the company’s system and adhere to applicable regulatory guidelines.
• Assist the archiving and retrieval of documents from offsite storage facilities.
• Provide ongoing support to the Regulatory Operations team.

• High school degree required; Associate’s degree preferred.
• Pharmaceutical industry experience is a plus, but not required
• 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.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. 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.

#M-
#LI-

Ref: #568-Clinical