Remote Senior Regulatory Submissions Coordinator

Cardinal Health, Inc.; Northern (KY); Hybrid; USD 37,000 - 48,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

401k savings plan

Paid parental leave

Health savings account (HSA)

Job summary

Cardinal Health, Inc. is seeking a Senior Coordinator for Regulatory Submissions Operations to support regulatory affairs and product development through formatting, editing and submission of documents across drug development stages.

This remote role requires meticulous attention to detail, proficiency with Word, Excel and Adobe tools, plus strong communication and project management skills; experience with SOPs is a plus.

Qualifications

• Experience in advanced formatting of Microsoft Word documents is required.
• QA, QC, and SOP experience is a major plus.
• Experience in formatting and editing Adobe documents required.
• Familiarity with Excel required.
• Editorial and data analysis experience is a plus.
• Project management experience is a plus.
• Willingness to learn scientific principles.
• Attention to detail.
• Strong written and oral communication skills.

Responsibilities

• Format, edit and compile regulatory documents across the drug development life cycle.
• Provide submission support and maintain document management databases.
• Assess and negotiate timelines.
• Manage client documents used in submissions.
• Process client documents within publishing software.
• Identify concerns and communicate with upstream and downstream partners.

Skills

Advanced Word formatting

QA/QC/SOP experience

Editorial and data analysis

Attention to detail

Strong communication skills

Willingness to learn scientific princ

Project management

Tools

Adobe Acrobat/Editing

Microsoft Word

Excel

Job description

Cardinal Health, Inc. is seeking a Senior Coordinator for Regulatory Submissions Operations to support regulatory affairs and product development through formatting, editing and submission of documents across drug development stages.

This remote role requires meticulous attention to detail, proficiency with Word, Excel and Adobe tools, plus strong communication and project management skills; experience with SOPs is a plus.