[Hiring] Senior Coordinator, Regulatory Submission Operations @Cardinal Health

Role Description

We currently have a career opening for a SR Coordinator Regulatory Submissions Operations.

Regulatory Submissions Operations uses specialized technology and knowledge to format, edit and compile paper and electronic documents related to the pharmaceutical industry regulatory submissions throughout each phase of drug development and through the drug product life cycle. This position provides application submission, prepares specialized electronic files for drug registrations, and oversees and maintains document management databases for version and revision control.

• 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

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.

Requirements

• Effectively applies knowledge of job and company policies and procedures to complete a variety of assignments.
• Applies advanced skills to resolve complex problems independently.
• May modify process to resolve situations.
• Works independently within established procedures; may receive general guidance on new assignments.
• May provide general guidance or technical assistance to less experienced team members.

Benefits

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs