SR Coordinator, Regulatory Submission Operations

About the role

Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a global, integrated healthcare services and products company connecting patients, providers, payers, pharmacists and manufacturers for integrated care coordination and better patient management. Backed by 50+ years of experience, with more than 50,000 employees in nearly 60 countries, Cardinal Health ranks among the top 20 on the Fortune 500. We boast tremendous opportunities to grow and apply technical skills to meet organizational needs, empowering talented team members who mentor and uplift others, led by leaders with a focus on employee development and well-being, dedicated training programs, and a collaborative atmosphere.

The SR Coordinator Regulatory Submissions Operations role supports Cardinal Health Regulatory, which provides regulatory affairs and product development consulting services to enable pharmaceutical, medical and biotechnology companies to obtain regulatory approvals. This function applies subject matter expertise to provide services in technical writing and regulatory submissions as well as clinical research and manufacturing process consulting. 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 job family provides application submission and renewal services for state licensing activities, prepares specialized electronic files for drug registrations, drug listings and self-identification, and oversees and maintains document management databases for version and revision control.

Responsibilities

• Use specialized technology and knowledge to format, edit and compile paper and electronic documents related to pharmaceutical industry regulatory submissions throughout each phase of drug development and through the drug product life cycle.
• Provide application submission and prepare specialized electronic files for drug registrations.
• Oversee and maintain 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 (required).
• QA, QC, and SOP experience (major plus).
• Experience in formatting and editing Adobe documents (required).
• Familiarity with Excel (required).
• Editorial and data analysis experience (plus).
• Project management experience (plus).
• Willingness to learn scientific principles.
• Attention to detail.
• Strong written and oral communication skills.

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