SR Coordinator, Regulatory Submission Operations

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.  

We currently have a career opening for a SR Coordinator Regulatory Submissions Operations
*** Location
* ** Remote
* ** What Regulatory Submissions Operations contributes to Cardinal Health
*** Regulatory 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 though 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
* ** 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.

Additional responsibilities include:

* 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.
*** What is expected of you and others at this level
**** 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

Anticipated Pay Range $27.00 - $34.56 per hour USDBonus Eligible - No

Benefits:
Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
* Medical, dental and vision coverage
* Paid time off plan
* Health savings account (HSA)
* 401k…