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Senior Coordinator - Regulatory Submissions Operations (Publishing)
at Cardinal Health
What Regulatory Sciences and Submissions Operations contributes to Cardinal Health
Cardinal Health Regulatory Sciences partners with Pharma and Biotech companies to solve complex regulatory challenges and expedite the development process by applying a premier level of expertise and experience to every client engagement.
Regulatory Submissions Operations provide advanced formatting, proofreading, editing and compilation of paper and electronic documents related to the pharmaceutical industry throughout each phase of drug development; electronic processing, publishing and compilation of documents and complete submissions according to regulatory specifications in support of regulatory applications with appropriate agencies.
What is expected of you for success in your role
- Demonstrates specialized knowledge of preparation, formatting, copy, proof, and assembly of regulatory submissions and controlled documentation
- Assists publishers with tasks, such as pre-publishing (formatting, bookmarking, hyperlinking) and QC
- Uses various systems and tools (i.e. Toolbox (formerly referred to as ISI Toolbox), InSight Publisher, eCTDXpress, etc.) for compilation, formatting, assembly, etc.
- Applies knowledge/skills to a range of activities
- Completes work assignments with minimal supervision/guidance and high quality
Accountabilities in this role
- Builds regulatory submissions using specified processes, procedures and systems
- Creates navigation aids (i.e. bookmarks and hyperlinks) according to specified requirements
- Adds metadata to regulatory submissions per requirements
- Produces/publishes regulatory submissions in acceptable, compliant output according to specified guidelines and requirements
- Incorporates Quality Control (QC) review comments
- Intermediate knowledge of MS Word
- Basic knowledge of MS Excel
- Intermediate knowledge of Adobe Acrobat
- Working knowledge of spelling, grammar and punctuation
- High school diploma or equivalent
- Minimum of three years in office environment is preferred
- Minimum of one year in pharmaceutical industry is preferred