Regulatory Publisher II

Responsibilities and Activities
Submissions Publishing
* Publishing of routine regulatory documents: Clinical Protocols, Study Reports, CMC, and other CTD-related documents using company templates.
* Format and Style Guide proofing of formatted documents using internal guidelines. When applicable, ensures that all documents are cross-checked and/or QC'ed by appropriate resource.
* Assembly of regulatory submissions as directed by supervisor and/or Director of Regulatory per company practices and guidelines.
* Independent assembly of routine regulatory submissions (e.g., Investigator updates).
* Proactively enforce version control of all regulatory documents.
* Maintain electronic and paper files of regulatory submissions and regulatory controlled documents.
* Monitor regulatory submission supplies to confirm adequate inventory for upcoming submissions.

Documentation Coordination

* Assist with approval process and workflow of documents.
* Issue and archive documents.
* Assist in version control and tracking of documents in development.
* Provide support with compliance activities.

Infrastructure Support

* Under guidance of Supervisor, create documentation, work instructions, and checklists for publishing procedures and specifications that represent company and regulatory guidelines.
* Assist Supervisor in maintaining templates
* Assist Quality in formatting/editing of SOPs
To find out more about Real please visit www.realstaffing.com