Summary:

The Regulatory Submission Specialist executes and maintains document management processes and electronic common technical document publishing processes in a validated internal system enterprise, and serves as first-line document management system support for internal and external stakeholders.

Position Overview:

The Regulatory Submission Specialist performs desktop publishing for regulatory submission documents and enterprise publishing for FDA regulatory submissions in eCTD format. The position also supports Clinical Operations in the tracking, preparation, and finalization of Clinical Study Reports within the enterprise document management system, and liaisons with Clinical Quality Assurance (CQA) to process the Clinical Study Reports through the CQA approval process. The position also requires maintenance of eCTD life-cycle document management strategies within the document management system, and maintaining the eCTD Software Suite database and eCTD Viewer docbase/regulatory submission archives as directed.

Additionally, the position will provide first line user support and training to internal and external stakeholders on the function and use of the company’s enterprise document management system.

Duties and Responsibilities:

§         Electronically publish regulatory submission documents, including clinical study reports, to industry and company defined standards

§         Electronically publish regulatory submissions using the eCTD software suite to industry and company defined standards

§         Serve as a primary user and business expert of the eCTD software suite

§         Provide business user support for the workflow of regulatory submission documents through the document management system

§         Assist business users in the development of business processes for the use of the document management system

§         Execute assigned activities for eCTD life-cycle document management within the document management system and the eCTD software suite

§         Execute, adhere to, and recommend improvements to Regulatory Operations work practices and guidelines

§         Execute Regulatory Operation’s  quality assurance processes on electronic submission documents and the validation processes for eCTD submissions as directed

§         Maintain the eCTD word processing templates and train users on their functionality

§         Maintain the eCTD viewing system docbase archives/regulatory submission archives

§         Execute computer system validation test scripts as directed

Experiences Desired:

§         2+ years in the pharmaceutical industry Regulatory Operations arena is required

§         2+ years of hands on experience with an eCTD Software System is required; experience with Datafarm’s S-cubed product is desired

§         2+ years of advanced user skills using Microsoft Word and Adobe Acrobat desktop publishing techniques for regulatory submission documents are required

§         2+ year of user experience within an enterprise Document Management System is required

§         1+ year user experience with Documentum based products is required. Experience with the FirstDocs Documentum interface desired. Experience with Documentum Virtual Document management is desired.

§         Knowledge of the industry standards for desktop publishing regulatory submission documents, including Case Report Forms, to eCTD readiness is required

§         Experience publishing Clinical Study Reports to ICH E3 standards for use in eCTDs is required

§         Experience on a cross-disciplinary Regulatory Submission Team from the Regulatory Operations services perspective is desirable

§         Experience with Microsoft Excel and Microsoft Project is desirable

§         General knowledge of Computer System Life Cycle Management techniques are a plus

§         BA/BS degree is preferred