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Regulatory Consulting
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20005994 Requisition #

Summary:       


Under limited supervision, performs detailed and confidential project-related duties directly related to regulatory compliance such as advanced document-level compilation and publishing services for agency correspondence including original and maintenance submissions for Investigational New Drug Applications (INDs), Clinical Trial Application (CTAs), Drug Master Files (DMFs),  Abbreviated New Drug Applications (ANDAs), New Drug Applications (NDAs), Biologic License Applications (BLAs), Orphan Drug Applications (ODD) and Health Canada submissions.  May also perform limited general administrative duties.  Responsibilities typically include creating and editing regulatory reports, conducting research to determine inclusion in the publication, summarization of data in the public domain, conduct quality control review of documents, and may also include collection and analysis of data to produce reports.

 

 

Job Responsibilities:


Create and assemble client deliverable documents and submissions using standard word processing or publishing systems and utilities (publishing software such as Extedo, InSight Publisher, CoreDossier, ISIToolbox, Acrobat, WORD and EXCEL).

Prepare, assemble and submit applications (INDs, NDAs, BLAs, ANDAs, DMFs, etc.) for submission to ensure compliance with government acts and regulations.

Performs Assembler tasks within the document publishing system, including, but not limited to, creating publications, modifying outline, assigning and transforming documents, and adding cross references, links and hyperlinks.

Performs Publishing tasks within the electronic publishing system, including, but not limited to, adding special sheets, applying rules, preparing for publishing, publishing and submitting via the ESG (Electronic Submissions Gateway).

Performs QC tasks within the electronic publishing system and QC of the published output.  May QC materials prepared by team or client.  Conducts quality control review of documents.

May organize and compile regulatory documentation, perform pagination, cleanup, and duplication tasks.

Understand, interpret and apply Agency regulations and guidelines related to eCTD submissions.

Participate in submission team meetings to plan and track submissions and relevant documents as assigned.  May log and track regulatory documents, publications, and other relevant materials.

May interface with the customer for their reporting needs, providing guidance as appropriate on the content of the customer’s reports.

Attends client meetings as needed.

Communicate with Information Technology group regarding issues and updates with publishing software.

May provide guidance to support personnel.

QUALIFICATION REQUIREMENTS

 

·       Associate’s degree preferred. 

·       Strong experience in an office environment, with pharmaceutical/medical device or CRO experience preferred.

·       Adobe Acrobat Professional and ISI Toolbox experience preferred.

·       Strong proficiency in Microsoft Office Suite (Word, Excel) preferred. 

·       Must have above average attention to detail, editorial and proofreading skills, accuracy, problem solving and organizational, interpersonal, and team-oriented skills. 

·       Ability to perform numerous tasks simultaneously without losing sight of overall objectives. 

·       Ability to work independently as well as part of a team and to keep others informed of the progress and status of writing projects.

·       Adaptable to changes in work duties, responsibilities, and requirements.

·       Knowledge of FDA and EU requirements, ICH regulations and ISO standards as applicable to regulatory documents preferred.