Sr Publishing Consultant

Job Summary

Senior Publishing Consultant

Role overview

Job Title: Senior Publishing Consultant

Location: Gurugram/Hyderabad (Hybrid)

6+ Years Regulatory Publishing Experience | BA/BS (Science Preferred)

Responsibilities

• 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, compliance checking, Hyper-linking, bookmarking, rendering multiple documents to PDF, creation of external links, completion of Modules 1-5 in eCTD format, compilation of NeeS, compilation of paper submission, publishing and validation.
• Performs Publishing tasks within the electronic publishing system, including, but not limited to, adding special sheets, applying rules, preparing for publishing, and publishing.
• Performs QC tasks within the electronic publishing system and QC of the published output, including internal QC and QC of client documentation.
• Creates, keys, and assembles client deliverable documents and submissions using standard word processing or publishing systems and utilities (Extedo s eCTDManager and eSUBmanager, ISI Toolbox, ISI Publisher, eCTDXpress, eValidators, Acrobat and others).
• Takes lead role in preparing full application submission builds.
• Troubleshoots issues with eCTD builds and provide guidance to the entry level publishers.
• Reviews documents for legibility, completeness, and accuracy.
• Logs and tracks regulatory documents, publications, and other relevant materials.
• Organizes and compiles regulatory documentation, perform pagination, clean-up, and duplication tasks.
• Receive and deliver client information/documents.
• Prepares and assembles applications (INDs, NDAs, ANDAs, DMFs, variations, routine reports, renewals etc) for submission to global regulatory authorities.
• Able to prioritize and multi-task a number of projects.

Qualifications

• BA/BS with preference given to a science degree and/or moderate experience in a regulatory environment with preference given to drug/device/biologic-related industry, and experience with electronic publishing of regulatory submissions preferred.
• Good working knowledge of basic computer applications, eg MS Word/ PowerPoint/ Excel.
• Good experience with relevant software such as Extedo s eCTDManager and eSUBmanager, ISI Toolbox, ISI Publisher, Veeva RIM, eValidators, Acrobat, Documentum.
• Knowledge of medical/scientific terminology, ICH guidelines and regulations and procedures preferred. Knowledge of submission requirements of various markets such as USFDA, EMA etc an advantage.
• Good communication, organizational, and interpersonal skills.
• Ability to work independently and to understand and carry out detailed instruction.
• Attentive to the detail and accuracy of information.
• Ability to work concurrently on several projects, each with specific instructions that may differ from project to project.

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