Syneos Health

Regulatory Publishing Specialist, eCTD

Syneos Health

full-time

Posted on:

Location Type: Remote

Location: North Carolina • United States

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About the role

  • Support filtering, cleaning, migration, analysis, reporting and publication of regulatory data and information
  • Performs Assembler tasks within the document publishing system, including 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
  • Performs QC tasks within the electronic publishing system and QC of the published output
  • Creates, keys, and assembles client deliverable documents and submissions using standard word processing or publishing systems
  • Takes lead role in preparing full application submission builds
  • Troubleshoots issues with eCTD builds and provide guidance to entry level publishers
  • Reviews documents for legibility, completeness, and accuracy
  • Logs and tracks regulatory documents, publications, and other relevant materials
  • Prepares and assembles applications for submission to global regulatory authorities

Requirements

  • Moderate experience in a regulatory environment with preference given to drug/device/biologic-related industry
  • Experience with electronic publishing of regulatory submissions preferred
  • Good working knowledge of basic computer applications, e.g. MS Word/ PowerPoint/ Excel
  • Experience with relevant software such as Extedo’s eCTDManager and eSUBmanager, CoreDossier, ISI Toolbox, ISI Publisher, eCTDXpress, eValidator, Acrobat, Documentum, Ezsubs, IMS Word for Windows, and Access
  • 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
Benefits
  • Health benefits to include Medical, Dental and Vision
  • Company match 401k
  • Eligibility to participate in Employee Stock Purchase Plan
  • Flexible paid time off (PTO) and sick time
  • Company car or car allowance

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
regulatory data analysisdocument publishingeCTD formatQC tasksdata migrationdata cleaningreportingpublicationtroubleshootingsubmission preparation
Soft skills
communicationorganizationalinterpersonalattention to detailindependenceability to follow instructionsmultitasking