Publishing Specialist

Job Description

We are currently seeking a Publishing Specialist to join our growing team. Within this role you will:

  • Manage end-to-end Publishing support for initial IND/NDA/MAA applications and the life cycle maintenance of all applications across the globe
  • Collaborate with various department for planning, preparation, publishing, and quality control checks of submissions
  • Develop submission-ready documents for electronic submissions including formatting, hyperlinking, and processing MS Word and Adobe Acrobat documents
  • Develop and maintain up-to-date knowledge of established agency standards and procedures for regulatory submissions
  • Support eCTD, NeeS/eSub, and Paper submission formats
  • Troubleshoot document issues with Adobe Acrobat and MS Word and identify gaps in the submission. Work to address identified issues with the respective client stakeholders
  • Manage technical aspects for assigned submissions and status updates
  • Perform quality checks on the published outputs, ensure no unacceptable warnings and validation errors before the submission with HA
  • Perform on the job training, to follow a train the trainer model for beginners/fellow colleagues and provide QC feedbacks for continuous improvements
  • Provide feedback to clients on the SOPs/process improvizations to achieve quick turnaround deliverables and immediate effort efficiencies to clie
  • Support project lead in in planning day-to-day activities and ensure timely deliverables are met as per client expectation
  • Provide scheduled training across the team to share process/HA updates and to maintain competency across the region/submission types
  • Effective co-ordination with cross-functional teams in receiving, tracking the documents, and addressing the gaps for effective project execution
  • Provide feedback to project lead on KPI trends and continuous improvements tin the day-today operations/proce

Desirable Skills and Experience

  • 8 to 10 years’ experience working in Regulatory Affairs
  • Strong analytical skills
  • Significant hands-on experience in the creation of submission output for eCTD, NeeS, and Paper submissions
  • Very strong knowledge of submissions to the US FDA and HC
  • Proven ability to successfully understand the submission and agency requirements
  • Effective coordination with cross-functional teams in receiving and tracking documents and addressing the gaps for effective project execution
  • Experienced in the execution of initial IND/ NDA/ MAA projects, as well as LCM submissions. Able to work with tight timelines and achieve first-time-right submissions with zero HA rejection
  • Proven strength in logical, analytical, and writing ability
  • Experience with the following tools would be advantageous: pharmaREADY®, Lorenz, Insight Publisher, Veeva Vault, eCTD Express, Extedo

Princeton, NJ, USA

Graduate/Post Graduate with a life sciences degree


Regulatory Affairs

Full Time