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 Apply for this job Apply tot his job Apply To this Job