Publishing Specialist

Navitas Life Sciences

Princeton, NJ

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: , Lorenz, Insight Publisher, Veeva Vault, eCTD Express, Extedo

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Vacancy posted 16 hours ago

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