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    Publishing Specialist

    Navitas Life Sciences
    8-10 years
    Not Disclosed
    Princeton Junction
    10 July 26, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Description: Publishing Specialist

    We are seeking a Publishing Specialist to join our growing team. In this role, you will manage the end-to-end publishing support for regulatory submissions, ensuring high-quality outputs and adherence to agency standards.

    Core Responsibilities:

    Publishing Management:

    • Submission Support: Oversee the complete publishing process for initial IND/NDA/MAA applications and their lifecycle maintenance globally.
    • Document Preparation: Develop submission-ready documents for electronic submissions, including formatting, hyperlinking, and processing MS Word and Adobe Acrobat documents.

    Collaboration and Coordination:

    • Cross-Department Collaboration: Work with various departments to plan, prepare, publish, and perform quality control checks on submissions.
    • Technical Troubleshooting: Address document issues with Adobe Acrobat and MS Word, and work with client stakeholders to resolve identified gaps.

    Quality Control and Training:

    • Quality Checks: Perform quality checks on published outputs, ensuring no unacceptable warnings and validation errors before submission to health authorities (HA).
    • Training and Feedback: Conduct on-the-job training following a train-the-trainer model for beginners and provide QC feedback for continuous improvement.
    • Process Improvements: Provide feedback to clients on SOPs and process improvements to enhance turnaround times and efficiency.

    Project Support:

    • Project Planning: Assist the project lead in planning daily activities and ensuring timely deliverables meet client expectations.
    • Scheduled Training: Provide training across the team on process and HA updates to maintain competency.

    Documentation and Coordination:

    • Document Tracking: Coordinate with cross-functional teams to receive, track, and address document gaps for effective project execution.
    • KPI Feedback: Offer feedback to the project lead on KPI trends and suggest continuous improvements in day-to-day operations and processes.

    Desirable Skills and Experience:

    • Experience: 8 to 10 years in Regulatory Affairs with hands-on experience in creating submission outputs for eCTD, NeeS, and Paper submissions.
    • Knowledge: Extensive knowledge of submissions to the US FDA and Health Canada (HC), with a proven ability to understand submission and agency requirements.
    • Execution: Proven track record of successful execution of initial IND/NDA/MAA projects and lifecycle maintenance submissions, achieving first-time-right submissions with zero HA rejections.
    • Analytical Skills: Strong analytical and logical skills with a keen eye for detail and accuracy.
    • Tools Experience: Familiarity with tools such as pharmaREADY®, Lorenz, Insight Publisher, Veeva Vault, eCTD Express, and Extedo is advantageous.
    • Coordination: Effective coordination with cross-functional teams, demonstrating strong organizational and communication skills.

    This role is ideal for a detail-oriented and experienced professional with a strong background in regulatory submissions and a passion for maintaining high-quality standards in publishing.

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