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    Job · 19692900

    Bristol-Myers Squibb logo

    Submission Senior Specialist

    Bristol-Myers Squibb · Hyderabad · onsite · Posted 23d ago

    Undisclosed6–11 yrsfulltimeSourced fromNaukri

    About a minute. You'll make an account on the way through.

    About this role

    Key Responsibilities
    • Tracks, collects and reviews all components for routine submissions to Health Authorities
    • Interacts with responsible parties to ensure quality submission documents for routine submissions
    • Troubleshoots issues found in components received and coordinates with responsible parties for clarification or revision
    • Builds and manages dossier structures in Lorenz Docubridge for global CMC submissions
    • Builds, compiles, and publishes eCTD submissions in-house using Veeva Vault RIM
    • Distributes, tracks, and archives non-eCTD submissions globally
    • Drafts eCTD content plans for CMC submissions
    • Independently prepares Cover Letters, FDA Forms, and submission content plans for routine maintenance and Investigational submissions
    • Performs submission verification on published submissions to confirm eCTD compliance
    • Maintains and updates submission tracking data in Verity (Veeva Vault) - planned, in-progress, and submitted submissions
    • Lead contact to ensure Literature References are correctly maintained in Verity (Veeva Vault)
    • Assists with translation document management activities
    • Supports process and system improvement initiatives (e. g. , submission tracking tools, workflow enhancements)
    • Other miscellaneous regulatory operational activities as needed (e. , US export waivers)


    Qualifications Experience
    • BA/BS degree, science/technology field preferred
    • 6+ years relevant submissions and publishing experience


    Key Competency Requirements
    • Must have working knowledge of CMC/Quality dossier sections (e. g. , Module 3 structure) to accurately compile and publish submission content
    • Foundational knowledge of global regulatory practices, electronic submission guidelines and requirements
    • Communicates questions and issues as they arise with possible solutions
    • Supports other functions as appropriate
    • Participates in submission team meetings
    • Effective written and verbal communication skills
    • Works with supervision
    • Ability to prioritize and strong attention to detail
    • Comfortable working with electronic docbases, databases, publishing systems, and eCTD viewers; technically savvy with Veeva Vault RIM, Lorenz Docubridge, Microsoft Office, and web-based applications


    Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

    Sourced from naukri

    Skills

    Document Managementdata privacyHP data protectorCMCworkflowoperationsfinanceMS OfficeRecruitmentpublishing

    About Bristol-Myers Squibb

    Bristol-Myers Squibb logo

    Bristol-Myers Squibb

    Pharma

    375

    employees

    1887

    139 years old

    New York

    United States

    ₹19.1L PA avg

    Avg at Bristol-Myers Squibb

    About

    We are a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. At Bristol Myers Squibb, we work every day to transform patients’ lives through science. We combine the agility of biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation. We have the brightest people in the industry and believe that their diverse experiences and perspectives help to bring out our best ideas, drive innovation and achieve transformative business results. Each day, our employees around the world work together for patients – patients are at the center of everything we do. They inspire us. They are the reason we come to work each day. We are proud of the advancements we have made in oncology, hematology, immunology, and cardiovascular disease, and we are dedicated to helping patients prevail over serious diseases through our diverse and promising pipeline and new scientific platforms. We are pursuing therapies at the forefront of scientific discovery with the goal of bringing an exciting new generation of life-changing treatments to patients. We aspire to be at the center of a vibrant healthcare innovation ecosystem, where academic research centers, biotech, and biopharma companies all contribute to continued scientific advancement.

    Industries

    PharmaBiotech & Life sciences

    Employee ratings

    10 reviews

    3.7/ 5

    Culture

    2.6

    Career growth

    2.2

    Work-life

    3.1

    Employees rate it well for

    Work-Life Balance38Compensation & Benefits37

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    Submission Senior Specialist · waiting for your command