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    Associate Regulatory Affairs Officer

    Iqvia
    0-5 years
    Preffered by Company
    Bangalore
    10 Sept. 3, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any LifeScience Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, 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

    Position: Junior Publisher

    Job Overview:

    The Junior Publisher plays a crucial role in supporting the compilation, publishing, and technical quality control of regulatory submissions. This position involves handling the collection of components, assembling dossiers, performing quality reviews, and delivering submissions in both paper and electronic formats (such as NeeS and eCTD). The Junior Publisher will assist in creating and managing electronic submissions, ensure compliance with Health Authority (HA) guidelines, and support the collection of CSR appendices. This role also includes interacting with internal and occasionally external clients, managing daily tasks, and staying updated on relevant trends and regulatory guidelines.

    Key Responsibilities:

    • Regulatory Submissions:

      • Support the compilation, publishing, and technical quality control of regulatory submissions.
      • Manage the collection of components, assembly, and quality review of dossiers in paper and electronic formats (e.g., NeeS, eCTD).

    • Electronic Submissions:

      • Assist with electronic submissions, including bookmarking, hyperlinking, and creating tables of contents in accordance with Health Authority guidelines.

    • Documentation and Coordination:

      • Support the collection of CSR appendices in line with ICH guidelines and IQVIA’s standard practices, with guidance from the lead medical writer.
      • Interact with internal clients and, occasionally, external stakeholders as directed by senior staff.

    • Work Management:

      • Take responsibility for managing day-to-day tasks and workload, ensuring timely completion and high-quality output.
      • Stay informed about current trends and advancements in drug development, medical writing, and regulatory submissions.

    • Compliance and SOPs:

      • Adhere to Company SOPs and participate in the implementation of new SOPs.

    Required Knowledge, Skills, and Abilities:

    • Regulatory Knowledge:

      • Basic understanding of clinical research regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines, or the ability to acquire this knowledge.

    • Communication and Organization:

      • Strong verbal, written, and aural communication skills.
      • Excellent organizational and time management skills.

    • Technical Proficiency:

      • Proficiency in Microsoft Office and web-based applications.
      • Attention to detail and accuracy, with the ability to maintain high-quality standards.

    • Work Ethic:

      • Ability to follow instructions and guidelines, utilize initiative, and work independently.
      • Proven capability to manage multiple tasks, competing priorities, and meet deadlines.
      • Willingness to learn new skills and adapt as needed.
      • Self-motivated and flexible approach to work.

    Minimum Required Education and Experience:

    • Bachelor’s degree in a life science-related discipline is preferred.
    • Understanding of Regulatory Affairs and Publishing is advantageous.

    About IQVIA:

    IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments, aiming to improve patient outcomes and population health worldwide. For more information about our career opportunities, visit IQVIA Careers.

     

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