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    Principal Medical Writer

    Gsk Plc
    10-12 years
    Not Disclosed
    Bangalore
    10 Dec. 20, 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, 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

    Job Title: Principal Medical Writer
    Location: Bengaluru Luxor North Tower, Bengaluru
    Posted Date: Dec 17, 2024
    Experience Required: 10 - 12 Years

    Job Purpose:
    We are looking for a Principal Medical Writer with extensive expertise in clinical and regulatory document writing. The role involves independently executing complex writing assignments related to clinical trials and regulatory submissions, including the preparation of clinical study reports (CSR), briefing documents, and other essential clinical documentation. You will be responsible for ensuring the accuracy and quality of documents while coordinating and collaborating with various stakeholders.

    Key Responsibilities:

    • Lead the writing of clinical regulatory documents including protocols, clinical study reports (CSRs), NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions.
    • Collaborate within a matrix team to deliver high-quality clinical documents that meet GSK standards and comply with global, regional, and local regulatory requirements.
    • Act as a significant contributor in the preparation and production of clinical dossier documents for regulatory submissions worldwide.
    • Manage projects of increasing scope and complexity effectively.
    • Understand interdependencies among functions such as clinical pharmacology, biomarkers, and health outcomes.
    • Analyze complex clinical data and translate it into clear, concise reports.
    • Assess trends and patterns in text and data, ensuring content is organized effectively in clinical reports and summary documents.
    • Provide input on the content and display of tables in reporting and analysis plans.
    • Use document preparation tools and automation techniques to streamline processes.
    • Adapt to changing environments and prioritize tasks based on shifting requirements.
    • Maintain effective oral and written communication with internal and external stakeholders.

    Education and Experience Requirements:

    • PhD or equivalent relevant experience within the life sciences space.
    • Clinical regulatory writing experience in the pharmaceutical industry.
    • Proven leadership and experience in multicultural settings.
    • Ability to interpret, describe, and document clinical data effectively.
    • In-depth knowledge of International Committee for Harmonisation (ICH) and Good Clinical Practice (GCP).
    • Strong computer literacy and excellent English language skills (verbal and written).

    Why GSK?
    At GSK, we unite science, technology, and talent to advance healthcare and improve the lives of billions. We focus on four core therapeutic areas: infectious diseases, HIV, respiratory/immunology, and oncology. As a global biopharma company, we are committed to making GSK a place where everyone can thrive—where you are valued, inspired, and supported to reach your full potential. Join us in this exciting journey to get Ahead Together.

    Important Notice to Employment Businesses/Agencies:
    GSK does not accept referrals from employment businesses or agencies without prior written authorization. Unauthorized referrals will not be compensated.

    Important Recruitment Notice:
    GSK does not charge any fees for recruitment. If you encounter fraudulent job advertisements or emails requesting payments, please inform us at askus@gsk.com.

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