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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, India
    Category: Medical and Clinical
    Job ID: 411549
    Posted Date: Dec 17, 2024
    Years of Experience: 10 - 12 years

    Job Purpose:
    The Principal Medical Writer is a highly skilled professional responsible for independently executing complex writing assignments related to clinical trial designs and the interpretation of statistically analyzed research data. This role involves drafting, reviewing, and approving clinical documents, including marketing application submission documents. The position requires extensive expertise in clinical document writing, as well as the ability to plan, prioritize, and contribute to continuous improvement initiatives in clinical writing practices.

    Key Responsibilities:

    • Write and review complex clinical regulatory documents, including protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions.
    • Collaborate in a matrix team to ensure high-quality, fit-for-purpose clinical documents that reflect associated data and comply with GSK standards and regulatory requirements.
    • Contribute significantly to planning and producing clinical dossier documents for global regulatory submissions.
    • Manage projects of increasing scope and complexity, demonstrating effective time management and problem-solving skills.
    • Assess trends and patterns in clinical data and organize content for clear presentation in reports.
    • Review reporting and analysis plans, providing critical input on the content and format of tables.
    • Utilize document preparation tools and automation to streamline workflows.
    • Adapt to support documents across various therapeutic areas.

    Education and Experience Requirements:

    • PhD or relevant working experience in the life sciences.
    • Significant experience in clinical regulatory writing in the pharmaceutical industry.
    • Leadership experience, particularly in multicultural settings and with remote teams.
    • In-depth understanding of ICH/GCP guidelines and the ability to interpret and document clinical data.

    Skills and Competencies:

    • Expertise in writing clinical regulatory documents, with a proven track record.
    • Strong technical, statistical, and computer skills, with the ability to interpret complex clinical data.
    • Excellent written and verbal communication skills.
    • Ability to prioritize tasks effectively and work independently.

    Why GSK?
    GSK is a global biopharma company focused on using science, technology, and talent to get ahead of disease and positively impact the health of billions. GSK fosters a culture where people thrive, grow, and can contribute to solving global health challenges. We are committed to diversity, inclusion, and creating an environment where everyone can be themselves.

    Important Notice:
    GSK does not charge fees for recruitment and advises candidates to report any suspicious job postings or emails to askus@gsk.com.

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