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    Medical Writing

    Tata Consultancy Services
    0-2 years
    Not Disclosed
    Mumbai
    10 Feb. 6, 2025
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm 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

    Here’s the rewritten job description with a unique slug at the end:

    Medical Writing Role – Tata Consultancy Services, Mumbai, India

    Job Description:
    Tata Consultancy Services (TCS) is hiring for a Medical Writing role!

    Responsibilities:

    • Define, discuss, and align expectations for clinical documents during kickoff and follow-up meetings.
    • Lead the authoring and editing of clinical documents while ensuring adherence to regulatory guidelines, timelines, and applicable standards.
    • Conduct quality reviews of clinical documents within defined timelines, following established templates and guidelines.
    • Communicate effectively with internal and external stakeholders, including authors and key opinion leaders, to resolve issues and ensure clarity.
    • Stay updated on project status, clinical operating plans, ongoing/new studies, and relevant scientific literature.
    • Maintain and develop expertise in regulatory guidelines, technological advancements, and industry standards.
    • Train and mentor new and existing medical writers.
    • Oversee live projects handled by new medical writers and provide necessary guidance.

    Additional Responsibilities (Documentation Lead Role, if assigned):

    • Lead PDRD deliverables for projects, acting as the primary point of contact for content/document preparation.
    • Ensure alignment and content reusability across documents for a product.
    • Guide document writers on content alignment and timeline management.
    • Provide source documents, study documentation details, and relevant project contacts.
    • Participate actively in Regulatory Affairs Functional or other cross-functional team meetings.
    • Review document content before finalization to ensure high quality before expert or author review.

    Desired Candidate Profile:
    Qualifications:

    • Bachelor's Degree: Pharmacy (B.Pharm), Science (B.Sc)
    • Master's Degree: Science (M.Sc), Applied Physics (M.Sc Applied Physics)

    Location: Mumbai, India

     

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