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    Lead - Scientific Writing

    Indegene
    6-8 years
    Not Disclosed
    Bangalore
    10 July 19, 2024
    Job Description
    Job Type: Full Time Education: MBBS/PhD/MDS/BDS/MPharm/PharmD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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 Opportunity: Lead Medical Writer

    Company: Indegene
    Location: Mumbai, India
    Type: Full-Time

    About Us:

    Indegene is a technology-led healthcare solutions provider dedicated to enabling healthcare organizations to be future-ready. We offer accelerated global growth opportunities for talent that is bold, industrious, and nimble. Join us for a unique career experience that celebrates entrepreneurship, passion, innovation, collaboration, and empathy. Explore exciting opportunities at the convergence of healthcare and technology at Indegene Careers.

    Role Purpose:

    The Lead Medical Writer is responsible for developing and reviewing medical writing deliverables that support the clinical regulatory writing portfolio and training junior writers.

    Key Responsibilities:

    • Document Preparation & Review: Prepare and review clinical study reports, protocols, investigator brochures, submission data summaries, and other regulatory documents for investigational drugs at various clinical development stages.
    • Lean Authoring: Apply lean authoring principles and structured content management text libraries as part of the authoring process.
    • Cross-Functional Team Leadership: Lead cross-functional teams to draft scientific/medical content addressing data interpretation, product claims, and internal/external queries.
    • Project Management: Develop and maintain project plans, initiate document review activities, coordinate review meetings, and ensure adherence to standard content and messaging.
    • Client Interaction: Maintain communication with the Sponsor’s Medical Writing project manager, facilitate review meetings, address feedback, and negotiate solutions.
    • Training & Mentoring: Train and mentor junior writers, provide insight, alternatives, and suggestions based on experience.
    • Regulatory Knowledge: Stay updated with regulatory guidelines/requirements and manage messaging for consistency with historical information.

    Skills & Knowledge Required:

    • Scientific Knowledge:

      • Strong knowledge of regulatory guidelines and regional requirements (e.g., EU, US).
      • Ability to interpret data and apply scientific knowledge to regulatory document writing (e.g., Investigator Brochures, protocols, amendments, Clinical Study Reports).
      • Understanding of medical practices and therapeutic areas.
      • Experience with protocols, amendments, CSR, and CTD summary documents.

    • Technology Skills:

      • Expert in MS Word, document management systems, and Word add-ins.
      • Ability to adapt to new tools and technology.
      • Experience with training writers on templates, guidelines, and tools.

    • Soft Skills:

      • Excellent communication, time management, organizational, and interpersonal skills.
      • Ability to work independently and lead document delivery under aggressive timelines.

    Qualifications:

    • Education: MBBS, PhD, MDS, BDS, MPharm, or PharmD.
    • Experience: 6 to 8 years of experience in writing clinical and regulatory documents for global filings (CTD Module 2, 4, and Module 5).

    Equal Opportunity:

    Indegene is an Equal Employment Employer committed to Inclusion and Diversity. We do not discriminate based on race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical ability, or other characteristics. All employment decisions are based on business requirements, merit, and qualifications.

    Apply Now:

    If you are excited about this opportunity, apply below to join our growing team and be at the intersection of healthcare and technology.

    Apply Here

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