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    Medical Writing Asset Lead Clinpharm (Associate Director)

    Gsk Plc
    5+ years
    Not Disclosed
    Bangalore
    10 Oct. 16, 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 Description: Associate Director Medical Writing Asset Lead - ClinPharm

    Location: Mississauga Milverton Drive, Bengaluru Luxor North Tower
    Posted Date: October 11, 2024

    Job Purpose:
    Are you passionate about a medical writing role that shapes operational strategy and accelerates product approvals? If you have experience in clinical pharmacology, this Associate Director Medical Writing Asset Lead position may be the perfect opportunity for you.

    As the Associate Director Medical Writing Asset Lead, you will implement operational strategies under the guidance of the Therapeutic Area Head of Medical Writing. Your role involves tracking milestones and deliverables to manage the Medical Writing team's performance, ensuring regulatory compliance and high-quality deliverables.

    Key Responsibilities:

    • Leadership & Strategy: Lead medical writing for one or more medicines/vaccine assets, focusing on clinical pharmacology. Develop strategies for clinical program documentation.
    • Document Development: Ensure delivery of high-quality clinical documents such as study protocols, reports, briefing documents, and regulatory submissions, adhering to GSK standards and regulatory requirements.
    • Collaboration: Work closely with internal teams, CROs, and medical writers to ensure timely delivery of documents. Engage with Global Regulatory Affairs and cross-functional groups to align business needs and clinical data.
    • Performance Standards: Set and uphold high performance standards within the matrix team, ensuring alignment with portfolio strategies and submission timelines.
    • Process Improvement: Drive organizational process improvements and promote an environment for innovation and simplification. Encourage team members to challenge the status quo and explore new solutions.
    • Training & Mentorship: Develop training materials and mentor team members to share knowledge and enhance skills across the team.
    • Resource Management: Provide resourcing information to the Medical Writing Therapeutic Area Head and contribute to budget forecasts.

    Requirements:

    Basic Qualifications:

    • PhD, PharmD, MPH, MSc, or other relevant postgraduate degree.
    • 6+ years of experience in clinical regulatory writing within the pharmaceutical industry.
    • Proven track record in clinical document writing and project management.
    • Experience working with ICH/GCP guidelines.

    Preferred Qualifications:

    • Experience in immunogenicity, biomarkers, or virology.
    • Strong communication skills with the ability to present complex ideas clearly.
    • Demonstrated decision-making and problem-solving capabilities.
    • Experience in risk management and monitoring.

    Why GSK?
    At GSK, our values—Patient focus, Transparency, Respect, Integrity—are at the core of our culture. We foster a collaborative environment that encourages innovation and personal growth. If you share our ambition to improve global health, consider joining us on this exciting journey.

    Important Notice:
    GSK does not accept unsolicited referrals from employment businesses or agencies. Please be wary of fraudulent job advertisements or emails requesting payment for recruitment processes. Report suspicious communications to askus@gsk.com to verify job authenticity.

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