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    Medical Lead

    Novartis
    1-4 years years
    Preffered by Company
    Not Disclosed July 9, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm, M.Pharm, PharmD, Master’s degree in Life Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology or Biophysics) or a degree in Dentistry or Bachelor degree in Veterinary 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

    Medical Lead

    Job ID: REQ-10007090
    Posted On: July 3, 2024
    Location: India
    Division: International
    Business Unit: Innovative Medicines
    Company/Legal Entity: IN10 (FCRS = IN010) Novartis Healthcare Private Limited
    Functional Area: Research & Development
    Job Type: Full-time
    Employment Type: Regular
    Shift Work: No

    Summary

    The Medical Lead is responsible for supporting the design, implementation, and execution of Medical Affairs plans for assigned Therapy Areas. This includes providing scientific information, helping design and organize clinical studies, and building educational dialogue with Key Opinion Leaders (KOLs) and regulatory stakeholders.

    Key Responsibilities

    • Support Strategy: Align country medical affairs strategy with global strategy, country insights, and market conditions. Implement Medical Affairs activities within designated therapy areas.
    • Scientific Meetings: Coordinate scientific meetings, symposia, congresses, Continuous Medical Education (CME), and other medical/scientific exchange activities. Develop engagement plans for country customer-facing activities and ensure timely execution.
    • Inquiry Response: Ensure quality and timely responses to inquiries. Establish response documents for frequently asked questions.
    • Clinical Trials: Provide medical/scientific input into the development and execution of clinical trial or research activities. Support country strategy for Non-Interventional Studies (NIS) and Investigator Initiated Trial activities.
    • Material Review: Coordinate review and approval of medical and promotional materials. Tailor global or regional medical materials for local needs, ensuring compliance with local/P3 guidelines.
    • Cross-Functional Insights: Provide medical insights to cross-functional groups, including Pharmacovigilance, Regulatory Affairs, Market Access, QA, Commercial and Brand teams.
    • Risk Management: Identify and assess risks, plan mitigations, and monitor internal controls within the area of responsibilities.

    Essential Requirements

    • Education: MBBS; MD mandatory with a minimum of 1+ year industry experience.
    • Skills:
      • Operations Management and Execution Project Management
      • Collaborating across boundaries
      • Clinical Trial Design, Data & Reporting
      • Medical Science and Disease Area Knowledge
      • Medical Education and Scientific Engagement
      • Non-Interventional Studies (NIS) / Epidemiology Studies
      • Medical Governance and Medical Safety

    Desirable Requirements

    • Experience in the Cardiovascular therapeutic area.

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