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    Global Medical Expert

    Sanofi
    1-5 years
    Not Disclosed
    Hyderabad
    10 May 2, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Global Medical Expert
    Hiring Manager: Head Scientific Communications/Team Lead
    Location: Hyderabad
    % of Travel Expected: Travel required as per business need
    Job Type: Permanent and Full-time

    About the Job:
    The Global Medical Expert position at Sanofi Global Hub, based in India, plays a pivotal role in centralizing processes and activities to support various functions within Sanofi. The role involves developing medical expertise within medical regulatory writing, ensuring compliance with regulatory requirements, and coordinating medical activities related to the maintenance of marketing authorizations for Established and Generic products across different therapeutic areas. The role entails close collaboration with Global Medical Leads, Global Regulatory Affairs, Global Pharmacovigilance, and vendors.

    Main Responsibilities:

    • Provide medical assessment and oversee the execution of strategic documents such as PBRERs, ACOs, DSURs, Clinical Overviews, Benefit-Risk assessments, and more.
    • Draft extended study synopses and contribute to Common Technical Documents (CTD) or Briefing packages (BP).
    • Review and approve compassionate use requests for Sanofi medicinal products.
    • Ensure timely delivery of high-quality medical documents and collaborate effectively with stakeholders.

    People Responsibilities:

    • Maintain effective relationships with stakeholders within the allocated Global business unit and product.
    • Interact effectively with stakeholders in medical and pharmacovigilance departments.
    • Assist the medical regulatory writing team in knowledge development and expertise sharing.

    Performance Responsibilities:

    • Ensure timely delivery of supported deliverables as per agreed timelines and quality standards.
    • Contribute to the management of marketing authorization dossiers and provide medical strategic insights.

    Process Responsibilities:

    • Act as an expert in medical regulatory writing and maintain regulatory requirements.
    • Assist in conducting medical regulatory writing-needs analysis and implementing relevant elements of the medical regulatory plan.
    • Work with vendors when required and assist in designing an overall plan of action.

    Stakeholder Responsibilities:

    • Work closely with medical teams to identify writing needs and deliver assigned deliverables.
    • Liaise with the Medical department to ensure relevant and customized deliverables are met.

    About You:

    • Experience: Minimum 5 years supporting international pharmaceutical companies in medical affairs, clinical development, or pharmacovigilance.
    • Soft Skills: Strong stakeholder management and communication skills, ability to work independently and within a team.
    • Technical Skills: Medical operational excellence, time and risk management, excellent technical (medical) editing and writing skills.
    • Education: Medical degree MBBS; MD.
    • Languages: Excellent knowledge of English (spoken and written)

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