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    Global Medical Expert

    Sanofi
    2+ years
    Not Disclosed
    Hyderabad
    10 Nov. 7, 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

    Global Medical Expert

    Location: Hyderabad / Mumbai, India
    Job Type: Permanent, Full-Time
    Travel Requirement: As per business need

    About Us

    At Sanofi Business Operations, our mission is to centralize and streamline operations across Specialty Care, Vaccines, General Medicines, Consumer Healthcare (CHC), Contract Manufacturing (CMO), and R&D functions. We provide strategic support to Medical, HEVA, and Commercial teams, empowering Sanofi’s global operations to drive innovation and deliver results.

    As a Global Medical Expert, you will play a critical role in supporting medical and regulatory writing activities for Sanofi’s product portfolio, including therapeutic areas such as cardiovascular, diabetes, CNS, oncology, and more. You’ll collaborate with global teams to develop high-quality medical content, ensuring regulatory compliance across markets and contributing to the marketing authorization of our products.

    Key Responsibilities

    Medical Writing & Regulatory Content

    • Lead medical assessments and ensure the execution of key regulatory documents such as PBRERs, ACO, DSURs, clinical overviews, and benefit-risk assessments for the assigned therapeutic areas or products.
    • Collaborate with RWE experts to draft extended synopses of studies and oversee their execution, ensuring compliance with SOP, GCP, and regulatory standards.
    • Write and review critical medical/clinical content for Common Technical Documents (CTD), briefing packages, and other regulatory submissions.
    • Support the compassionate use of Sanofi products for serious or life-threatening diseases and ensure compliance with medical and regulatory standards.
    • Ensure timely and high-quality delivery of medical documents in compliance with internal and external standards.

    Collaboration & Stakeholder Engagement

    • Engage with global medical leads, regulatory affairs teams, and pharmacovigilance departments to ensure the development of accurate and relevant medical regulatory content.
    • Work closely with vendors and operational teams to ensure timely and compliant delivery of documents.
    • Maintain effective relationships with stakeholders in medical, regulatory, and pharmacovigilance functions.
    • Assist in the development of knowledge within the medical regulatory writing team, providing mentorship and sharing expertise.

    Strategic Insights & Process Leadership

    • Provide medical strategic insights and evaluations related to Sanofi’s portfolio, contributing to the management of marketing authorization dossiers.
    • Contribute to the development and implementation of medical regulatory plans, ensuring the successful execution of medical writing needs.
    • Assist the Head of Scientific Communications in designing plans for continuous improvement based on feedback from end-customers.
    • Ensure the highest quality standards and compliance in the development of all deliverables.

    About You

    Experience

    • 5+ years of experience in medical affairs, clinical development, or pharmacovigilance with a focus on regulatory writing for international pharmaceutical companies.
    • Proven experience in at least one therapeutic area, including cardiovascular, metabolism, oncology, CNS, diabetes, or anti-infectives.

    Skills

    • Strong stakeholder management and communication skills.
    • Ability to work independently and collaborate effectively in team environments.
    • Excellent medical writing and editing skills with a focus on regulatory documentation.
    • Strong time management and risk management skills to ensure timely, high-quality deliveries.

    Education

    • Medical degree (e.g., MBBS, MD) or equivalent.
    • Excellent command of the English language (spoken and written).

    Why Sanofi?

    At Sanofi, we are committed to transforming healthcare and empowering individuals globally. Our diverse teams work together across functions and locations, united by a passion for improving health outcomes and driving innovation. By joining us, you’ll have the opportunity to make an impact, develop professionally, and contribute to meaningful change in the healthcare industry.

    What We Offer:

    • A collaborative, inclusive environment where you can make a difference.
    • Competitive compensation and a comprehensive benefits package.
    • The chance to be part of a company that’s making a real difference in the world of healthcare.

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