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    Global Medical Expert

    Sanofi
    5+ years
    Not Disclosed
    Hyderabad
    10 Oct. 17, 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 Title: Global Medical Expert
    Grade: NA
    Hiring Manager: Head of Scientific Communications / Team Lead
    Location: Hyderabad / Mumbai
    Travel Requirements: As per business needs
    Job Type: Permanent, Full-Time

    About the Job

    Our Team:

    Sanofi Business Operations is an internal organization based in India, focused on centralizing processes to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. We aim to be a strategic partner for Medical, HEVA, and Commercial organizations globally.

    Main Responsibilities:

    • Collaborate with a team of medical regulatory writers of varying expertise levels.
    • Develop expertise in medical regulatory writing, ensuring compliance with regional regulatory requirements (FDA, EU, etc.).
    • Coordinate medical activities related to maintaining marketing authorizations for Established and Generic products across various therapeutic areas.
    • Work closely with Global Medical Leads, Global Regulatory Affairs, Global Pharmacovigilance, and external vendors.

    Essential Duties:

    1. Provide medical assessments using updated clinical evidence and oversee strategic documents such as PBRERs, ACOs, DSURs, and more.
    2. Draft extended study synopses in collaboration with RWE experts and ensure compliance with SOP, GCP, and regulations.
    3. Write key medical and clinical sections of Common Technical Documents (CTD) and Briefing Packages (BP).
    4. Review and approve compassionate use requests for Sanofi products in critical situations.
    5. Ensure timely delivery of high-quality medical documents that meet internal and external standards.
    6. Collaborate effectively with stakeholders, including global medical leads and pharmacovigilance teams.

    People Responsibilities:

    • Maintain effective relationships with stakeholders in the medical, regulatory, and pharmacovigilance communities.
    • Interact efficiently with medical and pharmacovigilance departments.
    • Assist the medical regulatory writing team in knowledge development and expertise sharing.

    Performance Responsibilities:

    • Ensure timely support for deliverables like PBRERs, ACOs, and Investigator brochures, adhering to agreed timelines and quality standards.

    Process Responsibilities:

    • Provide medical strategic insights related to Sanofi’s portfolio.
    • Contribute to the management of marketing authorization dossiers.
    • Serve as a regulatory writing expert, maintaining requirements for supported countries and teams.
    • Assist the medical team in conducting comprehensive writing-needs analyses.

    Stakeholder Responsibilities:

    • Collaborate with regional medical teams to identify writing needs and assist in developing deliverables.
    • Liaise with the Medical department to ensure tailored solutions are delivered as expected.

    About You

    Experience:

    • Minimum 5 years in medical affairs, clinical development, or pharmacovigilance within international pharmaceutical companies, with expertise in at least one therapeutic area (e.g., cardiovascular, oncology).

    Soft Skills:

    • Strong stakeholder management, communication skills, and the ability to work independently and in a team.

    Technical Skills:

    • Proficiency in medical operational excellence, time and risk management, and exceptional medical editing and writing skills.

    Education:

    • Medical degree (MBBS or MD).

    Languages:

    • Excellent command of spoken and written English.

    Pursue Progress, Discover Extraordinary

    At Sanofi, we believe in better medications, better outcomes, and better science. Progress requires diverse individuals from various backgrounds, united by a common goal: to make miracles happen. Join us in this mission.

    We are committed to providing equal opportunities to all, regardless of race, gender, or background.

    Watch our ALL IN video and explore our Diversity, Equity, and Inclusion initiatives at sanofi.com. Together, let’s pursue progress and discover extraordinary!

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