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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 resource organization in India, designed to centralize processes and activities that support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. We strive to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations globally.

    Main Responsibilities:

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

    Essential Duties:

    1. Provide medical assessments with relevant clinical evidence, overseeing strategic documents such as PBRERs, ACOs, DSURs, and more for specific therapeutic areas or products.
    2. Draft extended synopses of studies in collaboration with RWE experts, overseeing execution in compliance with SOP, GCP, and other regulations.
    3. Write key medical and clinical sections of Common Technical Documents (CTD) or Briefing Packages (BP).
    4. Review and approve compassionate use requests for Sanofi products in serious or life-threatening situations.
    5. Ensure timely delivery of high-quality medical documents that comply with internal and external standards.
    6. Collaborate effectively with stakeholders including global medical leads, regulatory affairs, medical writing teams, and pharmacovigilance teams.

    People Responsibilities:

    • Maintain effective relationships with stakeholders in the allocated Global Business Unit and products.
    • Interact efficiently with medical and pharmacovigilance departments.
    • Support the medical regulatory writing team in developing knowledge and sharing expertise.

    Performance Responsibilities:

    • Ensure timely and quality support for deliverables such as PBRERs, ACOs, CSR, Investigator brochures, and more.

    Process Responsibilities:

    • Provide medical strategic insights related to Sanofi’s portfolio.
    • Contribute to managing marketing authorization dossiers.
    • Act as a medical regulatory writing expert, maintaining regulatory requirements for supported countries and teams.
    • Conduct needs analysis for medical regulatory writing.

    Stakeholder Responsibilities:

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

    About You

    Experience:

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

    Soft Skills:

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

    Technical Skills:

    • Proficiency in medical operational excellence, time and risk management, and excellent technical (medical) editing and writing skills.

    Education:

    • Medical degree (MBBS, MD).

    Languages:

    • Excellent written and spoken English.

    Pursue Progress, Discover Extraordinary

    Better medications, better outcomes, better science—progress doesn’t happen without people. Join us in making miracles happen. At Sanofi, we are committed to diversity and equality, providing equal opportunities for all, regardless of race, gender, or background.

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

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