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    Senior Medical Regulatory Writer

    Sanofi
    5+ years
    Not Disclosed
    Hyderabad
    10 Dec. 10, 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

    Medical Regulatory Writer
    Location: India (Sanofi Global Hub)

    About Our Team
    Sanofi Global Hub is an internal organization within Sanofi, based in India, dedicated to centralizing processes to support various business units, including Specialty Care, Vaccines, General Medicines, CHC, CMO, R&D, Data & Digital functions. The hub serves as a strategic partner for medical, HEVA, and commercial teams, offering tactical support on a global scale.

    Main Responsibilities
    As a Medical Regulatory Writer, you will be responsible for:

    • Document Writing and Editing:

      • Write and edit high-quality safety and clinical documents, including medical sections of Periodic Benefit-Risk Evaluation Reports (PBRER), Clinical Study Reports (CSR), Disease and Product ID Cards, Clinical Evaluation Reports, and other trial transparency documents.
      • Ensure all medical regulatory documents meet internal and external standards, timelines, and guidelines.
      • Work independently with minimal supervision and act as a mentor to junior medical writers.
      • Provide expert peer reviews and collaborate on document development.

    • Collaboration and Stakeholder Engagement:

      • Maintain effective relationships with stakeholders (Medical scientific community) within the allocated Global Business Unit and product to develop required medical regulatory content.
      • Interact with stakeholders in medical, pharmacovigilance, regulatory, and other relevant departments.
      • Assist medical regulatory writers in knowledge development and sharing expertise.

    • Performance and Delivery:

      • Provide timely, high-quality deliverables, including PBRERs, Clinical Study Reports (CSRs), Product Alerts, Briefing Packages, and more.
      • Manage product alerts and trial information on websites like CT.gov, EUCTR, and others.
      • Meet deadlines for content delivery, ensuring compliance with regulatory requirements.

    • Process and Expertise:

      • Author and review medical regulatory documents while maintaining regulatory requirements for supported countries.
      • Support the medical team in conducting comprehensive medical regulatory writing needs analyses.
      • Implement elements of the medical regulatory plan and collaborate with vendors to deliver documents per the defined processes.
      • Track postings and archive materials in relevant systems to ensure audit and inspection readiness.
      • Stay updated on Sanofi’s policy changes and quality document evolution.

    • Stakeholder Management:

      • Work with Clinical, Medical, Pharmacovigilance, Biostatistics, Regulatory, and Corporate Affairs teams to develop customized deliverables.
      • Proactively liaise with internal departments to ensure that all required content is created and reviewed in line with timelines and quality expectations.

    About You

    • Experience: Over 5 years in regulatory writing in the pharmaceutical or healthcare industry.
    • Soft Skills: Excellent stakeholder management, vendor management, and communication skills; ability to work independently and in a team.
    • Technical Skills: Strong medical writing and editing skills, data interpretation, knowledge of ICH, GCP/GVP, ability to summarize scientific information for various audiences. Proficient with relevant computer applications.
    • Education: Advanced degree in life sciences, pharmacy, or related discipline (PhD, Master’s, or Bachelor’s in Science, D Pharma, PharmD), or a medical degree (MBBS, BDS, BAMS, BHMS, MD).
    • Languages: Excellent proficiency in English (written and spoken).

    Why Choose Us?
    At Sanofi, we are united by a common mission to create miracles through science. We celebrate progress and welcome diverse perspectives. Join us to work in a dynamic environment where your expertise will help us achieve better outcomes and make a difference.

    We are committed to equal opportunities for all, regardless of race, color, religion, sex, gender identity, sexual orientation, age, citizenship, marital status, disability, or other protected characteristics.

    Watch our ALL IN video and explore more about our Diversity, Equity, and Inclusion efforts on sanofi.com.

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