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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, based in India, is a centralized resource organization that supports a wide range of Sanofi’s business functions including Specialty Care, Vaccines, General Medicines, CHC, CMO, R&D, and Data & Digital. The hub plays a key role in providing strategic and functional support for global teams in Medical, HEVA, and Commercial sectors.

    Main Responsibilities
    As a Medical Regulatory Writer, your responsibilities will include:

    • Document Creation and Editing:

      • Writing and editing high-quality safety and clinical documents such as Periodic Benefit-Risk Evaluation Reports (PBRER), Clinical Study Reports (CSR), Addendum to Clinical Overviews, Disease and Product ID Cards, Clinical Evaluation Reports, and trial transparency documents.
      • Ensuring all documents meet internal and external quality, compliance, and timeline standards.
      • Working independently with minimal supervision while acting as a mentor to junior medical writers and conducting efficient peer reviews.

    • Collaboration and Expertise:

      • Participate in the planning and data presentation for medical writing, collaborating with peers and teams.
      • Maintain and develop therapeutic area (TA) expertise to ensure high-quality deliverables.
      • Review content developed by other writers and contribute to the development of best practices within the team.
      • Collaborate effectively with global or local scientific communication, medical regulatory writing, pharmacovigilance, and regulatory teams.

    • Performance and Stakeholder Engagement:

      • Manage the delivery of medical regulatory documents (PBRER, CSR, Product Alerts, etc.) according to agreed timelines and quality standards.
      • Work closely with stakeholders to develop relevant medical regulatory content as per product and business needs.
      • Interact with the medical and pharmacovigilance teams to ensure the preparation of accurate and timely documentation.

    • Process Management and Reporting:

      • Author and review medical regulatory content in compliance with regulatory requirements for supported regions.
      • Assist in conducting medical regulatory writing needs analysis for the assigned teams.
      • Collaborate with vendors and teams to deliver medical regulatory documentation following defined processes.
      • Track postings, file materials in relevant systems, and maintain audit and inspection-readiness.
      • Stay up-to-date with changes in Sanofi policy and quality documents.

    • Stakeholder Management:

      • Engage with Clinical, Medical, Pharmacovigilance, Biostatistics, Regulatory, Legal, and Corporate Affairs teams to prepare customized deliverables.
      • Liaise with global/local teams to ensure timely development of necessary documentation.

    About You

    • Experience: Over 5 years of experience in regulatory writing within the pharmaceutical or healthcare industry.
    • Soft Skills: Excellent stakeholder management, communication skills, and the ability to work independently or as part of a team.
    • Technical Skills: Strong editing and writing skills with a deep understanding of medical operational excellence. Familiarity with data interpretation, scientific literature screening, ICH, GCP/GVP guidelines, and regulatory writing. Proficient in relevant computer applications.
    • Education: Advanced degree in life sciences, pharmacy, or related disciplines (PhD, Master’s, or Bachelor’s in Science, D Pharma, PharmD), or a medical degree (MBBS, MD, BDS, BHMS, BAMS).
    • Languages: Excellent proficiency in English (spoken and written).

    Why Choose Us?
    At Sanofi, we are driven by the belief that progress doesn’t happen alone—it’s built by diverse people united by a common goal: making the impossible possible. Join us in our mission to advance science, improve health outcomes, and create better medicines.

    Sanofi is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees, regardless of race, color, gender, sexual orientation, disability, or other protected characteristics.

    Watch our ALL IN video and learn more about our Diversity, Equity, and Inclusion initiatives at sanofi.com.

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