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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, serves as a centralized resource organization that supports key functions within Sanofi, including Specialty Care, Vaccines, General Medicines, CHC, CMO, R&D, and Data & Digital. The hub is integral in providing strategic and functional support to the global Medical, HEVA, and Commercial teams, ensuring timely and high-quality deliverables.

    Main Responsibilities
    As a Medical Regulatory Writer, your role will encompass the following:

    • Document Creation and Editing:

      • Author and edit high-quality safety and clinical documents, including Periodic Benefit-Risk Evaluation Reports (PBRER), Clinical Study Reports (CSR), Addenda to Clinical Overviews, Disease and Product ID Cards, Clinical Evaluation Reports, and trial transparency documents.
      • Ensure timely delivery of documents in compliance with internal and external standards.
      • Work independently on documents with minimal supervision, while mentoring junior medical writers and providing peer reviews.

    • Collaboration and Expertise:

      • Contribute to the planning of analysis and data presentation for medical documents, collaborating with mentoring medical writers.
      • Develop and maintain therapeutic area (TA) expertise to enhance the quality of content produced.
      • Review documents created by peers and assist in refining and enhancing their content.
      • Collaborate with global or local Scientific Communication, Medical Regulatory Writing, Pharmacovigilance, Regulatory, and Corporate Affairs teams.

    • Stakeholder Management:

      • Maintain effective relationships with stakeholders within the medical scientific community to develop and deliver medical regulatory content tailored to the business needs.
      • Proactively collaborate with medical, pharmacovigilance, clinical, biostatistics, regulatory, legal, and corporate affairs teams to prepare and customize documents as needed.
      • Assist junior medical regulatory writers in developing their skills and sharing expertise within the team.

    • Performance and Process Management:

      • Provide deliverables such as PBRERs, ACOS, CSRs, product alerts, and study results as per the established timelines and quality standards.
      • Collaborate with vendors and internal teams to ensure all deliverables align with regulatory and internal processes.
      • Track postings, ensure archiving of materials in relevant systems, and maintain inspection readiness.
      • Keep abreast of policy changes and updates to Sanofi’s Quality Documents.

    About You

    • Experience: Over 5 years of experience in regulatory writing within the pharmaceutical or healthcare industry.
    • Soft Skills: Strong stakeholder management, vendor management, excellent communication, and the ability to work both independently and collaboratively.
    • Technical Skills: Advanced medical editing and writing skills, knowledge of ICH, GCP/GVP, scientific data interpretation, and ability to tailor content for specific audiences.
    • Education: Advanced degree in life sciences, pharmacy, or a related discipline (PhD, Master's, or Bachelor’s in Science, D Pharma, PharmD) or a medical degree (MBBS, BDS, BHMS, MD).
    • Languages: Proficient in English (reading, writing, and speaking).

    Why Join Us?
    At Sanofi, we believe progress is made by people—people from diverse backgrounds, in various roles, working together towards the common goal of making the impossible possible. Join us in our mission to make a meaningful difference in healthcare by advancing science, improving health outcomes, and creating innovative medicines.

    Sanofi is committed to providing equal opportunities to all employees, regardless of race, color, gender, sexual orientation, disability, or any other protected characteristic.

    Explore our commitment to Diversity, Equity, and Inclusion in the workplace by visiting our website at sanofi.com.

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