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    Senior Medical Regulatory Writer

    Sanofi
    5+ years
    Not Disclosed
    Hyderabad
    10 Aug. 13, 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

    Our Team:

    Sanofi Global Hub is a centralized internal resource organization based in India, designed to streamline processes and support various functions, including Specialty Care, Vaccines, General Medicines, CHC, CMO, R&D, and Data & Digital. Our mission is to be a strategic partner, providing tactical delivery services to Sanofi’s Medical, HEVA, and Commercial teams globally.

    Main Responsibilities:

    • Medical Writing and Editing: Develop and edit high-quality safety and clinical documents, including Periodic Benefit-Risk Evaluation Reports (PBRER), Addendum to Clinical Overviews (ACO), Clinical Study Reports (CSR), Disease and Product ID Cards, Clinical Evaluation Reports, Product Alerts, and Trial Transparency Documents. Ensure all documents meet internal and external standards and guidelines, and are delivered on time.

    • Mentorship and Peer Review: Work independently on document creation, providing minimal supervision. Act as a mentor or buddy to medical writers and conduct efficient peer reviews.

    Essential Job Duties and Responsibilities:

    1. Independent Planning: Participate in the planning of data analysis and presentation, initially in collaboration with a mentoring medical writer, and gradually taking on independent responsibility.
    2. TA Expertise Development: Continuously develop and maintain Therapeutic Area (TA) expertise.
    3. Content Review: Review and provide feedback on content created by peers.
    4. Collaboration: Work closely with global and local teams in Scientific Communications, Medical Regulatory Writing, Pharmacovigilance, Regulatory Affairs, and Corporate Affairs to ensure the accurate and timely delivery of assigned documents.

    People:

    • Stakeholder Relationships: Maintain strong relationships with medical and scientific stakeholders within the allocated Global Business Unit and product teams to develop required medical regulatory content.
    • Cross-functional Interaction: Collaborate effectively with stakeholders in medical, pharmacovigilance, and other related departments.
    • Knowledge Sharing: Actively assist other medical regulatory writers in knowledge development and expertise sharing.

    Performance:

    • Deliverables: Provide high-quality deliverables such as PBRER, ACO, CSR, Product and Disease ID Cards, Clinical Evaluation Reports, and other regulatory documents within agreed timelines.
    • Product Alerts Management: Manage Product Alerts, including the preparation/review of Stand-by Statements and Q&A documents.
    • Regulatory Posting: Ensure accurate posting of trial information on relevant websites, maintaining audit and inspection readiness.

    Process:

    1. Regulatory Compliance: Author and review documents, ensuring they meet the regulatory requirements for the supported countries.
    2. Needs Analysis: Assist in conducting a comprehensive medical regulatory writing needs analysis.
    3. Plan Implementation: Implement elements of the medical regulatory plan and activities for the region.
    4. Vendor Management: Collaborate with regional vendors to deliver required outputs as per defined processes.
    5. Continuous Improvement: Design action plans based on customer feedback to improve content and delivery.
    6. Document Management: Track and archive materials in relevant systems, ensuring compliance with Sanofi policies and quality documents.

    Stakeholders:

    • Collaboration: Work closely with Clinical, Medical, Pharmacovigilance, Biostatistics, Regulatory, Legal, and Corporate Affairs teams to identify and address medical writing needs.
    • Proactive Engagement: Actively engage with stakeholders to ensure the timely and customized delivery of documents.

    About You:

    • Experience: Over 5 years of experience in regulatory writing within the pharmaceutical or healthcare industry.
    • Soft Skills: Strong stakeholder and vendor management skills, excellent communication abilities, and the capacity to work both independently and within a team.
    • Technical Skills: Proficiency in medical operational excellence, time and risk management, technical writing and editing, data retrieval, scientific data interpretation, and knowledge of ICH and GCP/GVP guidelines. Expertise in summarizing scientific information and tailoring content for specific audiences. Competency in relevant computer applications.
    • Education: Advanced degree in life sciences, pharmacy, or a related discipline (PhD, Masters, Bachelor's in Science, D Pharma, PharmD) or a medical degree (MBBS, BDS, BAMS, BHMS, MD).
    • Languages: Fluent in English, with excellent reading, writing, and speaking skills.

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