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    Senior Medical Regulatory Writer

    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: Senior Medical Regulatory Writer
    Hiring Manager: Head of Scientific Communications / Team Lead
    Location: Hyderabad
    Travel Requirements: As per business need
    Job Type: Permanent, Full-Time

    About the Job

    Our Team:

    Sanofi Global Hub is an internal resource organization based in India, dedicated to centralizing processes and activities that support Specialty Care, Vaccines, General Medicines, CHC, CMO, R&D, Data & Digital functions. We aim to be a strategic partner for Medical, HEVA, and Commercial organizations globally.

    Main Responsibilities:

    • Write and edit high-quality safety and clinical documents, including medical sections of Periodic Benefit-Risk Evaluation Reports (PBRER), Clinical Study Reports (CSR), and clinical evaluation reports.
    • Ensure timely delivery of documents that comply with both internal and external standards and guidelines.
    • Work independently on documents with minimal supervision while mentoring junior medical writers and conducting efficient peer reviews.

    Essential Duties:

    1. Participate independently in planning analyses and data presentations, collaborating with mentoring medical writers as needed.
    2. Develop and maintain therapeutic area (TA) expertise.
    3. Review content produced by peer writers.
    4. Collaborate effectively with Scientific Communication, Medical Regulatory Writing, Pharmacovigilance, and Corporate Affairs teams.

    People Responsibilities:

    • Build effective relationships with stakeholders in the medical scientific community within the assigned Global Business Unit.
    • Interact productively with medical and pharmacovigilance departments.
    • Assist other medical regulatory writers in developing their knowledge and expertise.

    Performance Responsibilities:

    • Deliver documents such as PBRERs, CSRs, Product ID Cards, and clinical evaluation reports according to agreed timelines and quality standards.

    Process Responsibilities:

    1. Author and review documents, acting as an expert in medical regulatory writing while ensuring compliance with regulatory requirements.
    2. Assist medical teams in conducting comprehensive regulatory writing needs analyses.
    3. Implement key elements of the medical regulatory plan for the identified region.
    4. Collaborate with selected vendors to deliver required documents as per established processes.
    5. Design action plans based on customer feedback to enhance content and delivery.
    6. Prepare and review standby statements and Q&A documents for managing Product Alerts.
    7. Track, file, and archive materials to ensure audit readiness.
    8. Stay updated on Sanofi Policy and Quality Document developments.

    Stakeholder Responsibilities:

    • Work closely with Clinical and Medical teams to identify writing needs and assist in developing deliverables.
    • Proactively liaise with various departments to prepare relevant and customized 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, excellent communication skills, and the ability to work both independently and collaboratively.

    Technical Skills:

    • Proficient in medical operational excellence, time and risk management, and skilled in technical editing and writing. Familiarity with data retrieval, scientific data interpretation, and knowledge of ICH and GCP/GVP guidelines is essential.

    Education:

    • Advanced degree in life sciences, pharmacy, or a similar discipline (PhD, Master's, or Bachelor's) or a medical degree (MBBS, BDS, BAMS, BHMS, MD).

    Languages:

    • Excellent command of the English language (spoken and written).

    Pursue Progress. Discover Extraordinary.

    At Sanofi, we believe that progress comes from diverse individuals united by a shared goal of making miracles happen. Join us in this mission.

    We are committed to providing equal opportunities to all, regardless of race, gender, or background.

    Watch our One Day at Sanofi video and explore our Diversity, Equity, and Inclusion initiatives at sanofi.com. Together, let’s pursue progress and discover extraordinary!

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