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    Senior Medical Regulatory Writer

    Sanofi
    5+ years
    Not Disclosed
    Hyderabad Mumbai
    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: Medical Regulatory Writer
    Grade: NA
    Hiring Manager: Head of Scientific Communications / Team Lead
    Location: Hyderabad / Mumbai
    Travel Requirements: As per business needs
    Job Type: Permanent, Full-Time

    About the Job

    Our Team:

    Sanofi Global Hub is an internal resource organization based in India, focused on centralizing processes to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. We strive 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 meet internal and external standards and guidelines.
    • Work independently with minimal supervision while mentoring junior medical writers and conducting peer reviews.

    Essential Duties:

    1. Independently participate in planning analysis and data presentation alongside mentoring medical writers.
    2. Develop and maintain therapeutic area expertise.
    3. Review content created by peer writers.
    4. Collaborate effectively with Scientific Communication teams, Medical Regulatory Writing teams, Pharmacovigilance teams, and Corporate Affairs teams.

    People Responsibilities:

    • Maintain effective relationships with stakeholders in the medical scientific community within the allocated Global Business Unit.
    • Interact efficiently with medical and pharmacovigilance departments.
    • Assist other medical regulatory writers in developing knowledge and sharing 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 as an expert in medical regulatory writing, ensuring compliance with regulatory requirements.
    2. Assist the medical team in conducting comprehensive writing needs analyses.
    3. Implement elements of the medical regulatory plan for the region.
    4. Collaborate with vendors to deliver required documents as per established processes.
    5. Design action plans based on customer feedback to improve content and delivery.
    6. Prepare and review standby statements and Q&A documents as part of managing Product Alerts.
    7. Track and archive materials to ensure audit readiness.
    8. Stay updated on Sanofi Policy and Quality Document developments.

    Stakeholder Responsibilities:

    • Work closely with Clinical/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 regulatory writing experience in the pharmaceutical or healthcare industry.

    Soft Skills:

    • Strong stakeholder and vendor management, communication skills, and ability to work independently and in teams.

    Technical Skills:

    • Proficiency in medical operational excellence, time and risk management, excellent medical editing and writing skills, and data interpretation.

    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 happens through diverse individuals from various backgrounds, united by a desire to make 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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