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    Senior Medical Information Writer

    Sanofi
    2-3 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

    Job Title: Scientific Response Writer

    Main Responsibilities:

    • Research and Documentation:
      • Conduct literature searches and reviews, extracting and summarizing complex data from scientific literature.
      • Create and maintain evidence-based, accurate, and balanced scientific response documents for products in designated therapeutic areas.
      • Adapt global scientific response documents for specific countries.
      • Develop responses to escalated inquiries from assigned countries.
      • Contribute to US NDA Annual Reports and US compendia reviews.
      • Develop and maintain expertise in relevant Therapeutic Areas.
      • Review content created by peer writers.
      • Collaborate with Global Medical Information teams to execute content plans.

    People Management:

    • Stakeholder Engagement:
      • Maintain effective relationships with end stakeholders (Medical scientific community) within the allocated Global business unit and product.
      • Interact with stakeholders in medical and pharmacovigilance departments.
      • Support other medical information writers in developing their knowledge and sharing expertise.

    Performance:

    • Deliverables:
      • Provide high-quality deliverables, including scientific response documents, US NDA Annual Reports, and US compendia reviews, within agreed timelines.

    Process:

    • Expertise and Implementation:
      • Act as an expert in medical information writing and stay updated on regulatory requirements for supported countries.
      • Assist in conducting comprehensive medical writing needs analyses.
      • Implement relevant elements of content plans and associated activities for assigned countries.
      • Collaborate with selected vendors to deliver required deliverables according to defined processes.
      • Design action plans based on customer feedback to improve content and delivery.

    Stakeholders:

    • Coordination:
      • Work closely with medical teams in regions/areas to identify medical writing needs and assist in developing deliverables.
      • Liaise with the Medical department to prepare customized deliverables.

    About You:

    • Experience:

      • Over 5 years of experience in medical writing within the pharmaceuticals or healthcare industry, or equivalent clinical experience.
      • At least 2-3 years of direct experience in medical information within a pharmaceutical company.

    • Soft Skills:

      • Effective stakeholder management and communication skills.
      • Ability to work independently and collaboratively within a team environment.

    • Technical Skills:

      • Expertise in medical operational excellence, time, and risk management.
      • Excellent technical (medical) editing and writing skills.
      • Knowledge of literature evaluation and multilevel response development.

    • Education:

      • Advanced degree in life sciences, pharmacy, or a similar discipline (e.g., PharmD, Ph.D., Master’s in Science, MBA, or equivalent).

    • Languages:

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

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