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    Senior Specialist, Medical Affairs

    Organon
    2+ years
    Not Disclosed
    Tokyo
    10 Nov. 15, 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 Description

    Position: Medical Services Sr. Specialist

    Overview:
    The Medical Services Sr. Specialist is responsible for triaging and responding to all medical inquiries from healthcare providers and other stakeholders. This role ensures high-quality medical communications and manages processes related to promotional review, upholding the highest standards in medical services.

    Key Responsibilities:

    • Medical Information:

      • Respond to unsolicited on-label and off-label inquiries from healthcare providers and other stakeholders.
      • Ensure responses are professional, high-quality, and scientifically accurate.
      • Collaborate with Medical Advisors and Medical Science Liaisons to create standardized answers for routine inquiries.
      • Research, assess, and compile responses from both published and unpublished literature to provide clinical support.
      • Report adverse events and product quality complaints to the appropriate departments.

    • DPOC Process Management:

      • Ensure proper receipt, classification, and routing of product inquiries to meet regulatory and business needs.
      • Maintain accurate records in the DPOC database.
      • Generate and report monthly key performance metrics for DPOC.
      • Identify gaps in the medical information process and resolve them promptly.
      • Provide training and support to Medical Advisors, Medical Science Liaisons, and other staff on managing DPOC inquiries.

    • Medical Review:

      • Oversee the review and approval of promotional materials, ensuring they meet company policies and local regulations before public release.
      • Provide leadership and training to country staff on promotional material review processes.
      • Stay informed on regulations and laws governing promotional materials.

    Required Experience and Skills:

    • Minimum 3 years of pharmaceutical experience, with preference given to those with experience in medical information, contact centers, or medical review.
    • Experience with women's health-related products is preferred.
    • Strong ethical integrity and responsibility for meeting response deadlines.
    • Excellent communication, collaboration, and organizational skills.
    • Understanding of domestic regulations and industry codes related to medical information and promotional materials.
    • Proficient in the use of medical literature systems and tools.
    • Fluent in English (business level).

    About Us:
    Organon is a global healthcare company dedicated to improving the lives of women and their families. With a portfolio focused on Women's Health, we aim to address unmet healthcare needs and expand access to biosimilars, offering a diverse range of health solutions. Our vision is to improve the health of communities around the world by empowering women.

    Employment Details:

    • Employee Status: Project Temp (Fixed Term)
    • Relocation: No relocation
    • Visa Sponsorship: Not offered
    • Travel Requirements: Must meet travel and credentialing requirements.
    • Flexible Work Arrangements: Available

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