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    Senior Specialist, Medical Affairs

    Organon
    3+ years
    Not Disclosed
    Tokyo
    10 Nov. 24, 2024
    Job Description
    Job Type: Full Time Remote Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

    The job description is for a Medical Services, Senior Specialist at Organon. The role focuses on responding to medical inquiries, managing promotional material reviews, and ensuring compliance with medical and scientific standards. Here’s a detailed breakdown of the role:

    Position Overview:

    The Sr. Specialist will primarily manage the triage and response to inquiries from healthcare providers and external stakeholders, overseeing medical information processes and promotional review compliance.

    Key Responsibilities:

    Medical Information:

    • Inquiry Response: Address unsolicited on-label and off-label inquiries from healthcare providers and stakeholders.
    • Professional Communication: Ensure responses are high-quality, scientifically accurate, and professionally communicated.
    • Standardization: Develop standardized answers for frequently asked questions in collaboration with Medical Advisors and MSLs.
    • Research & Clinical Support: Research and compile information from literature to provide clinical support in a balanced and accurate format.
    • Adverse Event Reporting: Report any adverse events or product quality complaints to the relevant departments.

    DPOC (Designated Point of Contact) Process Management:

    • Product Inquiry Management: Ensure proper classification and routing of product inquiries to meet regulatory and business requirements.
    • DPOC Database Maintenance: Maintain the DPOC database and ensure it is accurately updated.
    • Key Performance Metrics: Generate and report DPOC metrics monthly.
    • Gap Identification: Identify process gaps and provide solutions to improve the medical information process.
    • Training & Support: Train Medical Advisors and MSLs in managing DPOC and medical information requests.

    Medical Review:

    • Promotional Material Review: Oversee the review and approval process for promotional materials, ensuring compliance with regulations and internal policies.
    • Regulatory Knowledge: Stay informed about regulations and laws governing promotional materials.
    • Compliance Leadership: Provide guidance and training on compliance to country staff.

    Required Experience and Skills:

    • Experience: At least 3 years of pharmaceutical experience, preferably in medical information, contact centers, or medical review. Experience in women’s health products is preferred.
    • Scientific Integrity: High level of scientific and ethical integrity, with a strong sense of responsibility for response deadlines.
    • Communication Skills: Excellent written and verbal communication skills, along with strong collaboration abilities.
    • Regulatory Knowledge: Understanding of domestic regulations and industry codes.
    • System Knowledge: Familiarity with core systems, tools, and metrics related to medical literature.
    • Language: Business-level proficiency in English.

    Organon Overview:

    • Organon is a $6.5 billion global healthcare company focused on improving the lives of women and their families through a diverse portfolio of health solutions, particularly in women’s health, biosimilars, and other therapeutic areas.
    • The company is committed to diversity and inclusion and is an equal opportunity employer.

    Additional Information:

    • Employee Status: Project Temps (Fixed Term)
    • Relocation: No relocation assistance
    • VISA Sponsorship: Not available
    • Travel Requirements: Must meet applicable travel and credentialing requirements, including vaccinations.
    • Flexible Work Arrangements: Likely available depending on business needs.

    This position offers an experienced individual the chance to manage medical information processes and ensure the high standards of medical communications, with a focus on women’s health.

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