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    Medical Affairs Associate Manager

    Integrated Resources Inc
    2+ years
    $53.33 per hour
    Foster City
    10 Oct. 2, 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: Manager, Global Medical Affairs (Hepatitis B)

    Position Overview:
    This contractor role is part of the LIFE (Liver, Inflammation, Fibrosis, and Established Products) Medical Affairs organization, reporting to the Executive Director of Global Medical Affairs for Hepatitis C. This is a global position focused on developing and executing strategies for products within the LIFE franchise, with a particular emphasis on Hepatitis B. The ideal candidate will be a self-starter capable of leading both strategic and tactical initiatives. This role also offers opportunities to collaborate closely with the global liver diseases medical affairs group.

    Key Responsibilities:

    • Subject Matter Expertise: Demonstrate in-depth knowledge of LIFE products, as well as the client pipeline and competitive landscape.
    • Presentation Development: Create presentation materials for internal and external meetings, including Advisory Boards.
    • Training and Support: Act as an information resource and trainer for client colleagues, including Medical Scientists, on medical educational activities, grants, and investigator-sponsored studies.
    • Data Generation Activities:
      • Conduct critical reviews of global Investigator-Sponsored Research (ISRs), Phase 3b, and Phase 4 study proposals.
      • Manage the HBV Phase IV portfolio, coordinating with clinical operations and local affiliates.
      • Review abstracts and manuscripts arising from the Phase IV program.
      • Support the management and documentation of Phase IV study status.
    • Medical Affairs Expertise: Serve as a therapeutic area expert on Global Publications and the Scientific Message Platform committees, supporting Scientific Communications.
    • Scientific Meetings: Provide medical and scientific coverage at key scientific meetings.
    • Project Support: Assist project leads in executing and tracking initiatives (e.g., Global Medical Affairs Plan of Action, publications, reviews of medical and commercial assets).
    • Promotional Material Review: Oversee the medical and scientific review of promotional materials for the Governance Review Committee (GRC) and Medical Review Committee (MRC).
    • Additional Responsibilities: Engage in other activities as assigned to support LIFE Medical Affairs.

    Essential Skills:

    • Communication: Exceptional written, verbal, and interpersonal skills, with a focus on relationship-building and negotiation.
    • Organizational Abilities: Strong organizational skills for effective project planning, with the ability to anticipate and prioritize workload across multiple activities.
    • Teamwork: Excellent collaboration skills; organized, detail-oriented, and capable of meeting deadlines in a fast-paced environment.
    • Analytical Skills: Proven analytical and problem-solving abilities, with a talent for identifying complex issues and extracting key findings from study data and publications.
    • Public Health Experience: Experience in public health or Internal Medicine (general or subspecialty) is highly desirable, alongside clinical patient care.
    • Scientific Communication: Proficient in developing abstracts, manuscripts, posters, and presentations for scientific meetings.
    • Regulatory Knowledge: Comprehensive understanding of regulatory and legal requirements (Business Conduct) for clinical trials and Medical Affairs activities, including FDA regulations, ICH guidelines, and GCPs.
    • Autonomy: Ability to work independently and autonomously.
    • Flexibility: Willingness to work across international time zones and travel for domestic and international conferences, including occasional weekend travel.

    Knowledge, Experience & Skills:

    • Education: Minimum of a Bachelor’s degree; M.D., D.O., Ph.D. (biological or pharmaceutical sciences), or PharmD preferred. Experience in hepatology, infectious diseases, virology, or clinical virology is a plus.
    • Professional Experience: Preferred background in Medical Affairs and/or Clinical Research, particularly with Phase IIIb and IV studies, clinical trials management, and medical monitoring.

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