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    Senior, Medical Advisor

    Pfizer
    5-6 years
    Not Disclosed
    Mumbai
    10 Aug. 7, 2024
    Job Description
    Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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

    Position Title: Senior Medical Affairs Manager - Oncology

    Position Purpose: The Senior Medical Affairs Manager will drive the development, execution, and integration of medical strategies for Pfizer India's Oncology portfolio. This role involves collaborating with various internal stakeholders, including commercial, regulatory, medical information, drug safety, clinical development, legal, compliance, and business unit medical affairs teams. The focus will be on aligning medical plans with commercial goals, ensuring compliance with regulations, and fostering relationships with key external stakeholders.

    Primary Responsibilities:

    • Strategic Planning: Collaborate with the country commercial team to develop and execute medical affairs strategic plans for Oncology products. Align these plans with global medical strategies and local business objectives.
    • Regulatory and Clinical Coordination: Work with regulatory and clinical development teams to ensure timely and compliant new product launches. Ensure adherence to internal and external regulations.
    • Team Leadership: Partner with the Medical Lead Oncology to mentor and develop the Oncology Medical team members.
    • Global Integration: Engage with regional and global medical affairs teams to incorporate global best practices into local medical plans.
    • External Engagement: Build relationships with key opinion leaders, patient and physician associations, and regulatory bodies to gather insights, advocate for the portfolio, and align with Pfizer policies and local regulations.
    • Scientific Dissemination: Represent Pfizer at key scientific congresses and ensure the dissemination and collection of relevant scientific information.
    • Project Review: Review and approve research proposals, grant proposals, publication plans, and other medical projects to ensure alignment with commercial strategies.
    • Promotional Strategy: Oversee the conceptualization and medical review of promotional strategies to ensure they are scientifically sound, compliant with regulations, and align with Pfizer policies.
    • Budget Management: Plan and manage the medical affairs budget for the assigned portfolio, ensuring effective resource allocation for key brands and projects.
    • Compliance: Ensure all activities related to the Oncology portfolio comply with local policies, procedures, and regulations.

    Strategic and Operational Responsibilities:

    • Strategic Input: Provide tactical and strategic input to product management for the ethical promotion of assigned products. Create medical strategies that align with commercial goals and customer insights.
    • Promotion and Commercialization: Support the creation of marketing plans, medical development plans, and medical-marketing programs. Review and approve promotional, training, and CME materials.
    • Clinical Research: Develop and review clinical research protocols and supporting documents. Assist with Investigational New Drug Applications (NDAs) and review study data.
    • New Product Planning: Support new product planning efforts, including market research, stakeholder mapping, and pre-commercialization programs.
    • Regulatory Support: Provide medical expertise for product registration and defense. Write and review labeling documents and support adverse event reporting.
    • Medical Information: Deliver accurate and balanced medical information to internal and external stakeholders.
    • Sales Force Training: Provide medical training to sales staff, including pre-launch, launch, and ongoing training.

    Required Skill Set:

    • Qualifications & Experience:

      • MD required with 5-6 years of progressive experience in medical affairs and clinical development, preferably in Oncology.
      • Proven ability to lead and execute medical affairs strategies across multiple therapeutic areas.
      • Experience building strong relationships with key stakeholders and leading innovative medical projects.
      • Strong communication and relationship-building skills.

    • Special Skills & Knowledge:

      • Knowledge of therapeutic segments, medical information, and regulatory aspects of the pharmaceutical industry.
      • Familiarity with Pfizer policies and procedures, including promotional practices and adverse event reporting.
      • Strong strategic mindset and understanding of local health policies and regulations.

    Location: Pfizer India

    Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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