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    Senior, Medical Advisor

    Pfizer
    5-6 years
    Not Disclosed
    Mumbai
    10 Aug. 7, 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, 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

    Primary Responsibilities

    The Medical Affairs Manager for the Oncology portfolio at Pfizer India is responsible for developing and executing comprehensive medical strategies in alignment with commercial objectives. The role involves close collaboration with internal stakeholders such as marketing, sales, regulatory, medical information, drug safety, and clinical development teams to support the allocated Oncology portfolio. The individual will lead and mentor the Oncology Medical team, engage with external stakeholders like Key Opinion Leaders and regulatory bodies, and ensure compliance with all internal and external regulations. The position requires strategic oversight of medical plans, research proposals, promotional strategies, and budget management, while adhering to Pfizer policies and local regulations.

    Position Responsibilities

    1. Strategic/Policy:

      • Develop and implement medical affairs strategies in collaboration with the country commercial team for the Oncology portfolio.
      • Align local medical plans with global strategies and best practices, ensuring adherence to internal and external regulations.
      • Provide tactical inputs to support ethical promotion and strategic planning for assigned products.

    2. Operational:

      • Oversee commercialization and promotion of allocated products, including creation of marketing plans and execution of medical-marketing programs.
      • Review and approve promotional, training, and Continuing Medical Education (CME) materials to ensure compliance with regulations.
      • Conduct and facilitate interactions with Health Care Professionals (HCPs), including advisory boards, scientific symposia, and institutional presentations.

    3. Clinical Research:

      • Develop, review, and approve clinical trial protocols and related documents, including informed consent forms and patient information sheets.
      • Collaborate with Study Management to train project teams on clinical research methodologies and study design.
      • Review and interpret clinical data, prepare final reports, and develop publication plans for locally sponsored studies.

    4. New Product Planning/Development:

      • Assist in preparing business cases and pre-commercialization programs for new global products.
      • Support New Product Planning, Marketing, and Business Development with medical evaluations and recommendations on commercial opportunities.
      • Coordinate internal and regional approvals for local formulations and line extensions.

    5. Regulatory:

      • Provide medical expertise for product registration and defense of marketed products.
      • Write, revise, and review labeling documents and support adverse event reporting as required.

    6. Medical Information:

      • Deliver accurate and balanced medical information to both internal staff and external HCPs, adhering to relevant SOPs and policies.

    7. Sales Force Training:

      • Provide medical training to sales staff on assigned products and therapeutic areas, including pre-launch and launch training.

    Required Skill Set

    • Qualification & Experience:

      • MD with 5-6 years of progressive experience in the pharmaceutical or allied industry, preferably in Oncology.
      • Proven track record in leading medical affairs strategies across therapeutic areas and building strong stakeholder relationships.

    • Special Skills & Knowledge:

      • Deep knowledge of therapeutic segments, regulatory aspects, and Pfizer’s policies and procedures.
      • Strong strategic mindset and experience in managing medical strategy plans, local health policies, and regulatory requirements.
      • Excellent communication skills and the ability to lead innovative medical affairs projects.

    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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