SD, Oncology Medical Affairs Lead, Japan

4週間前

Tokyo Pfizer Full time

Position Purpose

Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives. In this position, you will:

  • provide leadership to dedicated medical affairs team
  • be responsible for development of the Medical Plan and Strategy for oncology
  • be a member of the Country Medical and the Oncology Commercial Leadership Team
  • ensure compliance of medical team with country Code of Practice and relevant procedures, regulations and guidelines
  • work closely with internal and key external stakeholders supporting Pfizer strategy and bringing medical insights as well as support for media, government and patient group activities, including policy development, corporate initiatives and issues management
  • take accountability for reviewing and certificating promotional and non-Promotional materials
  • give input into HEOR submissions, HTA dossiers, clinical guideline consultations and regional formularies
  • closely collaborate with Development Japan by providing input on development and regulatory strategies
  • support for issues related to supply and distribution, product quality, benefit-risk, market actions and product withdrawals

    • Responsibility

  • Leadership of medical team, including setting business objectives, performance management and team development
  • Responsibility for development of the Medical Plan/Strategy for relevant therapeutic areas
  • Recruitment, development and retention of talented colleague
    • Coaching and guidance of colleagues to support them achieving their maximal potential
  • Membership of Medical and Commercial Leadership Teams
  • Resource allocation to ensure appropriate resources to fulfil medical objectives and business needs
  • Ensure compliance of medical team with country Code of Practice and relevant SOPs, regulations and guidelines
  • Collaboration with internal stakeholders to ensure timely receipt of information on brand strategy, clinical plan, new clinical data, new regulatory and safety information and accurate, balanced and up to date materials to use in medical to medical communications
  • Work with key external stakeholders during the life-cycle of Pfizer medicines, supporting Pfizer strategy and bringing external insights to the organisation to shape strategy and providing focused, relevant information in response to their needs
  • Review and certification of promotional and non-promotional materials and activities and approval of customer engagement programs
  • Ensure that product materials and related activities reflect the most up to date regulatory labelling and risk management plans and regulatory commitments
    • Input into regulatory submissions, clinical overviews, license variations and CDS updates as required
    • Input into HEOR submissions, HTA dossiers, clinical guideline consultations and regional formularies as required
  • Input into assessment and due diligence of business development initiatives
    • Support for issues related to supply and distribution, product quality, benefit-risk, market actions and product withdrawals related to portfolio
  • Support for in country clinical research programs, including protocol and site feasibilities related to portfolio
  • Protocol approval and oversight of in country non-interventional studies related to portfolio
  • Support for investigator sponsored research (ISR) studies to ensure that appropriate records are kept and progress is monitored
  • Support for media, government and patient group activities, including policy development, corporate initiatives and issues management
  • Participate in local, regional and global cross-functional project teams to ensure that ongoing improvements in processes and performance are delivered
  • Accountable for medical team IIR and headcount/expenses budgets
  • Represent the country and countries interests to European and Global teams

    • Desired Skill Set

  • MD / Ph.D with knowledge in oncology
  • Significant pharmaceutical industry experience (oncology preferable) and excellent understanding of the local healthcare environment
  • Qualifications to act as in country signature, or have qualifications and potential to become a medical signatory is mandatory
  • Excellent communication and presentation skills both in English and Japanese
  • Good knowledge of pharmaco-vigilance and regulatory legislation and how it impacts the product portfolio
  • Good knowledge of drug development
  • Strong people management and leadership skills and excellent business acumen
  • Ability to prioritize resources in line with brand and customer strategy
  • Team player
  • High degree of cross-functional leadership and collaboration
  • Communication and influencing skills
  • Role modelling, upholding values, adhering to standards, visibility Leadership skills
  • Fluent language skills in Japanese and English

    • Organizational Relationships

    You will collaborate closely with Medical Leads in other therapeutic areas and ONC commercial leadership team as well as the relevant platform functions such as Regulatory Affairs, Drug Safety, MQO, Medical Operation, Medical Information, Medical Grant Management, Compliance, Legal and Product quality to ensure adequate external representation.

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

    Medical#LI-PFE

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