Senior Manager of Real World Evidence - 製薬会社

※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.

[Company Description]
外資系製薬会社

[Responsibilities]
■PURPOSE
The senior manager of real world evidence (RWE) will develop and execute RWE programs for company supporting Japan affiliate. The person will work closely with MA team and market access members to address identified data gap and generate evidence contributing to HCPs and patients throughout product lifecycle. He/she support Japan affiliate thorough leading non-interventional studies to support local medical needs and engage with multiple stakeholders within affiliated company (both at the head office and in the affiliates). This role must be able to establish strong working relationships internally with country heads, corporate affairs heads, and partner functions in the global head office working for RWE, e.g., Global Information and Predictive science and Global Medical Affairs, etc.

■STAKEHOLDERS
Internal

  • Medical Affairs
  • Clinical Development/ Operations
  • Sales and Marketing
  • Regulatory Affairs
  • Drug Safety

External

  • KOLs, researchers and Other HCPs
  • Regulatory agency
  • Patients advocacy group
  • Vender / Agents

■TASKS & RESPONSIBILITIES
Under the direction of the Head of Medical Affairs Japan, he/she is responsible for developing and driving the RWE agenda thorough product lifecycle. He/she is responsible for translating unmet medical needs into effective RWE that aligns with global and Japan medical strategy. He/she is accountable for a smooth delivery in the broad range of RWE strategy
Responsibilities include, but are not limited to:

  • Translates clinical question into research question and lead non-interventional study planning/execution including protocol development, data collection, data analysis, publication and oversight of outsourcing vendors.
  • Collect, collate and analyses relevant information to improve RWE and medical strategies, which includes availability of emerging databases (such as EHR, disease registry etc), analytics and update of regulations.
  • Responsible for standardizing the process for generating RWE including overseeing external vendors (e.g. statistical analysis etc.)
  • Build strong relationship with external experts of epidemiology and outcome research.
  • Coordinate and undertake systematic literature reviews to inform disease epidemiology and provide RWE strategy contributing to clinical development and filling unmet medical needs.

[Requirements]

  • Master of epidemiology or public health required, PhD preferred
  • Solid experience in epidemiological research with evident publications required
  • Understanding of the healthcare systems in Japan is required
  • Strong project management skills.
  • Demonstrated experience in managing multiple cross functional projects and related budget required
  • Build excellent teamwork and ability to manage projects with uncertainty
  • Demonstrated understanding and working under global environment
  • Excellent communication and presentation skills
  • Excellent communication in English; working knowledge in Japanese.
  • 3+ years of relevant pharma industry experience in particular specialty products is preferred
  • Experience in hematology/oncology and/or Inflammation/Immunology area preferred

[Employment Type]
Full time

[Salary]
13M-16M yen
※Experiences and skills will be considered

[Location]
Tokyo


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