Sr. Medical Writer at Top Global Biopharma (Tokyo or Osaka)

Tokyo 23 Wards Permanent ¥10,000,000 - ¥15,000,000 per year Foreign Multinational Work from Home or Hybrid
  • One of the top global biopharma supporting various unmet medical needs
  • Lead in authoring clinical regulatory documents and submissions successfully

About Our Client

  • One of the largest leading biopharmaceutical company in the industry
  • Rich development pipeline specialising in oncology, immunology, vaccines, CNS, etc. for unmet medical needs
  • Highly patient-centric focused for new drug development to deliver cutting edge products/therapies
  • Global working environment with continuous interactions with global stakeholders
  • Hybrid working style

Job Description

  • Take lead in authoring essential clinical regulatory documents for submission effectively obtain/maintain product development approval
  • Take charge in documents such as CTD, IB, CSR, CSP, MICF, and other critical documents to align business objectives
  • Ensuring overall quality of documents are up to company standards to help support for PMDA consultations
  • Review other essential documents such as translation to product labels and other overall communication

The Successful Applicant

  • University degree in a scientific or related area
  • Medical writing experience in the pharmaceutical industry
  • Ability to translate documents successfully
  • Deep knowledge of overall drug development process and up to date regulations/guidelines
  • Exposure to regulatory submissions to PMDA/MHLW as well as responding to inquiries
  • High fluency in English or Japanese (Non-native level speakers will not be selected)

What's on Offer

  • Competitive salaries and benefits
  • Global working environment
  • Great work life balance
  • Amazing career progression in medical writing
  • Work with industry leaders who are solving various unmet medical needs
Zach Itozu
Quote job ref
Phone number
+813 6832 8683

Job summary

Life Sciences
What is your area of specialisation?
Healthcare / Pharmaceutical
Tokyo 23 Wards
Job Type
Consultant name
Zach Itozu
Consultant phone
+813 6832 8683
Job Reference
Company Type
Foreign Multinational
Work from Home
Work from Home or Hybrid

Diversity & Inclusion at Michael Page

We don't just accept difference - we celebrate it. We encourage applicants from all backgrounds to apply for this role and are committed to building inclusive, diverse workplaces where everyone can thrive. If you require any support or reasonable adjustments during the recruitment process, please let us know.