Medical Writer at Top Global Biopharma (Kanto or Kansai)

Take lead in medical writing activities in authoring clinical/regulatory documents as well as submission requirements to obtain product approval. Align with global business strategies for local requirements
Client Details
* One of the top global biopharmaceutical companies in the industry
* Specializing in oncology, infectious diseases, cardiovascular, rare disease, and other TAs for various unmet medical needs
* Patient-centric organization with cutting edge products and therapies
* Heavy investment in new drug development as well new research
* Global cultured organization
Description
* Take lead in authoring clinical and regulatory documents as well submission requirements
* Focusing on clinical parts of documentation such as CTD, CSR, IB, etc. to align company objectives in an efficient manner
* Coordinate with other documentation support with external vendors such as CROs
* Authoring clinical parts for briefing documents for PMDA consultation and review other requirements
Profile
* University degree in scientific or related field
* Fluency in English and Japanese (non-native level speakers will not be selected)
* Experience in clinical development with comprehensive knowledge of overall drug development process
* Track record in writing clinical documents, delivery in regulatory submissions
* Deep knowledge of regulations and guidelines
* Experienced in supervising outsourced resources
Job Offer
* Competitive salaries and benefits
* Great work life balance
* International working environment
* Amazing career progression in medical writing
* Work with industry leaders who are solving various unmet medical needs
Page Group Japan is acting as an Employment Agency in relation to this vacancy.