Greater Tokyo Area Randstad Japan

*We are only able to accept applicants with valid permission to work in Japan.

Thank you for your kind understanding.



■Company Overview

Global Pharmaceutical Company

■Position

Principal Medical Writer/Associate Director

■Job Description

・Independently author complex clinical regulatory documents like CSRs, protocols, and CTDs.

・Lead planning and production of clinical dossier documents for Japan and China regulatory submissions.

・Coordinate the full lifecycle of drafting, reviewing, and approving marketing application documents.

・Interpret complex statistical data to effectively organize content in clinical reports and summaries.

・Serve as the primary Medical Writing lead for assets, ensuring timely delivery of quality documents.

・Drive collaboration between Japan and China teams to ensure delivery aligns with global standards.

・Oversee 3rd party vendors and lead process improvement initiatives like simultaneous submissions.

・Provide strategic input on analysis plans and lead implementation of best practices and standards.

■Requirements

・Over 7 years of clinical regulatory writing experience in the pharmaceutical industry.

・Experience authoring documents such as clinical overviews, clinical study reports, clinical study protocols, and responses to regulatory authority inquiries.

■Industry

Medical Devices/Pharmaceuticals

■Salary

7M ~ 15M JPY

■JOB ID: VAC-283147

*Apply via Randstad's website via the button above. Finish your application by filling out the required information.

Please note the registration page will be in Japanese.



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