Medical Writer (All Levels)

■ Creation of clinical study protocols ■ Creation of clinical study reports ■ Preparation of pharmaceutical approval application documents (CTD: Common Technical Document) (non-clinical or clinical part) ■ Preparation of investigational drug summaries ■ Review of the above-created documents ■ Regulatory correspondence (document creation, review, or consulting for clinical parts, etc.) ■ General consulting for document creation that meets regulatory requirements ■ Appropriate guidance for less experienced members and contribution to members' growth * For Principal Medical Writer/Senior Medical Writer positions, leading the Medical Writing part of the project team is also expected.


SalaryJPY 5000K - JPY 12000K
Work TypeFULL_TIME
Applicant needs to be in Japan
Applicant needs to speak Japanese
Is accommodation included?
Is food included?
Minimum Commitment

Language Requirements

Business Conversation Level English
Fluent (JLPT Level 1 or N1) Japanese

Qualifications

Experience in preparing major regulatory submission documents as a medical writer
Sufficient knowledge of the clinical development process from protocol design to approval application, including technical issues
Knowledge of regulatory requirements, ICH guidelines, and document creation (including CTD) related to pharmaceutical processes

Requirements

More than 3 years of experience in medical writing at a pharmaceutical company or CRO (experience in academia is also negotiable)

The above information is a public job ad. This job ad is neither an offer nor a contract.

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