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Medical Writing; Associate Manager
- Medical Writing
- CTD creation
About Our Client
This company is a pharmaceutical manufacturer that specializes in rare diseases that are frequently overlooked by larger companies. The company has been in Japan for over ten years
* Translation/QC/editing work is performed independently following detailed instructions with well-defined procedures.
* Performs translation/QC/editing of documents such as BDs for PMDA consultation meetings, CTDs, and other Clinical or Regulatory documents in line with Gilead internal document standards.
* Author parts of regulatory documents, as needed.
The Successful Applicant
Past experience of creating regulatory affairs related documents for pharmaceutical products (CTD, CSR, etc.)
Business English (TOEIC 700 points or more, or an equivalent capacity)
Good knowledge of CTD creation, working with pharmacology and new drug approval application experience
People management experience
What's on Offer
8M - 12M salary depending on experience
Around 8% incentive bonus (Target)
Financial and other bonuses and perks