Job summary
| Job category | Professional (Consulting / Finance / Real Estate / Professional Services)／Professional Services (Health Care / Welfare / Education / Instruction) |
|---|---|
| Industry | Health Care／ Other Health Care |
| Employment type | Uncategorized |
| Position level | Other |
| Number of openings | 1 |
| Desired entry time | - |
| Required language skill |
Japanese （Fluent） English （Business） |
| Foreign language competence | - |
| Working hours | Others |
| Welfares / Leave systems | |
| Assistance in visa application | - |
| Number of foreign employees | - |
Work details
Company Overview
大手外資系製薬メーカー／福利厚生充実／強いパイプラインと女性管理職が多いのが特徴
Job Description
下記の業務を通じて、新薬開発における治験の実施並びに承認取得に貢献する
治験薬概要書の作成
総括報告書の作成
承認申請資料（CTD）臨床パートの作成
開発製品の添付文書案（臨床部分）の作成
対面助言（申請前相談）資料の作成
承認申請後の臨床パートに関する照会事項回答の作成
臨床試験情報登録サイトへの臨床試験結果の公開（米国本社と共同で行う）
Contribute to clinical studies and regulatory approvals for new drugs through the works listed below
Investigator’s Brochure
Clinical Study Report
Clinical part of Common Technical Document (CTD)
Clinical portion of draft Package Insert for drugs before regulatory approval
Documents for consultation with PMDA (Pre-filing consultation)Response to clinical-related inquiry by PMDA during regulatory review after submission
Disclosure of clinical study result on the clinical trial information registries (collaborating with the U.S. headquarters)
Requirements
必須条件：
CTD臨床パート（モジュール2.5、2.7）及び照会事項回答の作成経験
オンコロジー領域の臨床開発経験
英語力（TOEIC 730点相当以上、海外本社との会議やメールで問題なく交渉できる）
Prerequisite:
Experience of authoring CTD clinical parts (Modules 2.5 and 2.7) and response to inquiry by PMDA
Experience of oncology clinical development
English skills (corresponding to TOEIC score of over 730, capable of smooth negotiation with overseas staff at meetings and by emails)
About interview
Liaison
Medical Writing(Oncology)
RGF HR Agent
450 〜 1100 ten thousand JPY
