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 |
English (Business) |
Foreign language competence | - |
Working hours | Others |
Welfares / Leave systems | |
Assistance in visa application | - |
Number of foreign employees | - |
Work details
Company Overview
大手外資製薬メーカー/オンコロジー領域へ注力/福利厚生充実
Job Description
糖尿病、循環器、ワクチン、感染症、中枢神経、呼吸器・免疫・骨領域のいずれかの疾患領域について、クリニカルリーダーと協働して以下の業務を担当する:
・開発戦略策定
(早期及び後期開発計画書への日本での臨床開発に関するインプット)
・開発戦略に基づいた機構相談の立案、資料の作成、及び照会事項に対する回答作成
・治験実施計画書の立案及び作成
-ローカル試験(試験骨子から作成)
-グローバル試験(日本で実施するための計画書の適性化)
-本社や海外ベンダーへの説明、交渉を含む
・同意説明文書(会社案)の作成
・治験実施計画書に関連する資料(症例報告書、関連手順書、等)の作成サポート及びレビュー
・治験データメディカルレビュー
・治験総括報告書及び承認申請資料(CTD)臨床パートの作成(メディカルライターと協働)及びレビュー
・学会発表、論文作成及びそれらのサポート
・開発関連部門との連携により臨床試験実施の中心的役割を担う
The following responsibilities are to be fulfilled by the candidate in one of the therapeutic areas including diabetes, cardiovascular, vaccines, infectious diseases, neuroscience, respiratory immunology and bone :
・Formulate development strategies
(Provide input on clinical development in Japan for early and late phase development plans)
・Make plans for PMDA consultation meetings based on the development strategy, prepare materials, and respond to inquiries from health authorities
・Plan and develop clinical trial protocols
-Local Studies(Start with drafting of study synopsis)
-Global Studies(Optimize protocols for studies to be conducted in Japan)
-Including explanation to, and negotiations with the headquarters and overseas venders
・Develop Informed Consent (Company Draft)
・Provide support for development and review of study protocol related materials (e.g. CSR, SOP,etc.)
・Perform medical review of clinical trial data
・Develop (in collaboration with medical writers) and review Clinical Study Reports (CSRs) and the clinical section of the Common Technical Document (CTD)
・Make presentations at scientific meetings and author manuscripts, or provide necessary support
・Assume a central role in the conduct of clinical trials in cooperation with the relevant departments
Requirements
必要とする資質:
・医薬品臨床開発業務の経験(5-15年)
・治験実施計画書の作成経験
・社内(国内・外)関連部門及び外部専門医との密接な協働作業のためのコミュニケーションスキル
・TOEICスコア730以上に相当する英語力
・薬学あるいは生命科学に関する専門知識
望ましい資質:
・CTD作成、治験総括報告書作成、承認取得、CRA業務
・以下の疾患領域の開発経験:糖尿病、循環器、ワクチン、感染症、中枢神経、呼吸器・免疫・骨領域
・早期臨床試験の立案及び実施(Study management)の経験があれば尚可
Required Skills and Abilities:
・Work experience in drug development (5-15 years)
・Experience in development of clinical trial protocols
・Good communication skills essential for a close collaboration with internal (Japan and ex-Japan) relevant departments and external experts
・English level equivalent to TOEIC score above 730
・Specialized knowledge in pharmacy and life science
Preferred Skills and Abilities:
・CTD development, CSR development, obtainment of JNDA approval, CRA/Monitor experience
・Work experience in the development of the following therapeutic areas: diabetes cardiovascular, vaccines, infectious diseases, neuroscience, respiratory immunology and bone
・Experience in the planning and execution of early phase clinical trials(Study management)is preferred
About interview
Liaison
Clinical Scientist(Without Oncology)
RGF HR Agent
800 〜 1200 ten thousand JPY