Associate Director Study Alliance Management, Development Operations Division

計画から規制検査に至るまでの完全なアウトソーシング研究に関するアライアンスの最適化に貢献

仕事内容

・Associate Director Study Alliance Management (ADSAM) is accountable/responsible for oversight of related full outsourcing studies to achieve milestones as scheduled with maintenance of quality and mediator among Japan CRO study team, Global CRO representative, Japan Associate Director Clinical Development (J-ADCD) and Global clinical team.

・The ADSAM will contribute to optimize an alliance on full outsourcing studies from the planning to the regulatory inspections (e.g., create/improve oversight platform, the agreement and Japan specific requirements through influencing global alliance team members, and optimize upcoming study operation planning/execution by J-ADCD).

・The ADSAM will take capability and skill development for Japan Study Manager (J-SM) and contribute to improve related activities in the Japan Development Operations (J-DO).

応募条件

【必須事項】

・Bachelor’s Degree
・At least 5 years’ experience in pharmaceutical industries or multinational healthcare organization.
・Extensive knowledge of clinical operations, project management tools and processes
・Proven experience of clinical development / drug development process in various phases of development and therapy areas including health authority GCP inspection.
・Proven ability to learn by working in multiple phases, TAs and/or different development situations.
・Experience from leading clinical projects and deliverables or similar expertise from other areas of drug development (such as pharmaceutical development).
・Extensive knowledge of clinical operations, project management tools and processes
・Understanding of the skills and knowledge required for the successful delivery of a clinical study, e.g. ICH-GCP/J-GCP, local regulations, study management
・Good experience of clinical development / drug development process in various phases of development and therapy areas
・Excellent communication, relationship building, and negotiation skills
・Proactively identifies risks and issues and possible solutions
・Basic knowledge and experience of quality management

語学：
日本語 Japanese：ネイティブ
英語 English： Business English (Achieve common understanding at the context level with customers)

【歓迎経験】

・Working with external bodies, such as co-development companies and key opinion leaders, as a leading person.
・Leadership of significant cross-functional change programmes/initiatives

【免許・資格】

【勤務開始日】

応相談

学歴

大学卒以上

雇用形態

正社員

試用期間

6ヶ月

勤務地

在宅可、大阪、東京

転勤の有無

転勤なし

受動喫煙防止措置

敷地内禁煙（喫煙場所なし）

勤務時間

フレックス制度あり　コアタイムなし

休憩時間

60分

時間外労働

有

勤務開始日

応相談

休日休暇

完全週休2日制(土・日)、祝日、年末年始(6日)、年間休日122日(2009年実績)、年次有給休暇(初年度は入社日に応じて変わりますが、次年度からは1月1日で20日間が毎年付与されます。)、慶弔・赴任・リフレッシュ、頭痛休暇ほか

年収・給与

年収　　800万円～1500万円　経験により応相談

諸手当

住宅手当、通勤手当、単身赴任手当、休日手当ほか

昇給

年１回

賞与

年間標準6ヶ月

採用人数

1名　

待遇・福利厚生

【待遇】

社宅制度、厚生年金基金、退職年金、財形貯蓄、融資制度、持株会制度、各種社会保険、リスクベネフィット（特別弔慰金、入院見舞金及び治療給付金、災害補償）、ほか慶弔見舞金マルティプル・エンプロイメントシステム、ストックボーナス

【福利厚生】

選考プロセス

１）書類選考
２）一次面接
３）最終面接