募集要項
- 募集背景
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- 仕事内容
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Oncology Medicine/Clinical Development Early Evidence CPL position【Basic purpose of the job】
In collaboration with the global early asset teams, the early evidence leads, other stakeholders in Medicine Division, our Reseach Institute, and the pipeline marketing teams, we will provide appropriate and robust insights into the oncology areas based on the Japan-specific medical environment, and achieve timely and accelerated approval of Our assets for target indications.
【Accountabilities】
・Responsible for making Japanese early clinical development plan authorized by Our global early Asset Teams as well aligned with global development strategy in Oncology therapeutic area.
・Ensure Japanese submissions and registrations in Oncology therapeutic area are appropriately handled and obtained.
・Ensure all the projects in Oncology therapeutic area are correctly managed in both in timeline and in quality.
・Support Our management team in making development and/or data building decision based on whole picture in Oncology therapeutic area.
・Ensure we provides safety related important information with appropriate assessment to stakeholders in timely manner during its product life in pre-launch phase.
・Support we obtains preferable pricing in Japan.
・Knowledge transfer to MA/MSL groups and other relevant business functions.
・Establish strong network with Japanese external experts supporting our product.
【Regulatory and / or Organisational Requirements】
-Ensure all the projects are correctly managed in timeline and quality
-Contribute to Strategy and Activity Review Committee meetings
-Ensure benefit/risk evaluations of products, ethics and compliance
-Ensure all the projects are correctly managed in timeline and quality
-Contribute to Strategy and Activity Review Committee meetings
-Ensure benefit/risk evaluations of products, ethics and compliance
-Ensure preparation of local Integrated Asset Plan (IAP) & Integrated Customer Plan (ICP) to include Japan specific needs, together with Asset Team colleagues & aligned with global IAP
- 応募資格
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- 必須
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【Job Expertise】
Full understandings of regulatory and compliance requirement in clinical development
【Minimum Education/Degree Requirements】
Bachelor of Science
【Required Capabilities (Skills, Experience, Competencies)】
The following are mandatory:
-Experience in "Oncology" clinical or research setting with or without own publications, 3+ years industry experience as CPL.
-Experience in PMDA consultation, the query response, and obtaining regulatory approval for the development compounds in charge.
-Ability to make your own proposals for modifying project plans to meet the actual situation in Japan or to enable accelerated approval, based on a global development strategy.
-Project management skills as a lead.
-English communication skills beyond daily conversation.
-Complete understandings of the current standard of care for specific cancer types .
- 募集年齢(年齢制限理由)
- under 45 （特定年齢層の特定職種の労働者が相当程度少ないため）
- 雇用形態
- Full-time employee ; Trial period: 3 months
- ポジション・役割
- Pharmaceutical Development HQ CDMA Oncology/Immunology Oncology Medicine Dept.1 / Non-Line Manager
- 勤務地
- Head office: Shinagawa-ku, Tokyo
- 勤務時間
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Working hours: 8:45－17:20 （including 45－minute break） for 7 hours and 50 minutes, with flexible working hours depending on work conditions
＊Flexible working hours （no core time）
＊Telework mainly
＊Staff employees receive overtime pay
- 年収・給与
- Expected annual salary （guideline）: 8 million to 12 million yen
- 待遇・福利厚生
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Benefits and Employee Benefits:
All types of social insurance （health insurance, pension insurance, employment insurance, worker's accident insurance）
Childcare support, medical expenses subsidies （including spouses and dependents）, and rental subsidies., etc
- 休日休暇
- Holidays: 2 days off per week, 120＋ days off per year
- 選考プロセス
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Document screening, interviews (2 times), aptitude test
-The first interview can be conducted online or over the phone.
-The second (final) interview will be conducted at the Kobe or Tokyo headquarters, and travel expenses will be reimbursed (under normal circumstances).
Note:
[Clarification following the amendment to the Enforcement Regulations of the Employment Security Act (effective April 1, 2024)]
1. Scope of changes in work to be performed: You may be ordered to perform all work within the company.
2. Scope of changes in place of employment: All of our company's business locations and other companies, corporations, and organizations as secondments or dispatches.
- キャリアパス・評価制度
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・As a non-listed company, management is stable and employee benefits are excellent.
・We place emphasis on human resource education and potential, and have a comprehensive training system for career paths, so it is an ideal environment to hone your career path with colleagues of a wide age range, from new graduates to seniors.
・There are many opportunities to interact in English, so it is a great environment for improving your skills. There is also an English learning assistance system in place.
