募集要項
- 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
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正社員 ※試用期間：3カ月
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
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Work location: Head office: Shinagawa－ku, Tokyo
勤務地：本社：東京都品川区
- 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 available
＊Staff employees receive overtime pay
勤務時間：8時45分～17時20分 （休憩45分含む）の7時間50分 を基本
※フレックスタイム制（コアタイムなし）
※テレワーク可能
- 年収・給与
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Expected annual salary （guideline）: 8 million to 12 million yen
年収・給与：
想定年俸（目安）：800万円～1200万円程度
※年齢、経験、現年収、potential等を考慮して決定。
※想定年収は、月給＋業績賞与（年1回：4月支払い）の合計額。
※残業手当、その他手当は別途支払い（スタッフの場合）
(上記および待遇・福利厚生の一部は今後変更される場合があります。）
- 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
待遇・福利厚生：
各種社会保険（健康保険・厚生年金・雇用保険・労災保険）完備、出産一時金、退職金制度、借上社宅制度（弊社規定に依る）、福利厚生倶楽部（日本リロケーション）法人会員、カジュアルフライデー制度（内勤）、財形貯蓄、福利厚生倶楽部法人会員、共済会、持家ローン利子補給制度等
・育児支援、医療費補助（配偶者、扶養家族も対象）や賃貸家賃補助（引越し費用、下見交通費を含む）なども含め、福利厚生は大変充実しています。
・多くの職種においてコアタイムのない完全フレックスタイム制度や、オフィス以外の場所からでも勤務できるテレワークを推進し、柔軟かつ効率的な働き方を志向しています。
※社内全面禁煙
- 休日休暇
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Holidays: 2 days off per week, 120＋ days off per year
完全週休2日制、年末年始、祝日、創立記念日（7/1）、セレクト休日、祝日が土曜に重なった場合は翌労働日が休日、フレックス休暇、リフレッシュ休暇、慶弔休暇
＊年間休日数120日以上
＊有給休暇：初年度は4～13日（入社月により変動）
- 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）.
書類選考、面接(2回）、適性検査
※一次面接はWEB、電話での対応も可能です。
※二次（最終）面接は神戸または東京本社で実施、交通費等は実費を支給します（平常時）。
付記：
【職業安定法施行規則改正（令和６年４月１日施行）に伴う明示】
１ 従事すべき業務の変更の範囲：会社内での全ての業務を命じることがある。
２ 就業の場所の変更の範囲：当社の全事業場および出向先・派遣先としての他の会社・法人・団体。
- キャリアパス・評価制度
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Career Path：
・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.
