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| 部署・役職名 | メディカルアフェアーズグループマネージャーorメディカルアドバイザー/グループマネージャーorノンラインマネージャー /医薬開発本部クリニカルディベロップメント・メディカルアフェアーズ心・腎・代謝領域 |
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| 職種 | |
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| 仕事内容 |
【Basic purpose of the job】 To contribute to execute CDMA （Clinical Development ＆ Medical Affairs） activities in Japan according to TA （Therapeutic Area） strategy between start of preclinical development and late stages of commercialization. 【Accountabilities】 ・Strengthen the profile of our products by providing medical/scientific robust guidance in the responsible therapeutic area through the total process of the clinical development phases, in collaboration with Global and other departments. ・Ensure and support Japanese submission and registrations in the respective products collaborating with regulatory/ clinical development team. （Support the clinical part until approval, such as preparation of responses to PMDA queries.） ・Responsible for making Japanese clinical development plan recognized by global Medicine as well aligned with global development strategy in the respective therapeutic area. ・Support our company make development/data building decision based on total picture （all projects/trials in the respects of resource/budget） in the therapeutic area. ・Contribution to CDPs （Clinical Data Packages） after proof of concept and late stages of commercialization. ・Prepare Integrated Customer Plan to address Japan specific needs, together with Marketing and Market Access ＆ aligned with global IAP （Integrated Asset Plan）. ・Build new scientific evidence by collaboration with external experts through clinical/pre－clinical researches, investigator initiated studies and RWE （Real World Evidence） studies. ・Contribution to benefit/risk evaluations of products. ・Gain insight from external expert with MSL （Medical Science Liaison） and propose medical strategy. 【Regulatory and / or Organizational Requirements】 Contribute to Strategy and Activity Review Committee meetings. Ensure ethics and compliance. Ensure re－examination by reviewing documents and process. Plan strategically to allow for effective, safe ＆ medically sound global preparation of drug commercialization efforts. Provide input and medical review of all internal and external documentation prepared by Marketing and Public Relations. Define trials needed to answer relevant questions regarding our products and their related development projects to meet regulatory and payer requirements and our commercial needs build upon from the trial’s concepts developed by the Medical subteam and local project team for registration. Provide medical input into epidemiology studies. Ensure communication with CPL （Clinical Project Leader）. Support obtaining preferable pricing. 【Job Complexity】 ・Works in a cross－functional team including MSL, CPL, RA （Regulatory Affairs）, PSPV （Patient Safety ＆ Pharmacovigilance）, BDS （Biostatistics ＆ Data Sciences）, Marketing, and Market Access ・Requires driving cross－functional projects. People management responsibilities may be assigned depending on the candidate’s career background and organizational needs. ・Plays a key role in planning and leading medical education initiatives in collaboration with internal and external stakeholders. 【Interfaces】 Integrated brand team, Local/Global R＆D team members, Medical Affairs subteam, Team member global epidemiology, etc. 【Job Expertise】 ・Full understanding of regulatory, clinical development, medical communication and compliance requirement in Medical Affairs ・Expertise in people management is valued, but not mandatory. Capability to lead teams or works independently in planning and executing medical education initiatives is essential. ・Capability to lead teams in designing and implementing innovative educational programs is essential. 【Minimum Education/Degree Requirements】 Master's degree in life sciences. MD or PhD is preferred. |
| 労働条件 |
契約期間：期間の定めなし 試用期間：あり（3カ月） 就業時間：8:45～17:20（うち休憩45分間） 休日：土日、祝日 その他各種会社休日あり（年間127日：2025年） 休暇：年次有給休暇（入社初日に6～16日を付与）、慶弔休暇・リフレッシュ休暇等各種有休特別休暇制度あり 残業：あり 給与改定：年1回（4月） 通勤手当：会社規定に基づき支給 社会保険：健康保険、厚生年金、労災保険、雇用保険 |
| 応募資格 |
【必須（MUST）】 Required Capabilities （Skills, Experience, Competencies）・TA experience in clinical or research setting, ideally for nephrology, cardiology and endocrinology ・Experience in clinical development and regulatory interactions related to PMDA consultation and NDA filing and product launch are preferred ・Capability to conceptualize research projects, conduct basic and/or clinical research independently, and write scientific papers ・Experience collaborating with and managing key opinion leaders and external experts in relevant disease areas ・Strong negotiation and communication skills for both internal and external stakeholders, in Japan and globally ・Excellent project management and cross－functional collaboration skills, with the ability to work in global matrix teams ・Experience designing, developing, and delivering medical education programs using in－house media or third－party platforms ・Experience leading team projects （evidence generation, new drug launch/approval, collaboration with external stakeholders） ; people management experience is preferred. ・English proficiency （at least TOEIC >800） ・Knowledge of regulations related to clinical research, clinical trials, and clinical development Regarding publications ・Please submit publication's title and Author. |
| リモートワーク | 可 「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります |
| 受動喫煙対策 | 屋内禁煙 |
| 更新日 | 2025/12/19 |
| 求人番号 | 6385819 |
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転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です