メディシン第1部長/部長職/医薬開発本部クリニカルデベロップメント・メディカルアフェアーズ心・腎・代謝領域メディシン第1部
Boehringer Ingelheim
**Basic purpose of the job**
To contribute to global clinical drug development by executing CDMA activities in Japan according to TA strategy between start of preclinical development and late stages of commercialisation
**Accountabilities**
Contribution to Clinical Development Plan (CDP) between start of preclinical development and late stages of commercialization aligned with global development and medico-marketing strategy
**Related performance indicators**
CDP contributions confirmed at HPSC
Ensure Japanese submission and registration are appropriately handled and obtained
**Related performance indicators**
Timely submission and registration
Ensure to prepare and execute IBPs (e.g. PMO plan, Data building, medico-marketing, publication, EEE )
**Related performance indicators**
To conduct MR training in order to improve knowledge level of MR, based on request from training department
Responsible for TA budget control, Management of staff in TA, contribute to Japanese drug development by developing and providing staff for NBI functions (eg. CPL, TA) and for global functions (eg. TMM, TMMA)
**Related performance indicators**
Ensure proper staffing and adhere to effective cost management according to budget
Ensure all the projects are correctly managed in timeline and quality
**Related performance indicators**
Achieve project milestone contributions according to the plan agreed with Core Team
Ensure re-examination by reviewing documents and process, ensure benefit/risk evaluations of products in TA
**Related performance indicators**
Ensure successful re-examination and availability of adequate benefit / risk evaluations at all documents for all products and projects
Support subordinates to develop his/her expertise, Competencies, international communication skills etc.
**Related performance indicators**
Provide subordinates with development opportunities
Support subordinates to create/develop his/her develop career plans
Secure the successor of the position
**Regulatory and / or Organisational Requirements**
Ensure ethics and compliance. Provide timely updates of NBI pipeline information across NBI organisation. Ethical conduct of HCP interactions in TA. Ensure adherence to purchasing guideline in TA initiated contracts. Talent management. Serve as contact for local Communication Department
Output documents
Quarterly TA update report, contributions to CDP/IEP, updated cost tracking sheets, updated OBI reports from CTMS, Talent Management, local integrated brand plans
**Job Complexity**
Work in a cross-functional team, global TA, respective Business Unit
**Interfaces**
Integrated brand team, rapid response team, MST, MAST, TMMA, TMM, Team Member Global Epidemiology, local R&D team members, JPT
**Job Expertise**
Full understandings of regulatory and compliance requirement in clinical development and medical affairs
**Minimum Education/Degree Requirements**
Bachelor of Science
**Required Capabilities (Skills, Experience, Competencies)**
BI Japan in-house coaching skill (BI Japan 社内コーチングスキル)
TA experience in clinical or research setting with own publications, 5+ year’s industry experience in Japan in Clinical Drug Development. Leadership. English speaking.
Required English speaking CEFR level : C1
Recruiter:Tomatsu
All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
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