【R D】Study Manager BioPharma CO Development Operations Divisi…

【求人No NJB2357115】
■ 職務内容 / Job Description
Clinical Scientist （CS） is a clinical project lead with strong experience in multidisciplinary aspects of drug development and is accountable/responsible for generating clinical development strategy designing clinical development options and delivering successful clinical development programs for responsible AZ assets in Japan.・
His/Her accountability/responsibility is balanced between project level and study level activities depending on his/her experience and expertise in order to achieve deliveries of both projects and studies.・
Other major responsibilities/accountabilities include but are not limited to:
・Co developing the documents for regulatory interactions such as BD for regulatory consultation query responses Sakigake application ODD application etc ・
・Authoring clinical/medical part of CTD and responses to queries・
・Acting as a key point of contact for clinical development related relationship with external experts.・
・Leading development of clinical science part of clinical trial documents and providing support for the Study Level Safety Review activity for Japanese standalone development projects
・Inputting to publication strategy and contents/quality of publications.・
・Guiding and supporting other Clinical Scientists at career level D. （Career Level Eの場合）

以下はCareer Level D/Eに対する要件でございます。

■ 応募資格（経験、資格等）/ Qualification （Experience Skill etc.）
【経験 / Experience】
＜必須 / Mandatory＞
Experience of working on drug development in pharmaceutical industry

＜歓迎 / Nice to have＞

・Clinical science strategy planning in drug development
・Negotiations with external experts
・Planning of clinical science strategies as a Japan clinical science representative at the cross functional team
・Quality of knowledge on drug development strategy and clinical science
・Experience on negotiation with PMDA/MHLW and getting JNDA/sJNDA approval and supporting launch activities （Career Level Eの場合は必須）

【資格 / License】
＜必須 / Mandatory＞
Life Science related bachelor’s degree required

＜歓迎 / Nice to have＞
Doctor of Philosophy preferred

【能力 / Skill set】
＜必須 / Mandatory＞
・Assertive communication skill
・Medical writing skill
・Project management skill
・Logical thinking skill
・Strategic influencing skill
・Leadership capability
・Conceptual thinking skill
・Negotiation skill
・Ability to work in a complex business critical and high profile environment building credibility in ambiguous situations
・Rapid adaptability to a new environment

【語学 / Language】
＜必須 / Mandatory＞
英語 English： Business English （グローバルチームとの会議を実施できるレベル）
日本語: Native level