Nonclinical Regulatory Management Expert

募集要項

仕事内容

（雇入れ直後）
•Support and guide project personnels to plan and execute the nonclinical strategy in regulatory application, based on the background of scientific expertise in a specialized field (pharmacology/pharmacokinetics/toxicology) in cooperation with divisional Directors.
•Contribute to collecting and analyzing information related to global nonclinical applications. and provide it to project personnel as appropriate.
•Create application-related documents by exerting the expertise.
•Review and support to revise the application documents which drafted by project personnel.
•Contribute to providing educational input to personnels within and outside the department on nonclinical regulatory works.
•Identify issues for productivity in nonclinical application-related works and solve them in cooperation with divisional Directors.
•May play roles of NCRM-L as well as roles of Research Lead for late-stage programs.
•May play operational roles in Division under delegation from Vice President and Senior Director.
•May participate external industry activities as a representative of Research.

応募条件

【必須事項】

•More than 10 years of nonclinical research experience or equivalent
•Substantial experience with over 8 years of nonclinical application works, including preparation of application documents.
•Willingness to perform and improve application-related works.
•Good logical thinking.
•High communication and leadership abilities.
•Advanced science degree (PhD) or Proven track record.

【歓迎経験】

•Substantial experiences on nonclinical works for obtaining approval of new drug application and/or clinical trial application.

【免許・資格】

【勤務開始日】

応相談

学歴

大学院博士以上

雇用形態

正社員

試用期間

試用期間原則なし

勤務地

転勤の有無

転勤なし

受動喫煙防止措置

屋内禁煙

勤務時間

フレックスタイム制
フルフレックス（コアタイムなし）
本社：8:45～17:45（月～木）、8:45～16:00（金）

勤務開始日

応相談

休日休暇

完全週休2日制
年間有給休暇：　
法定休暇：年次有給休暇、産前産後休暇、介護休暇
特別休暇：夏季休暇、年末年始休暇
その他休暇：祝日、5月1日　育児休業制度

年収・給与

年収　　800万円～　経験により応相談

諸手当

裁量労働手当、住宅手当、通勤手当　等

昇給

あり

賞与

あり

採用人数

若干名

待遇・福利厚生

通勤手当：有
寮・社宅：有
住宅手当：有

各種制度

雇用保険：有
労災保険：有
厚生年金：有

選考プロセス

１）書類選考
２）一次面接
３）適性検査
４）最終面接