求人・転職情報

■Education(minimum/desirable):
Degree in Life Sciences, Pharmacy or Medicines. Advanced degree a plus.

■Languages:
Fluency in English (oral and written)

■Experience/Professional requirement:
１．+7 years of involvement in regulated activities (GCP/PV), clinical development and/or QA positions.
２．Broad understanding of global expectations of Health Authorities in the area of Clinical Development and profound understanding of the science of product development.
３．Ability to work independently and in a global/matrix environment.
４．3 or more years’ experience in managing projects.
５．Ability to effectively interact with and present to senior management at all levels, as well as to external audiences and inspectors.
６．Strong skills in GCP, quality and/or clinical development.
７．Strong interpersonal, communication, negotiation, and problem solving skills.

【経験 / Experience】
＜必須 / Mandatory＞
'-Leadership of significant cross-functional change programmes/initiatives with Proven courageous leadership consistently challenging the status quo and promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives.
-At least 5 years’ experience in the pharmaceutical industry including at least 3 years’ experience in Clinical Development / Assurance / Advice
-Well-informed understanding of drug development process and related GCP activities and understanding of skills and knowledge required for successful delivery of a clinical trial, e.g. GCP, monitoring, data management, study drug delivery etc.
-Proficient knowledge of local and international regulations and guidelines
-Knowledge of Clinical Procedural Documents

＜歓迎 / Nice to have＞
'-Process Management including developing / reviewing Procedural Documents in Japanese / English
-Professional excellence: Background of high professional achievement and willingness to encourage this in others
-Experience in leading or being involved with Business Process Management

【資格 / License】
＜必須 / Mandatory＞
Bachelor’s degree (or equivalent), preferably in biological science or discipline associated with clinical research.

＜歓迎 / Nice to have＞
MBA, Project Management Professional(PMP)

【能力 / Skill-set】
＜必須 / Mandatory＞
'-Leadership
-Excellent written and verbal communication skills, negotiation, collaboration and interpersonal skills in a multicultural environment
-Integrity and high ethical standards
-Manages change with a positive approach to the challenges of change for self, team and the business. Sees change as an opportunity to improve performance and add value to the business. 
-Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
-Makes effective decisions despite uncertainty and/or incomplete information.
-Communicates clearly to ensure alignment and empowers others with decision-making authority as appropriate.
-Seeks diverse views and incorporates them where appropriate in order to develop better proposals and creative solutions for the business.

＜歓迎 / Nice to have＞
Consistently exhibits Leadership capability as below
-Commitment to Customers & Integrity; Focuses on What’s Important: Balances and prioritizes across diverse and competing customers, needs and opportunities. 
-Demonstrates the courage to make tough and ethical decisions about where to devote resources.