人材紹介ヘイズ・スペシャリスト・リクルートメント・ジャパン株式会社／Hays Specialist Recruitment Japan K.K.
メディカル/医薬/バイオ/素材/食品 - 臨床開発系
メディカル/医薬/バイオ/素材/食品 - 製品開発
メディカル/医薬/バイオ/素材/食品 - その他
Your new role
1. Project Administration - Attends Quick Start camp, Quality Finish Camp, and may attend process review and Kick-Off Meetings and other project meetings as required. Participates in Trial Master File audits. Assists in preparation for and attends investigator meetings. Prepares and maintains Study Reference Manual and site reference tools. Drafts and prepares documents for mass dissemination. Arranges for receipt of administrative and regulatory documents. Coordinates the packaging, shipping, and tracking of study supplies and materials. Transcribes accurate meeting minutes and action items to meet the INC specifications of the project team and Sponsor.
2. Reporting - Assists project team with compliance or maintenance of regulatory standards, Standard Operating Procedures (SOPs), and Work Instructions (WI). Maintains current regulatory documentation according to Essential Regulatory Document Guidelines and TMF Plan. Reviews and submits Essential Regulatory Documents for second review. May conduct second review of Essential Regulatory Documents. Prepares and disseminates Investigator regulatory binder.
3. Communication - Maintains timely and effective communication among team members and site staff. Keeps Project Leadership and Clinical Research Associates (CRAs) fully appraised of sites and study status. May contact site staff as needed for critical information.
4. Training – May train new employees assigned to project.
What you'll need to succeed
-BA/BS in the science/health care field, nursing degree
-Minimal Clinical Research/Medical experience
-Basic knowledge of ICH, and drug development process
-N1 level Japanese and fluent English
What you'll get in return
-Through training and support
-Future career path as a Project Manager
-Working in a global environment
Your new company
A game-changing company that is reinventing the way therapies are developed and commercialised. Continuously growing and evolving. Aiming to be the best and only Biopharma Accelerator. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform.
|年収||日本・円 450万円 〜 600万円|