・To lead Quality Assurance group developing talents
・To operate appropriately quality events in compliance with global CSLB policies and
local regulatory requirements
・To collaborate with internal partners, such as global QA, manufacturing sites, local
・To communicate with the local health authorities and external parties
・To establish new simple and clear governance model in accordance with the global
【Main Responsibilities and Accountabilities】
1. To Lead QA group and Perform rou ...
A leading manufacturing company is searching for a Contract Pricing Analyst. The person who enters this position will be responsible for creating and assessing fair pricing for clinical trial contracts.
* Review pricing requests
* Utilise regional marketing and pricing guidelines to assess investigator grants
* Take part in budget escalation review
* Identify budget revision and contract changes
* Conduct virtual training for global colleagues
* Oversee pricing documentation and tracking
【Establishment of genomic research (fertilized egg production)】
●Basic/applied research/development (chemical experiment, bio experiment, etc.)
●Molecular biology experiment
● Algorithm development for economic and genetic traits
● Data aggregation and statistical analysis that required scientific knowledge
●Various inspection work, reagent adjustment
● Image and video analysis ...
◆ Job description
You will be in charge of overseas regulatory application for in-vitro study drugs. In collaboration with the parent company, we decided to hire a full-time person in charge of expanding sales in the Middle East and Asia, where significant growth is expected in the future.
◆ Position of the company
In the biochemistry field, we have a domestic market share of over 30%. Traditionally, we have been supplying OEMs to overseas top manufacturers, and our products are used all over the world. As the quality of our products is recogniz ...
In addition to preparing documents (such as applications and negotiations) to be submitted to the Ministry of Health, Labor and Welfare, we also create and revise product manuals.
The manufactured products are checked against the Pharmacy Law (formerly the Pharmaceutical Affairs Law), and quality control is performed to check whether there are any structures or notations that may cause problems.
In addition, we work with authorities such as the PMDA and global clinical trials.
We have many transactions with overseas companie ...