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Hiring Company | 急成長しているバイオベンチャー |
Location | Tokyo - 23 Wards |
Job Type | Permanent Full-time |
Salary | 8 million yen ~ 15 million yen |
Company:
Fast-growing bio-venture
We are developing pharmaceutical products specializing in the areas of "cancer, blood, and autoimmune diseases."
The company is working on the development of new drugs that focus on the “blank treatment area” that is expanding with structural changes in the pharmaceutical industry, and aims for sustainable growth as a company through activities that meet unmet medical needs.
Position:
As a manager of the CMC department of a listed (TSE Growth) pharmaceutical company, you will be involved in the following operations.
(1) As a person in charge of the investigational drug supply department related to the development theme, you will be involved in the investigational drug supply business in line with the clinical development plan
(2) Formulation and execution of a technology transfer plans in cooperation with related parties inside and outside the company and related departments.
(3) Application / notification of approval or change (creation of CMC related documents)
(4) Provide necessary CMC support for the internal departments related to product maintenance.
Treatment:
Health insurance, welfare annuity insurance, employment insurance, workers' accident compensation insurance (social insurance: Tokyo Pharmaceutical Health Insurance Association)
Commuting allowance: 6-month commuter pass
Severance pay system: Defined contribution pension (~ 60 years old), Contribution reserve (60 years old ~)
72 years old
■ In-house study session
■ In-house training (invited lecturer)
■ OJT
■ Attendance of external training
■ Comprehensive welfare group term life insurance
■ Health checkup assistance: As a general rule, various checkups designated by the health insurance company will be fully borne by the company, and the human dock will be subsidized up to 10,000 yen.
■ Empliyee Stock Purchase System: Incentive 8%
Minimum Experience Level | Over 6 years |
Career Level | Mid Career |
Minimum English Level | Business Level |
Minimum Japanese Level | Fluent |
フレックスタイム制:10:00~15:00 標準的な勤務時間帯:9:00~17:30 休憩時間:60分間 | |
Minimum Education Level | Bachelor's Degree |
Visa Status | Permission to work in Japan required |
Experience: CMC (formulations, especially injectables) related development, manufacturing, analysis work, CMC for domestic and international applications
Document writing experience
Knowledge: Knowledge of Pharmaceutical Machinery Law, related laws and regulations, GxP (GMP / GQP / GDP), JP, USP, EP, ICH, etc.
Ability: Ability to negotiate with contractors and partners, ability to manage schedules for collaborative work
Basic communication skills with foreign companies in English are required
Job Type | Permanent Full-time |
Salary | 8 million yen ~ 15 million yen |
Holidays | 完全週休2日制(休日は土日祝日) 年間有給休暇1日~15日(下限日数は、入社直後の付与日数となります) 年間休日日数124日 |
Industry | Pharmaceutical |
Company Type | Small/Medium Company (300 employees or less) |
Non-Japanese Ratio | Majority Japanese |