Skip to main content

求人検索

プロフィールを使用して検索

RA Intelligence Manager

応募 後で応募 求人ID R0006463 掲載日 01/02/2019 Location:Shanghai, China

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that I agree with Takeda’s Privacy Notice, Privacy Policy and Terms of Use.

Job Description

OBJECTIVE

1. Collect and analyze the latest policies, provide professional interpretation timely

2. Establish and maintain strong, effective working relationships with HA professionals, be able to predict the trend of national policy, and assist Takeda in formulating strategic directions from RA insights

3. Combine with Takeda pipeline to work out the specific strategic plan and provide the professional inputs

4. Industry analysis/monitor and influence, including but not limited to, competitors, industry events influence from Takeda etc.

ACCOUNTABILITIES

Monitoring the requirements of HA, including but not limited to, regulation/guideline update, feedback from industry, etc. and generate analysis reports periodically to distribute cross-functionally. Collect and analyze regulatory information, such as, review and approval timeline of CFDA/CDE, priority review and on-site inspection lists, competitors including GQCE and develop evaluation report in a regular manner. Interpret regulations timely after release, conduct impact analysis and support strategy developing accordingly. Organize discussion for comments collection of draft regulations from RDPAC , and send feedback as requested. Effectively participate in associations (e.g., PDPAC, PhRMA), to establish and maintain strong, effective working relationships with HA professionals. Provide qualified, regulatory advice to the team, to make sure the regulatory activities are under the latest requirements of HA. Provide training sessions of latest regulations within Takeda cross-functional team. Prepare meeting materials and documents according to department needs. Others assigned by line manager.

KEY RELATIONSHIPS

Internal

GRA,TJT-P, Marketing, Access Excellence, TDC, etc.

External

RDPAC, PhRMA, CFDA, CDE, NIFDC, etc.

QUALIFICATIONS

Level of Education

Bachelor degree or above, medicine or pharmacy related major

Working Experience in Relevant Field

>=5 years of related work experience;

Professional Knowledge and Skills

Be familiar with the laws and regulations on drug administration and registration management.

Excellent communication skills, both verbal and written. Proficiency in English is a must.

Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation and database applications.

Locations

Shanghai, China

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

応募 後で応募