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Medical Compliance & QA Head

Job ID R0005467 Location Beijing, Beijing Municipality, China; Shanghai, Shanghai Municipality, China;

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Job Description

PURPOSE

Lead the team to establish medical compliance systems, continually identify areas for ongoing process improvement, and establish systems to streamline ways of working. Guide marketing and medical activities to be undertaken in a compliant and ethical manner. This role will also work closely with Emerging Market team to promote the quality management, compliance, inspection readiness, training process improvement to ensure the high quality performance of medical operations in Greater China.

RESPONSIBILITIES

1.    Review and approval of materials and activities, including, but not limited to, product-related promotional materials, meeting invitations, presentations, patient and medical educational materials, advisory board meetings and non-promotional materials produced by commercial team and/or medical team in accordance with local regulation and Takeda internal standards, ensuring consistency with product license.

2.    Ensure compliance with meetings/ materials review and approval process

3.    Inspect periodically and optimize the relevant internal process

4.    Maintain a customer-focused perspective on promotional regulatory matters and lead Takeda China adaptation to a changing promotional regulatory environment from a medical perspective.

5.    Education of Takeda China in required standards for promotional/ non-promotional materials and activities as required.

6.   Act as a quality control for all scientific material produced by the China Commercial Teams, checking accuracy of references, sources, statements and data prior to distribution internally across the commercial organization, or externally.

7.    Lead the medical relevant SOP creation and maintenance to make sure all the SOP are updated.

8.    Be responsible for administering regional SOP, Implementation Guideline and ensure the required documents are appropriately documented according to SOP.

9.    Maintain the tracking form, management folder and Medical Governance functional.

10.   Work as a contact window and make a well/smooth relationship with quality department/ QA function of Global Medical Affairs and EM QA/Compliance function to make sure the global guidance is properly aligned in LOC.

11.   Lead the team to setup the tracking scheme on compliance of medical related trainings

KEY RELATIONSHIPS

Internal    All functions of Takeda

External  Local vendors

QUALIFICATIONS

Level of Education     

University Degree in Medical or Pharmacy, Master degree is preferable.

Working Experience in Relevant Field

Minimum 8 year’s related working experience in pharmaceutical company. Related experience with SOP making and training implementation. Experience of complex project management in multinational company. Experience of conducting an audit process and developing quality management plans.1-2 year’s people management experience is preferable.

Professional Knowledge and Skills 

Thorough knowledge of ICH GCP and related local regulations, understanding of the processes and regulatory requirements related to clinical trial, RA, medical and safety operations.

Excellent teamwork/collaboration.

Pro- active, self- motivated, excellent planning and organization skills and excellent communication & interpersonal skills.

Has strong sense of compliance to clinical guidelines, regulations and protocol.

Able to work under pressure in a busy environment and manage change, excellent problem solving skills.

Good at Microsoft Office.

Excellent English skills in listening, speaking, reading and writing.

Good leadership skill to motivate the team.

Locations

Beijing, China

Shanghai, China

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time