Career Category

Job Description

• Serve as Amgen business process owner (BPO) for HGRAC Management Process (from initial application compilation through to study closure).
• As Amgen HGRAC BPO, be responsible to develop  and maintain Amgen HGRAC SOPs/Work Instructions working closely with Amgen QCA (Quality, Compliance & Audit) team and identified BPOs.
• Lead/project manage and /or participate to provide input on relevant Amgen tasks force teams related to HGRAC activities, as assigned by line manager.
• Be responsible for interpretation of HGRAC regulations and implementation guidelines following consultation with HGRAC officers.
• Set up and monitor key performance metrics on HGRAC-related activities and HGRAC compliance
• Develop CAPAs to address any performance and compliance gaps identified,  in collaboration with QCA function
• Develop and deliver training on an ongoing basis to key stakeholders involved in the HGRAC process.
• Serve as Amgen China SME for all HGRAC-related activities, working with various local and global cross-functional stakeholders and respective study team leads to ensure the HGRAC applications are conducted in a timely and compliant manner.
• Perform Amgen internal review of HGRAC applications prior to submission.
• Provide oversight on HGRAC submissions across China study portfolio, lead timely communication of status  and issues effectively to Amgen HGRAC governance team.
• Perform Amgen internal review of HGRAC annual self-check report prior to submission.
• Provide SME input for HGRAC-related inspections
• Coordinate HGRAC quality improvement initiatives in collaboration with QCA function
• Develop and build relationships with HGRAC officers, serve as Amgen primary POC with HGRAC.
• Participate on appropriate professional and continuing education trainings externally available and internally organized at Covance to continuously build knowledge and expertise on HGRAC-related requirements.

Key Competencies

• Effective leadership skills
• Ability to work in cross-functional teams  and exhibit strong collaboration skills
• Ability to manage team(s) to accomplish increasingly complex, specific projects.
• Ability to influence and motivate others outside of direct line of authority.
• Ability to interface effectively with all levels.
• Ability to navigate through a complex team or matrix environment.
• Effective meeting management.
• Quick learner, proactive, takes initiative.
• Skilled in understanding highly ambiguous situations.
• Results oriented and goal driven.
• Strong oral and written communication skills.
• Ability to organize, interpret communicate and present information effectively.
• Strong problem-solving skills.
• Able to develop creative output based on interpretation and analysis.
• Excellent organization and planning skills with an attention to detail.
• Ability to work independently.
• Demonstrates willingness to put an extra effort when necessary to pursue tasks to conclusion.

Preferred Qualifications

• BA/BS/BSc in life science or relevant
• Minimum 8 years of  experience within Pharmaceutical/CRO industry, with  prior clinical operations /drug development experience; minimum  2 years of HGRAC submissions experience
• Excellent written and oral communication skills in both English and Mandarin

Knowledge (China-Specific)

• Advanced knowledge of clinical trials management including regulations, guidelines, and clinical trial processes

• HGRAC Regulations
• Extensive knowledge of ICH/GCP regulations and guidelines.