Johnson & Johnson Careers
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Manager, Training and Complaince
Requisition ID: 1805638225W
Principle Duties and Responsibilities (General summary, essential functions and authorities, etc.)
The overall purpose of the position is to ensure the quality system of clinical research and medical affairs in China and venders who provide services are compliance with GCP, CFDA regulations, J&J policy, company GOP/SOP and related working procedure.
Clinical Research and Medical Affairs Quality System Setup and Maintenance:
1) Set up and maintain the quality system in China medical affairs and clinical research department to meet regulatory expectations and business need. Manage and recommend changes to existing procedures where applicable
2) To be expertise of local regulations and standards and ensure necessary requirements are transferred and built into the clinical research and medical affairs SOP system.
3) Help to interpret relevant regulations and guidelines and act as a contact person of clinical research quality in China.
Clinical Research and Medical Affairs Quality Control
1) Perform ongoing monitoring and risk assessment of medical affairs and clinical research quality to identify performance/compliance gaps relative to current regulations and recommend corrective actions. Escalate significant issues to management.
2) Set up and manage the clinical research and medical affairs quality plan.
3) Prepare regular quality, trends and metrics reports.
4) Define and conduct quality assessment in accordance with the quality control plan defined for China clinical research and medical affairs.
5) Provide quality check on clinical research essential documents, including protocol, ICF, CRF and study reports
. Qualifications and Training
1) Coordinate the review and update of job descriptions and training curriculum maps.
2) Verify that curriculum vitae, job descriptions, curriculum maps and training records are adequate and appropriately filed.
3) Quality checks the activities of clinical operation team in China or contracted CROs regularly.
4) Initiate and organize clinical research and medical affairs training program.
5) Support the role out and implementation of clinical research and medical affairs SOPs to ensure staffs are clear on changes, new requirements and define process for implementation.
Audit and Inspections
1) Lead and facilitate audits and inspections
2) Coordinate audit and inspection response and consult on root cause analysis.
Project Management and Process Improvement
1) Support the implementation of process improvements and provide feedback on effectiveness of implementation, challenges and best practice. Feedback potential solutions.
2) Share key learning to drive simplification and replicate best practices. Actively participate in team meetings
Other responsibilities defined in written procedures.（流程中规定的其它职责）
– At least with bachelor degree of medicine/pharmacy/other healthcare disciplines
– At least 6 years’ experience in clinical research, including at least 2 years project management experience
– Excellent knowledge of ICH GCP guideline, local and global SOP and local regulations.
– Knowledge of clinical interfaces such as GMP, GSP, GLP and ISO.
– Able to work effectively with all levels of the organization
– Able to separate critical from non-critical issues.
– Strong people communication skill
– Fluent in English speaking, reading and writing.
– Good teaching and coaching skills
– Good presentation skill
– Good problem solving skills and initiatives
– Global perspective
– Good project management skill (e.g. good planning, implementation and follow up) is required
– People management experience is a plus
Johnson & Johnson Medical Shanghai Ltd. (7055)