In this role, you have the opportunity to- Provide Chinese clinical strategy for NPI; Lead the clinical plans development to be compliance with GCP, the regulation, Philips harmonized clinical SOPs;
- Lead the clinical evaluation projects across the product lines, work closely with Regulatory team, product team, marketing team to develop robust and rational clinical evaluation strategy; Ensure the clinical evaluation projects successfully accomplished on time and on quality;
- As key scientific reviewer to assess the scientific and ethical of the company sponsor study & IIS;
You are responsible for
- Participate in the evidence generation processes for NPI & LCM
- Participate in the CDMA(Clinical Development and Market Access) process
- Participate in the development of clinical deliverables, including clinical evaluation reports, clinical trial protocols, CSRs & clinical sections of regulatory submissions
- Working closely with Clin Ops and BS&DM on day to day management of assigned clinical studies
- Supports clinical literature searches and reviews
To succeed in this role, you should have the following skills and experience
Education: Master or PhD in Biomedical Engineering or medicine.
Experience: 3 years’ experience in clinical development function or related clinical area.
Competencies and Skills:
- Demonstrated expertise in NMPA regulatory requirements and clinical data interpretation;
- Effective organizing, communication, and project management skills;
- Effective verbal and written skills in both English and Mandarin;
- Proficient in Biostatistics software is preferred.