OBJECTIVES/PURPOSE OF JOB： Takes responsibilities for China CER (clinical evaluation report) drafting, monitoring worldwide on-going clinical trial progress to support China CER strategy, support to potential CER in Japan, medical letters to other markets in APAC. Participates in relevant key projects technical/clinical discussion. Interacts extensively with internal clinical and medical leadership and manages all aspects of external CER vendors’ relationships.
KEY ACTIVITIES/RESPONSIBILITIES： 61 Works collaboratively with Regulatory Affairs (RA), Clinical Development (CD) and Medical Affairs (MA) to evaluate/provide strategic clinical evaluation approach for product new registration (or variation registration if clinical evaluation required) to avoid or minimize a repetitive clinical trial. 61 Works with internal RA/Marketing/MA/Clinical experts to train CER vendor on product attributes (if necessary) before CER drafting. 61 Collaborates with internal (clinical development department, RA project owners, study managers, statisticians, business peers, post-market surveillance, etc.) and external (CER vendors, clinical consultants, subject matter experts, regulatory agencies) partners to ensure comprehensive analysis of clinical evidence. 61 Works as product introduction presenter during CER vendor bidding process. 61 Works effectively with internal and external partners to develop high-quality clinical evaluation report under aligned timeline. 61 Reviews and approves CER documentations. 61 Ensures appropriate evaluation and presentation of the data, methodology and interpretation. 61 Support clinical development expert and RA to answer Health Authority questions during filling review and technical review process of product registration. 61 Reviews, assesses and revises relevant procedures and SOPs regarding efficiency, workflow and implementation. 61 Performs other duties as assigned.
EDUCATION： Master’ or bachelor’ degree preferred in Ophthalmology Science or Biomedical Science field or Science
EXPERIENCE/ COMPETENCIES： Preferably 5+ years of experience in managing or drafting role in medical device, at least 1 year of hands-on CER drafting experience.
