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:
? 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.
? Works with internal RA/Marketing/MA/Clinical experts to train CER vendor on product attributes (if necessary) before CER drafting.
? 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.
? Works as product introduction presenter during CER vendor bidding process.
? Works effectively with internal and external partners to develop high-quality clinical evaluation report under aligned timeline.
? Reviews and approves CER documentations.
? Ensures appropriate evaluation and presentation of the data, methodology and interpretation.
? Support clinical development expert and RA to answer Health Authority questions during filling review and technical review process of product registration.
? Reviews, assesses and revises relevant procedures and SOPs regarding efficiency, workflow and implementation.
? 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.