Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world—from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.
Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.
KEY 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 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.
BACKGROUND:
Master’s or bachelor’s degree preferred in Ophthalmology Science or Biomedical Science field or Science.
Preferably 5+ years of experience in managing or drafting role in medical device, at least 1 year of hands-on CER drafting experience.
This position may be available in the following location(s): CN - Beijing.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
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