We currently have an exciting opportunity for a Senior Medical Writer, Clinical Evaluation - China available in Beijing. In this role, you will provide medical writing expertise to support marketing applications and post-market surveillance filed with the China National Medical Products Administration (NMPA). Your deliverables include the Clinical Evaluation Report (CER), Periodic Risk Evaluation Report (PRER), and other related regulatory documents. Daily activities are related to authoring CER, PRER and related regulatory documents for Vascular, Structure Heart, Cardiac Rhythm Management, Heart Failure, Neuromodulation, and Electrophysiology products.
WHAT YOU’LL DO
- Writes and contributes to the CERs, PRERs, Regulatory Responses and other related documentation.
- Evaluates and summarizes clinical evidence including data from sources such as clinical investigations, literature, post-market surveillance, risk management, and post market clinical evaluations. Analyzes results in preparation for product applications and submissions to China NMPA.
- Effectively communicates in both English and Standard Chinese/Mandarin and collaborates with team members and stakeholders, in completing clinical evaluation project related deliverables.
- Supports additional clinical, regulatory and related deliverables as assigned.
- Engage proactively in the preparation of and presentation at the meetings with China NMPA.
- Ensures quality in all deliverables and documentation with attention to detail, consistency and integrity of data.
- Maintains thorough knowledge of assigned products. Identifies appropriate sources of relevant data, interprets, evaluates and incorporates information from various sources including literature, clinical data, and medical references.
- Ensures compliance to applicable regulations and guidance’s (ISO13485, ISO14155, ISO14791, China NMPA regulations, NMPA guidance, IMDRF guidance, etc.) and applicable Abbott SOPs and DOPs.
