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.

REQUIRED:

Full professional working proficiency in both English and Standard Chinese/Mandarin

Bachelor’s Degree with 4+ years of medical writing experience in the medical or pharmaceutical industry or 7+ years general technical writing experience required

Experience may include writing experience in a medical, pharmaceutical, medical device, clinical research, medical or research industry , or combination of these skills

Excellent written and verbal communication skills

Strong commitment to meeting timelines

Proactive learner and self-motivated worker

Flexible to accommodate US working hours as needed

Willingness to take ownership

PREFERRED:

Advanced degree(s) in biomedical, sciences, medicine, clinical/mechanical engineering, regulatory affairs, or related fields preferred

CER writing experience preferred

Experience with collaborative, cross-functional teams

Excellent analytical skills and ability to manage complex tasks and manage time effectively

Proficient with Microsoft Office 365