Supervises and manages a team of Medical Writers to deliver clinical evaluation documents to support product registration and approvals in China.

Ensures Medical Writers are adequately assigned to deliverables. Reviews and writes, if needed, clinical evaluation and other regulatory deliverables.

Provides guidance and training to Medical Writers and other personnel as needed on the clinical evaluation process, China NMPA regulations, NMPA guidance documents and on Abbott procedures, work instructions and templates related to clinical evaluation.

Interacts with the Clinical Evaluation Project Managers and China Regulatory Affairs to confirm regulatory strategy for, and timing of, submissions to China NMPA. May also interact with the Global business unit stakeholders to gain clarity on deliverables needed for CERs and other regulatory documents.

Collaborates in drafting new or in revising existing templates and procedures.

Engages proactively in the preparation of and presentation at the meetings with 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.

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 6+ years of medical writing experience in the medical or pharmaceutical industry experience required; Experience may include writing experience in a medical, pharmaceutical, medical device, clinical research, medical or research industry , or combination of these skills

Experience as a manager with direct reports and/or oversight of project teams.

Proactive learner and self-motivated worker

Flexible to accommodate US working hours as needed

Must be able to effectively manage multiple projects and timelines

PREFERRED:

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

Contributor and/or review of CER content (CER writing experience strongly preferred)

Preference for management experience over CER activities

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

Proficient with Microsoft Office 365