Key Responsibilities:
1. Senior-Level Clinical & Regulatory Medical Writing.
2. IIT & Post-Market Clinical Research Support.
3.Documentation Quality Control & Cross-Functional Leadership.
4.Regulatory Intelligence & Process Optimization.
Qualifications
Education
Bachelor’s degree above in Clinical Medicine, Biomedical Science, Pharmacy, Public Health, Life Sciences, related fields.
Master’s degree above is strongly preferred.
Experience
5+ years of hands-on experience in medical writing, clinical research, regulatory documentation in the pharmaceutical medical device industry.
Proven experience in registration clinical trials, IIT, and/post-market clinical studies.
Experience in aesthetic medicine,thopedics, trauma, sports medicine, implantable medical devices is highly preferred.
Solid working knowledge of EU MDR, FDA, NMPA, ICH-GCP.
Core Competencies
Advanced medical regulatory writing skills in both English Chinese.
Fluent English listening, speaking, reading, writing as a daily working language.
Ability to independently manage complex, multi-project clinical documentation with minimal supervision.
Strong regulatory interpretation ability exceptional attention to detail.
Excellent cross-functional communication stakeholder coordination skills.
High level of professionalism, accountability, confidentiality.
Preferred Qualifications
Experience with real-world studies (RWS/RWE) large-scale post-market surveillance programs.
Direct experience supporting FDA, EMA, EU Notified Body interactions.
Experience with global multi-center clinical trials.
Priexperience in inspection preparation regulatory audits.
Working Language
English is the primary working language.
Career Development Path
Principal Medical Writer
Medical Affairs Manager
Clinical & Regulatory Strategy Lead
Global Clinical Documentation Expert
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