Medical Writing

•  Creates clear, accurate, and regulatory-compliant documentation related to clinical submissions.

•  Manages the interpretation of clinical research, data collection activities etc.

•  Establishes scientific methods for design and implementation of clinical protocols, data collection systems and final reports.

•  Work closely with cross-functional teams (Regulatory, Clinical, Quality, Marketing etc) ensuring successful preparation of high-quality submission-ready clinical documents such as clinical evaluation documents, Pre-/Post-Market Clinical Follow-up documents, and other Clinical Study documents. 

•  Translate complex scientific and technical information into accessible content for various audiences.

•  Requires mastery of a specialized field of expertise that typically requires a college degree or equivalent.

•  Requires professional knowledge gained through substantial applicable work experience, to supplement formal knowledge, in order to apply principles and concepts of own subject/technical discipline in resolving issues

Clinical Operations

•  Monitors assigned clinical trials to ensure data integrity and adherence to China regulations, company policies, and any other applicable procedures.

•  Primary point of contact with site staff, and is responsible for managing the site throughout all phases of the clinical study, including selection and initiation of sites, as well as conducting and closing activities of the appointed studies.

•  Establishes cross-functional and KOL relationships, monitors and/or supervises the monitoring activities of assigned clinical trials to ensure data integrity and adherence to China regional regulations, company policies, and any other applicable procedures.

•  Responsible for supporting compliance with applicable Regulations, ICH/GCP principles, Stryker SOPs, and timely completion of complex global neurovascular studies

• Bachelor's level degree or equivalent in science or health care field with at least 4 years of relevant clinical research experience specifically in monitoring.

• Preferred experience in Device or Pharmaceutical industry.

• Experience as a Clinical Research Coordinator, Clinical Trial Coordinator or Clinical Research Associate preferred.

• Understanding and experience in the use of scientific journals, publication guidelines, databases, search strategies, literature management software

• Good knowledge and experience with NMPA clinical evaluations and clinical study documents required.

• Must be able to think analytically, with the ability to interpret data from scientific literature and clinical studies and synthesize the results in a clear, concise, and scientific manner

• Demonstrated ability to work effectively with cross-functional internal (Regulatory, Marketing, R&D) and external stakeholders (Physicians, CROs, etc.) across multiple businesses.

•  Ability to apply ISO, NMPA and related guidelines toward writing strategy and documentation required.

•  Ability to plan, organize, and implement multiple concurrent tasks.

•  Must demonstrate the ability to effectively communicate up/down

• Analytical and problem-solving capabilities with the ability to draw insights from data quickly and to define executable actions.

•  Fluent in both verbal and written English (CET-6 or equivalent minimum), with the ability to draft and review regulatory documents (e.g., Clinical Evaluation Report, Clinical Study Report) independently in compliance with industry standards.

•  Fundamental knowledge and good understanding of GCPs, clinical study development process, and logistics required.

•  Demonstrated independence in performing site monitoring (e.g. site selection, site initiation, interim monitoring and closeout visits) and site management activities.

• Ability to apply NMPA, ISO, and related guidelines toward documentation. 

• Strong interpersonal, written and oral communication, organization, and planning skills.

• Team based work experience preferred.

• Working knowledge of personal computer systems and desktop office applications

• Proficient in systematic literature searches (PubMed, Embase, etc.), appraisal, and synthesis of clinical data to support ​​Clinical Evaluation Reports (CER)​​ writing per ​​NMPA guidelines​​.

• Resilience and accountability to ensure project excellence and project delivery from Medical Writing and Clinical Operations perspectives

• CCRA Certification preferred.

• Regulatory Affairs experience is a plus

• Project Management Certification is a plus