北京招聘

· Creates / coordinates CERs in English and Chinese according to internal SOPs and relevant regulations.

· Manages timelines and communication to ensure deliverables and milestones are met.

· Ensures compliance with corporate (e.g. SOPs) and regulatory requirements (e.g. NMPA requirements).

· Conducts scientific literature reviews and evaluates relevant data (e.g. clinical study reports, in vitro data).

· Gathers relevant documents for writing of CER and completes relevant documentation.

· Follows a selected number of clearly defined procedures under general guidance. Handles inquiries of moderate scope and complexity.

· Designs and writes technical documentation.

· Conforms to department standards of formatting, information design, and usability. Uses appropriate tools and software programs for writing and publishing documents based on the project and industry standards.

· Serves on cross-functional teams responsible for product development, attends team meetings, and maintains open communication between the team and other departments. Edits work for other writers. Fosters a respectful, cooperative work environment.

· Follows a variety of clearly defined procedures under general guidance. Works independently, although the scope for discretion is limited and the output is reviewed periodically while in progress. The work priorities are defined with the manager/supervisor.

· Uses relevant theories and practices to provide guidance and/or training to support level co-workers within the same or job-related work group.

· Handles inquiries of moderate scope and complexity. Uses basic analytical skills to interpret information, examine variables, draw conclusions, and assess alternative methods. Most complex problem solving may require the use of increased judgment to handle some variations in conditions or operations, making decisions based on selecting from alternative courses of action using greater adaptation to circumstances when necessary.

· Decisions or actions may impact the operational effectiveness of work operations, schedules, or performance goals

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