Ref #: 26876

Employment type: Permanent - Full-Time

Location: China-Beijing/Shanghai

Description

PRINCIPAL RESPONSIBILITIES:
• Prepares basic clinical documents under close supervision such as, but not limited to, Phase 1 protocols, Phase 1/2 CSRs, table of studies, narratives, protocol amendments, initial IBs, IB addenda. Documents must be of high quality in terms of scientific content, as well as organization per regulatory and internal guidance, clarity, and accuracy, with attention to format and consistency.
• Helps prepare sections of more complex clinical documents under close supervision (eg, IB updates, Phase 2/3 CSRs and appendices, RMP annexes, protocol T&E schedules).
• Performs document QC, abbreviations, references, literature searches, table creation, and other basic tasks with some supervision.
• Participates in cross-functional document planning and review meetings.
• Works in a team environment with some guidance provided, and takes a somewhat active role (under close supervision) on assigned projects with respect to timing, scheduling, and tracking.

ADDITIONAL RESPONSIBILITIES:
1. Learns and adheres to SOPs, templates, best practices, policies, Medical Writing Style Guide.
2. Regularly meets with manager and mentors, and attends departmental meetings.
3. Attends cross-functional meetings with other writers as appropriate (eg, project kick-off and review meetings).
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4. Completes all time reporting, training, and metrics database updates as required.