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PRINCIPAL RESPONSIBILITIES: ? Helps prepare sections of documents or write basic documents under close supervision such as table of studies, narratives, simple protocol amendments, simple IB updates, IB addenda. ? May assist with document QC, abbreviations, references, literature searches, table creation, and other basic tasks. ? Attention to accuracy, format, and consistency. DECISION-MAKING AND PROBLEM SOLVING: Describe the types of decisions that are made, reviewed or referred. Describe the types of problems solved or referred. Indicate the degree to which decisions made and problems solved are circumscribed by procedure, policies, standards, or regulations. RESPONSIBILITY FOR OTHERS: 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). 4. Completes all time reporting, training, and metrics database updates as required.