職位描述
•Coordinates and leads the writing of clinical technical documents•Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. •Coordinate and conduct interdepartmental team review and sign-off of document deliverables•Perform literature reviews as necessary•Review statistical analysis plans and mock statistical output to assist in determining appropriateness of content/format for clinical writing.•Serves as an mentor to junior staff members •Serves as primary technical contact with client•Develops and implements training•Initiates and manages development of formats, templates and general guidelines for clinical documentation and workflow procedures •Assists in the development of departmental SOPs, and monitors team compliance to SOPs•Participates in departmental or interdepartmental process improvement•Performs other tasks as directed by the line manager Applied Knowledge and Skills:1. Acts as a Lead medical writer.2. Provides lead for Business Development opportunities.3. Considered an expert in core WuXiPRA systems (e.g. eTMF, CTMS, and ART, where appropriate in current work assignment) 4. Considered an expert in core WuXiPRA processes; is a mentor for less experienced staff on any aspect related to processes and systems. 5. Provides training and input to develop training materials.6. Contributes to reports for internal / external audiences Excellent communication with internal / external audiences 7. Develops concise and clear schedules and communicates to team members as appropriate
