Senior Medical Writer - FSP

Parexel FSP has an exciting opportunity for a Medical Writer ! **Key Accountabilities**: **Author Clinical Documents** * Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, and integrated summaries of safety and efficacy. * Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input. * Follow required standard operating procedures (SOPs), templates, guidelines, regulations, client instructions and other processes, as applicable. * Perform literature searches/reviews as necessary to obtain background information and training for development of documents. * Review statistical analysis plans and mock statistical output to determine appropriateness of content/format for clinical writing. **Quality Control** * Ensure that all work is complete and of high quality prior to team distribution or shipment to client. * Confirm data consistency and integrity across the document. * Prepare documents for publishing readiness, when applicable. * Ensure document structure, content, and style adheres to FDA/EMA or other appropriate regulatory guidelines, and comply with departmental, corporate or client SOPs and style guidelines, as applicable. * Provide suggested alternative content when contributors provide content that does not meet document needs. * Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copyediting and content review. **Document Project Management** * Act in the capacity of project manager/lead for medical writing projects, which may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project\-related issues. Project management of contractual and financial aspects may only be performed with the guidance of medical writing management. * Serve as the Medical Writing representative on assigned project teams and demonstrate document leadership: communicate content requirements, coordinate and conduct interdepartmental team review of draft and final documents, schedule and lead/facilitate authoring team meetings to agree on expectations, evaluate progress on tasks, identify issues and facilitate resolutions, manage/drive the timeline, and advance document development to approval, according to Parexel or client guidelines/SOPs. Distribute final documents to project team and client. * Identify any potential project challenges to departmental line management and project leader, including changes in project plan, timeline or out of scope requests, and suggest possible resolution options. * Attend or lead proje