![]() ![]() Follows directions, templates, and structured processes for delivering documents for review and.Expert level authoring in MS Word, understanding of MS Word functionality, and works with WordĪdd-ins that facilitate the management of fonts, styles, references, etc. ![]() Focused writing and editing following defined processes and templates.Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements.Completes timesheets accurately as required.Complies with required training curriculum.Conducts appropriate literature searches, as needed.Works as an active member of cross-functional teams representing Medical Writing.Ensures adherence to standard content, lean authoring, and messaging across team members.Applies lean authoring principles as part of document development and, when applicable, structured content management (SCM) text libraries as part of authoring process.Manages messaging for consistency with historical information and in alignment with agreed-upon strategy.With minimal guidance from senior members of writing staff, prepares clinical study reports (CSRs), protocols, investigator brochures (IBs), submission data summaries, and other regulatory documents on investigational drugs in various stages of clinical development.Develops and maintains timelines in project plans, using project tracking application following standard templates.Develops, coordinates, and oversees work plans for both individual and multiple-document delivery, with all the needed tasks and subtasks, timelines, and assigned roles and responsibilities that enable the team to work efficiently and effectively to deliver all milestone tasks and documents within specified timelines.Possible participation in the orientation and coaching of junior team members.Ensures communication between members remains open and information is disseminated appropriately.Coordinates activities for document review, consensus meeting, quality control, and document finalization under aggressive timelines.Coordinates and delivers document kick-off meetings with contributors or representatives from cross-functional groups.Leads cross-functional teams to draft agreed-upon scientific/medical content that addresses data interpretation, product claims, and internal/external questions.The Senior Medical Writer is responsible for the development of medical writing deliverables that support the clinical regulatory writing portfolio and works with guidance and oversight to achieve goals. Parexel is looking for a Senior Medical Writer! This is a remote position and can be based anywhere in the United States and Canada.Įarly Stage Development, Phase 1/PK Medical Writing experience highly preferred ![]()
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