Project management of contractual and financial aspects may only be performed with the guidance of medical writing 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. This includes both copyediting and content review. Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. Ensure that all work is complete and of high quality prior to team distribution or shipment to client. Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input. Update/aggregate reports, and integrated summaries of safety and efficacy. 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 Responsibilities will also include: acting as the primary client contact for medical writing projects, working with other Parexel departments and clients to set and meet internal/external deliverable timelines, project leadership, and training and support of junior medical writing staff. These roles can be fully home based in various European countries such as Belgium, Croatia, Czech Republic, Denmark, France, Finland, Germany, Georgia, Hungary, Ireland, Italy, Lithuania, Poland, Romania, Russia, Serbia, Spain, Sweden, Ukraine, or the UK.Īs the Senior Medical Writer - FSP, you will be aligned to a single client, you will research, create, and edit all documents associated with clinical research. We are looking for a number of Senior Medical Writer's - FSP due to an ever expanding team. We believe in our values Patients First, Quality, Respect, Empowerment & Accountability. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. Parexel is in the business of improving the world’s health.
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