About this role TFS HealthScience is a leading global, mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and functional service (FSP) solutions.
The Senior Medical Writer is part of the Medical Writing Department within Project Delivery and will work independently on preparing and completing clinical and regulatory documentation in assigned Study Teams, according to company policies, SOPs and regulatory requirements. The Senior Medical Writer has a broad and long experience of all matters within medical writing.
Key Responsibilities Write and review synopsis and Clinical Study Reports/Clinical Investigation ReportsPrepare protocols, monographs, patient narratives, and manuscripts for journal publicationsReview of Statistical Analysis PlansCo-ordinate the TFS Report Writing TeamWrite and review Clinical Study Protocols/Clinical Investigation Plans and Subject InformationWrite and review Investigator's Brochures/Clinical Investigator's BrochuresWrite and review Investigational Medicinal Product DossiersWrite and review clinical summaries and overviewsWrite and review publicationsTranslate/correct clinical and regulatory documentsActively contribute to the organization and development of routines to enhance the work at TFSWrite and review abstracts/postersLiterature reviewParticipate in client meetings regarding project-related issuesCoach and support Medical WritersAdvise clients and other Units in methodological and scientific aspects of studiesContact with Key Opinion Leaders and Medical Experts working as external consultantsQualifications: Bachelor's Degree or relevant experience4-5 years of relevant experienceKnowledge of medical terminologyExcellent writing, editing and organizational skillsExcellent verbal and communication skillsProficiency in word processing software What We Offer We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You'll be joining a team that values collaboration, innovation, and making a difference in the lives of patients.
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