Principal Medical Writer
The Execu|Search Group Warrenton, VA (Onsite) Full-Time
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Job Details
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A Connecticut-based pharmaceutical company is currently seeking a new Principal Medical Writer for a promising Remote opportunity with their growing staff. In this role, the Principal Medical Writer (Remote) will be responsible for development and management of medical writing deliverables that support the clinical regulatory writing portfolio and is capable of working independently to achieve goals.Responsibilities The Principal Medical Writer will:Provide functional and team guidance for medical writing processes and standardsCoordinate and author regulatory documents by ensure the coordination and integration of scientific, medical, and regulatory input from development team membersServe as writer for various assets, including strategizing and managing projects, to complete multiple documents for regulatory submissions and clinical deliverablesProvide support for Medical Writing team and accountability for high quality deliverablesParticipate in relevant filing subteams and ensure effective planning and management of timelines for all components of assigned documentsProduce high-quality and timely documentation in line with expectationsProvide input on data analysis planning and interpretationCoordinate quality control review of documentsPerform other duties, as neededQualifications 3+ years of Medical Writing experience with a focus in Oncology, Neuroscience, and/or Rare Diseases3+ years of experience in the Biotechnology, Pharmaceutical, Medical, and/or Research industryBachelor's DegreeGood understanding of Global Pharmaceutical Drug Development and requirements for submission of regulatory dossiers to global health authoritiesFamiliarity with SharePoint and concepts of Structured Content ManagementMicrosoft Office Suite proficientSolid problem solving and time management skillsGreat interpersonal skillsExcellent communication skills (written and verbal)Strong attention to detailHighly organized
Recommended Skills
• Biotechnology
• Clinical Works
• Communication
• Data Analysis
• Drug Development
• Filing
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Job ID: e8e5ffeccaf5fdea554ba3d86c894f56
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