Senior Medical Writer/Principal Medical Writer

🔥 1 minute ago

🇷🇴 Romania – Remote

💵 $100.6k - $182.6k / year

⏰ Full Time

🟠 Senior

🏥📝 Medical Writer

👻 Ghost score 0%

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Precision For Medicine

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 $75M Private Equity Round on 2015-12

Healthcare • Consulting • Logistics

Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.

📋 Description

• Lead development of high-quality, on-time clinical study documents • Plan, write, edit, format, and perform QC review of clinical documents, including clinical study protocols, IBs, ICF templates, DSURs, CSRs, and CSR patient narratives • Develop documents in compliance with Precision MW Style Guide, Precision SOPs, ICH, FDA, GCP, and eCTD requirements • Manage documents from template through final approved version in collaboration with sponsors, external vendors, and internal Precision project teams/departments • Independently formulate key messages from clinical study data • Author complex content using knowledge of relevant processes • Communicate clearly and concisely with internal and client teams • Contribute to medical writing processes, SOPs, templates, and work instructions • Perform literature-based research to support writing activities • Perform other duties as assigned

🎯 Requirements

• BS degree or equivalent in a scientific or medical discipline with relevant writing expertise • 5+ years of experience as a Sr. Medical Writer in the sponsor and/or CRO setting, or 7+ years of experience as a Principal Medical Writer • Proficiency with Microsoft Windows, Teams, Word, Excel, Adobe Acrobat, and PowerPoint • Clear understanding of applicable regulations, including ICH, FDA, and GCP • Understanding of clinical trial transparency requirements, including EudraCT and CT.gov • Understanding of eCTD requirements for all phases of development • Impeccable attention to detail and ability to complete writing assignments in a timely manner • Ability to work effectively in a fast-paced environment with multiple high-priority projects • Advanced degree (MS/PhD) preferred • Oncology and/or rare disease experience preferred