Senior Medical Writer / Principal Medical Writer

🔥 1 minute ago

🇷🇴 Romania – Remote

💵 $100.6k - $182.6k / year

⏰ Full Time

🟠 Senior

🏥📝 Medical Writer

👻 Ghost score 11%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Precision Medicine Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2012

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 $35.2M Venture Round on 2021-03

Consulting • Healthcare • Logistics

Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.

📋 Description

• Lead the development of high-quality and 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, applicable regulatory guidelines, and eCTD requirements • Ensure smooth and effective document management 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, skills, and understanding of processes • Communicate clearly and concisely in writing and verbally with internal and client teams • Contribute to the development and maintenance of 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 • Knowledge 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, with no instruction on routine work and minimal instruction on new assignments