Senior Medical Writer/Principal Medical Writer

🔥 6 minutes ago

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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

• Leading the development of high-quality and on-time clinical study documents • Specific responsibilities include clinical document planning, writing, editing/formatting, and performing QC review • Develops documents in compliance with Precision MW Style Guide, Precision SOPs, applicable regulatory guidelines (ie, ICH, FDA, GCP) and eCTD requirements • Ensures smooth and effective document management from start to finish • Ability to independently formulate key messages from clinical study data • Ability to author complex content using knowledge/skills and understanding of processes • Contributes to the development and maintenance of medical writing processes, SOPs, templates, and work instructions for key documents • Performing literature-based research to support writing activities

🎯 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 (eg, ICH, FDA, GCP), clinical trial transparency requirements (ie, EudraCT, CT.gov), and 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

🏖️ Benefits

• This role is also eligible for a discretionary annual bonus • health insurance • retirement savings benefits • life insurance and disability benefits • parental leave • paid time off for sick leave and vacation