Senior Medical Writer/Principal Medical Writer

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Precision For Medicine

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $75M Private Equity Round on 2015-12

Biotechnology • Healthcare Insurance • Pharmaceuticals

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. • Planning, writing, editing, formatting, and QC review of timely and high-quality clinical documents including clinical study protocols, IBs, ICF templates, DSURs, CSRs, CSR patient narratives. • Ensures smooth and effective document management from start to finish in collaboration with Sponsor, external vendors, and/or internal Precision project teams/departments. • Ability to independently formulate key messages from clinical study data. • Ability to author complex content using knowledge/skills and understanding of processes. • Ability to communicate clearly and concisely both in writing and verbally with internal and client teams. • Contributes to the development and maintenance of medical writing processes, SOPs, templates, and work instructions for key documents. • Excellent problem-solving skills. • 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

• Privacy Policy. • California applicants privacy notice.