Senior Medical Writer/Principal Medical Writer

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Precision Medicine Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2012

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $35.2M Venture Round on 2021-03

Biotechnology • Healthcare Insurance • Pharmaceuticals

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

• Leading the development of high-quality and on-time clinical study documents • Clinical document planning, writing, editing/formatting, and performing QC review • Develop 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 (ie, from template to final, approved version) 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 • 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

• Any data provided as a part of this application will be stored in accordance with our Privacy Policy. • Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. • For CA applicants, please also refer to our CA Privacy Notice.