Precision Medicine Group - Senior Medical Writer
Upload My Resume
Drop here or click to browse · Tap to choose · PDF, DOCX, DOC, RTF, TXT
Requirements
• BS degree or equivalent in a scientific or medical discipline with relevant writing expertise • 5+ years of experience as a medical writer in the sponsor and/or CRO setting • 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 • Advanced degree (MS/PhD) • Oncology and/or rare disease experience (especially protocol and CSR development)
Responsibilities
• Essential functions of the job include but are not limited to: • 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 with a clear understanding of content requirements based on regulatory guidances • 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 • 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
Benefits
• Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
No credit card. Takes 10 seconds.