Principal Medical Writer leading CMC regulatory submissions for Veristat’s life - sciences clients. Authoring Modules 3 and 2.3 while guiding project teams and mentoring regulatory writers.
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Senior Medical Writer/Principal Medical Writer
Posted 2 months ago
About the role
- Senior Medical Writer developing clinical study documents at Precision for Medicine. Leading document management, clinical document planning, and ensuring regulatory compliance.
Responsibilities
- 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
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