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Senior Medical Writer
Precision For MedicineSenior Medical Writer leading high-quality clinical document development at Precision for Medicine. Responsible for writing, editing, and ensuring compliance with regulatory guidelines.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- leading the development of high-quality and on-time clinical study documents
- 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 (ie, from template to final, approved version)
- ability to independently formulate key messages from clinical study data
- 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
What you’ll need- 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
Benefits
Comp & perks- health insurance
- retirement savings benefits
- life insurance
- disability benefits
- parental leave
- paid time off for sick leave and vacation
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical document writingeditingformattingQC reviewliterature-based researchmedical writing processesSOPs developmenttemplate creationregulatory complianceeCTD requirements
Soft Skills
attention to detailtimelinessindependent formulation of key messagesability to work in fast-paced environmenthandling multiple high priority projects