Senior Medical Writer/Principal Medical Writer
New
P
Precision for MedicineClinical Research
Remote, United StatesFull-TimeSenior
Salary$100,600 — $182,600 USD
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Job Details
- Experience
- 5+ years
- Required Skills
- GCPMicrosoft Office
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 (e.g., ICH, FDA, GCP).
- Knowledge of clinical trial transparency requirements (e.g., EudraCT, CT.gov) and eCTD requirements.
- Impeccable attention to detail and ability to complete assignments in a timely manner.
- Ability to work effectively in a fast-paced environment with multiple high-priority projects.
- Advanced degree (MS/PhD) preferred.
- Oncology and/or rare disease experience preferred.
Responsibilities
- Plan, write, edit, format, and perform QC review of clinical documents including protocols, IBs, ICF templates, DSURs, CSRs, and patient narratives.
- Manage document lifecycle from template to final approval in collaboration with internal and external stakeholders.
- Independently formulate key messages from clinical study data.
- Communicate complex clinical content clearly and concisely to internal and client teams.
- Contribute to the development and maintenance of medical writing processes, SOPs, and templates.
- Perform literature-based research to support clinical writing activities.
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