Senior Medical Writer / Principal Medical Writer
New
P
Precision Medicine GroupClinical Research
Remote, United StatesFull-TimeSenior
Salary$100,600 — $182,600 USD
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Job Details
- Experience
- 5+ years
- Required Skills
- GCPMicrosoft Excel
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.
- 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 study protocols, IBs, ICF templates, DSURs, CSRs, and patient narratives.
- Manage documentation from template to final version in collaboration with sponsors, vendors, and internal teams.
- Formulate key messages independently from clinical study data.
- Author complex content based on established processes and regulatory requirements.
- Communicate clearly and concisely with internal and client teams.
- Contribute to the maintenance of SOPs, templates, and work instructions.
- Perform literature-based research to support writing activities.
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