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Precision Medicine Group seeks a Senior Medical Writer or Principal Medical Writer to lead the development of high-quality, timely clinical study documents. This role is responsible for planning, writing, editing, formatting, and QC review of clinical documents including protocols, Investigator's Brochures (IBs), Informed Consent Forms (ICF), DSURs, Clinical Study Reports (CSRs), and patient narratives. The successful candidate will ensure smooth document management from template through final approval, collaborating with sponsors, external vendors, and internal teams.
Key responsibilities include:
- Planning, writing, editing, formatting, and QC review of clinical documents with clear understanding of regulatory content requirements
- Managing document workflows from start to finish in collaboration with sponsors and project teams
- Independently formulating key messages from clinical study data
- Authoring complex content using advanced knowledge of regulatory processes
- Clear written and verbal communication with internal and client teams
- Contributing to development and maintenance of medical writing processes, SOPs, templates, and work instructions
- Problem-solving and literature-based research to support writing activities
The role requires expertise in regulatory compliance (ICH, FDA, GCP), clinical trial transparency requirements (EudraCT, CT.gov), and eCTD requirements across all development phases. The candidate will work in a fast-paced environment managing multiple high-priority projects with minimal instruction on routine work.
REQUIREMENTS:
Minimum Required:
- BS degree or equivalent in a scientific or medical discipline with relevant writing expertise
- 5+ years of experience as a Senior Medical Writer in sponsor and/or CRO setting, OR 7+ years as a Principal Medical Writer
- Proficiency with Microsoft Windows, Teams, Word, Excel, Adobe Acrobat, and PowerPoint
- Clear understanding of applicable regulations (ICH, FDA, GCP), clinical trial transparency requirements, 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 fast-paced environment with multiple high-priority projects with minimal instruction
Preferred:
- Advanced degree (MS/PhD)
- Oncology and/or rare disease experience, especially in protocol and CSR development
