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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 quality control review of clinical documents including protocols, investigator's brochures (IBs), informed consent forms (ICF), development safety update reports (DSURs), clinical study reports (CSRs), and patient narratives.
Key responsibilities include:
- Planning, writing, editing, formatting, and QC review of clinical documents with clear understanding of regulatory content requirements
- Ensuring smooth document management from template through final approved version, collaborating with sponsors, external vendors, and internal teams
- Independently formulating key messages from clinical study data
- Authoring complex content using advanced knowledge and understanding 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
- Developing documents in compliance with company style guides, SOPs, ICH guidelines, FDA requirements, GCP standards, and eCTD requirements
The successful candidate will demonstrate impeccable attention to detail, ability to work independently on routine assignments with minimal guidance on new projects, and effectiveness in fast-paced environments managing multiple high-priority projects simultaneously.
QUALIFICATIONS:
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 settings, 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 (ICH, FDA, GCP), clinical trial transparency requirements (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 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
