Senior Medical Writer/Principal Medical Writer

Position Summary

The Senior Medical Writer/Principal Medical Writer will lead the development of high-quality and on-time clinical study documents. Specific responsibilities include clinical document planning, writing, editing/formatting, and performing QC review. Duties must comply with Precision MW Style Guide, Precision SOPs, applicable regulatory guidelines (ICH, FDA, GCP), and eCTD requirements.

Essential Functions

• Planning, writing, editing, formatting, and QC review of timely and high-quality clinical documents including clinical study protocols, IBs, ICF templates, DSURs, CSRs, CSR patient narratives with a clear understanding of content requirements based on regulatory guidances
• Ensures smooth and effective document management from start to finish (from template to final, approved version) in collaboration with Sponsor, external vendors, and/or internal Precision project teams/departments
• Ability to independently formulate key messages from clinical study data
• Ability to author complex content using knowledge/skills and understanding of processes
• Ability to communicate clearly and concisely both in writing and verbally with internal and client teams
• Contributes to the development and maintenance of medical writing processes, SOPs, templates, and work instructions for key documents
• Excellent problem-solving skills
• Performing literature-based research to support writing activities
• Other duties as assigned

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 the sponsor and/or CRO setting or 7+ years of experience as a Principal Medical Writer
• Other Required:
• - 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 a fast-paced environment with multiple high priority projects with no instruction on routine work and minimal instruction on new assignments
• Preferred:
• - Advanced degree (MS/PhD)
• - Oncology and/or rare disease experience (especially protocol and CSR development)

Reasonable Estimate of the Current Range

$100,600 - $182,600 USD

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Equal Opportunity Employer

Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

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