Job Title: Principal Medical Writer, Oncology
Company: ProPharma
Location: United States
Job Type: Full-Time
Experience Required: 7+ Years
Qualification: Bachelor’s / Master’s in Medical or Scientific Discipline
Job Overview
Principal Medical Writer specializing in Oncology responsible for leading end-to-end clinical and regulatory medical writing deliverables across global drug development programs. The role includes authorship of complex regulatory documents, cross-functional coordination, client communication, and mentorship of junior writers.
Key Responsibilities
Medical Writing & Regulatory Documentation
Independently author clinical and regulatory documents including:
Protocols & amendments
Clinical Study Reports (CSR)
Investigator’s Brochures (IB)
Informed Consent Forms (ICF)
Patient narratives
DSUR, PBRER, IND, NDA, BLA, MAA documents
eCTD submission-ready documentation
Ensure scientific accuracy, consistency, and regulatory compliance
Cross-Functional Coordination
Collaborate with clinical operations, biostatistics, data management, and regulatory affairs teams
Coordinate with SMEs to ensure completeness and accuracy of documents
Manage cross-functional document review cycles and timelines
Quality Control & Compliance
Perform QC reviews of statistical outputs, tables, figures, and listings
Ensure compliance with ICH guidelines (E3, E6), FDA, EMA, and client SOPs
Maintain audit trails and version control for all documents
Project & Client Management
Manage multiple writing projects simultaneously
Communicate directly with clients and manage expectations
Lead project meetings (kickoff, review, status updates)
Track timelines, deliverables, and budgets
Leadership & Mentoring
Train and mentor junior medical writers
Perform peer reviews of documents
Lead process improvement initiatives and internal knowledge-sharing programs
Strategic & Operational Support
Review SAPs and statistical outputs for consistency
Identify risks, gaps, and inefficiencies in documentation processes
Recommend process improvements to leadership
Required Skills
Clinical & Regulatory Medical Writing (Expert Level)
Oncology Drug Development Knowledge
Regulatory Submissions (IND, NDA, BLA, MAA)
ICH Guidelines (E3, E6)
FDA / EMA Regulatory Standards
Scientific Writing & Data Interpretation
CSR & Clinical Protocol Writing
Strong Project Management Skills
Cross-functional Collaboration
AMA Style Writing
Quality Control & Document Review
Stakeholder & Client Management
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