Principal Medical Writer

About the role

The Clinical and Regulatory Strategic Communications (CRSC) department within Global Clinical Trial Operations (GCTO) creates and delivers high-quality regulated content in support of our development pipeline and enables data sharing for our customers. We are a strategic partner that ensures excellence and compliance with applicable laws while incorporating health literacy principles in the development of public-facing materials.

Responsibilities

• Is recognized as a subject matter expert in the design, planning, authoring, editing, and review of accurate, clear, high-quality documents that reflect applicable medical writing best practices (e.g., lean writing, health literacy) and evolving regulatory requirements
• Is recognized as a strong scientific contributor and collaborator on cross-functional teams and demonstrates an understanding of team and project leadership responsibilities
• Applies critical thinking, problem solving, and negotiation skills to implement innovative solutions to complex challenges across the medical writing scope of work (e.g., documents, content, processes, timelines, tools) while navigating project team dynamics
• Provides program oversight by keeping project leads and/or management informed and escalates, as needed, issues that could impact timelines, quality, or compliance
• Demonstrates expertise in medical writing-specific tools and technology platforms
• Leads initiatives to improve medical writing processes and standards; may serve as a resource for this work internally and externally, as appropriate
• Applies in-depth knowledge of clinical development, relevant regulations, disease areas, and company products. Demonstrates a developing understanding of the pharmaceutical industry beyond clinical research
• Provides scientific and operational mentorship, coaching and/or project oversight to support other medical writers
• May manage direct reports including