Job Description
The Clinical and Regulatory Strategic Communications (CRSC) department within General 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.
The Principal Medical Writer, in partnership with a project lead, leverages strategic and scientific expertise to develop, author, edit, and lead the review of accurate, clear, and compliant clinical, regulatory, and/or public‑facing documents, across multiple programs and therapeutic areas, in support of the company portfolio.
In this role, the Principal Medical Writer:
- 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
📌 Principal Medical Writer (Guaduas)
🏢 Msd
📍 Guaduas