Principal Medical Writer

Principal Medical Writer

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.

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 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 workload, professional development, and performance management

Qualifications

• Required: Bachelor's degree or higher preferably in a health, scientific, or relevant discipline (e.g., life sciences, pharmacy, medicine, public health)
• 5+ years of relevant medical writing or industry experience

Required skills & experience

• Experience managing complex writing projects in a deadline-driven environment and leading teams of medical writers and/or cross-functional team members
• Ability to critically evaluate and interpret clinical data clearly, objectively, and in accordance with regulatory requirements and industry guidelines
• Demonstrated critical thinking and problem-solving capabilities, with an ability to innovate, influence, and drive change
• Demonstrated effective leadership across organizational levels, including conflict resolution, negotiation, navigating teams through ambiguity, and decision making
• Excellent oral and written communication and presentation skills
• Technical expertise in commonly used office applications (e.g., Microsoft Office Suite) shared document systems (e.g., SharePoint) and willingness to learn and adapt to emerging technology

Required Skills:

Adaptability, Clinical Studies, Clinical Trials Operations, Data Analysis, Good Clinical Practice (GCP), Health Literacy, Medical Writing, Project Management, Regulatory Compliance, Stakeholder Alignment, Standard Operating Procedure (SOP), Strategic Thinking

Preferred Skills:

Clinical Trials, Leadership, Regulatory Submissions, Technical Knowledge