Principal Medical Writer – Publications

Overview

Principal Medical Writer in publications leads the delivery of complex, high-quality medical writing for regulatory and scientific documents. You work within the Clinical Solutions team to shape writing strategy, ensure regulatory and quality standards, and collaborate with clients and cross-functional teams. You drive clear, accurate storytelling of clinical data and act as a technical SME to advance company priorities. This role offers impact in shaping pivotal documents and mentoring peers within a dynamic, patient-focused environment.

Pay / Benefits

• career development
• total rewards program
• inclusive culture
• peer recognition
• data-driven performance
• cross-functional exposure

Responsibilities

• Lead and coordinate medical writing activities across departments for complex studies
• Create and manage document strategy for clinical study protocols, reports, submissions, and manuscripts
• Ensure regulatory compliance (ICH E3) and adherence to SOPs, templates, and styles
• Advise on data presentation and production strategies to meet client objectives
• Oversee document reviews, quality control, and editorial reviews; manage source documentation
• Mentor and develop less-experienced writers; serve as a technical SME
• Review statistical analysis plans and output specifications for quality and consistency
• Maintain client relationships and communicate status, timelines, and changes to leadership
• Support budgeting, bid projections, and project planning for writing deliverables
• Represent the writing department in study teams, conferences, and client meetings
• Complete administrative tasks on time and perform additional duties as assigned
• Occasionally travel up to <25%

Key requirements

• extensive medical writing experience for regulatory and scientific documents
• ability to lead, mentor, and manage writing projects across teams
• familiarity with regulatory standards and industry guidelines (ICH E3)
• strong client-facing communication and cross-functional collaboration
• budget awareness and project planning abilities
• ability to review and guide statistical outputs and tables/figures/listings

• leadership and mentorship
• clear communication
• collaboration across functions
• medical writing for regulatory documents (protocols, CSRs, IBs, NDA/eCTD submissions)
• journal manuscripts, abstracts, posters
• editorial and quality reviews; style and formatting guides

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