Senior Medical Writer (FSP) – Clinical document writing experience (Protocols, CSRs and IBs)

Overview

Senior Medical Writer (FSP) to lead and deliver clear, compliant medical writing for protocols, CSRs, IBs and related documents. You will coordinate across departments, mentor junior writers, and ensure high-quality deliverables within regulatory guidelines. The role sits within a collaborative Clinical Solutions team focused on accelerating drug development and patient progress. You’ll engage with clients, manage timelines, and contribute to process improvements in a fast-paced, therapeutic-focused environment. This is a key position for shaping scientific communications in oncology and other areas, with opportunities to influence broader client solutions and expand expertise.

Pay / Benefits

• company car or car allowance
• Health benefits (Medical, Dental, Vision)
• 401k with company match
• Employee Stock Purchase Plan
• commissions/bonus potential
• flexible paid time off (PTO) and sick time

Responsibilities

• Lead the completion of medical writing deliverables with clear, accurate scientific content
• Manage medical writing activities for studies across departments with minimal supervision
• Coordinate client comments resolution and drive timely responses
• Produce diverse documents (protocols, CSRs, IBs, safety reports, PD plans, NDA/eCTD submissions, manuscripts)
• Ensure compliance with ICH E3 and SOPs, templates, and style guides
• Coordinate quality and editorial reviews and manage source documentation
• Act as peer reviewer for internal teams to ensure content quality and formatting
• Review statistical analysis plans and output specifications for content and consistency
• Interact with clients and cross-functional teams to produce writing deliverables
• Mentor less experienced writers and contribute to internal materials and process improvements
• Develop topic expertise and understand regulatory guidelines affecting medical writing
• Monitor project budgets, hours, and communicate status to leadership
• Complete administrative tasks timely
• Occasional travel less than 25%
• May contribute to training and internal presentations

Key requirements

• medical writing experience in clinical document writing (protocols, CSRs, IBs)
• experience coordinating across departments
• familiarity with regulatory standards (ICH E3)
• ability to mentor others and lead reviews
• strong communication with clients and cross-functional teams
• budget awareness and time management
• attention to quality and consistency in documents

• collaboration
• problem solving
• mentoring/leadership
• clinical document writing
• ICH E3 compliance
• CSRs and IBs preparation

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