Principal Medical Writer – FSP

Overview

In this role you act as Lead Medical Writer and drive the preparation of core documents to high quality standards and client requirements. You will manage timelines, coordinate reviews, and negotiate with customers while mentoring junior staff. You stay current with regulatory and scientific writing developments to support drug development programs. You will contribute to cross-functional efforts and may take on project management responsibilities for complex writing projects, including budgeting and invoicing. This is a client-facing, impact-focused role within IQVIA’s medical writing function.

Responsibilities

• Lead the creation of assigned documents (CSRs, protocols, etc.), confirm scope, templates, and timelines, and communicate with customers
• Plan and manage workload, track timelines, and implement customer requests
• Lead meetings on challenging topics and present Medical Writing processes when appropriate
• Train and mentor junior staff; deliver knowledge-sharing to global teams
• Possibly act as Project Manager for complex writing projects, including project finance and budgeting
• Monitor budgets, forecast hours, and approve costings for routine projects
• Represent Medical Writing in regional or cross-functional initiatives
• Identify and brainstorm new ideas to improve processes and quality
• Support capability audits and maintain strong stakeholder relationships
• Proactively assess risks and communicate solutions to colleagues and customers

Key requirements

• 5+ years of highly relevant Medical Writing experience
• In-depth knowledge of structure and content requirements of CSRs, protocols, and related documents
• Strong understanding of statistical methods in clinical trials and ability to review SAPs
• Ability to synthesize data from multiple sources clearly and concisely
• Proven track record as a lead writer for CSRs and protocols with positive feedback
• Deep knowledge of drug development, medical writing, and regulatory expectations
• Excellent written and verbal communication, precise grammar and technical writing
• Attention to detail, strong negotiation skills, and ability to deliver difficult messages constructively
• Initiative, sound judgment, and ability to work independently and collaboratively
• Ability to manage multiple tasks and projects and establish effective working relationships
• Risk assessment and issue resolution skills; computer literacy

• excellent communication
• negotiation
• collaboration
• clinical study reports (CSRs) writing
• protocols
• statistical methods and interpretation

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