Medical Writer II

Overview

In this role you lead the development of regulatory and clinical documents to support regulatory submissions and communicate scientific information effectively. You will guide writing, coordinate writers, and perform substantive editing to ensure high quality documents. You’ll shape strategies for complex submissions and collaborate with cross-functional teams to align content with regulatory requirements. This is a senior, expert writing role that drives standards and regulatory readiness across development programs. You will work in a mission-driven, collaborative environment that values integrity and inclusion, with a focus on delivering timely, compliant documentation.

Pay / Benefits

• Competitive base salary and performance-related incentives
• Health, dental, and vision coverage
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities

Responsibilities

• Coordinate and lead writing activities, review, and substantive editing of documents
• Prepare key regulatory response documents and documents supporting major submissions
• Formulate writing strategy, timelines, and assess resource requirements
• Lead writing strategy on organization, content, timelines, and resources
• Provide advanced input for study designs, analysis plans, IND sections, and marketing applications
• Review contributions and resolve issues to ensure consistency and compliance
• Manage deliverables for regulatory submissions within therapeutic areas
• Represent Medical Writing on cross-functional teams and as a regulatory strategy contact
• Serve as lead writer for important regulatory responses and components of submissions
• Provide leadership on teams addressing document preparation and production

Key requirements

• Bachelor’s degree in science or health profession
• 3+ years of experience writing for pharma or biotechnology (preferred)
• 3+ years of experience with electronic documents and submissions
• Experience with Clinical Study Reports, IBs, Protocols
• Understanding of clinical development processes and regulatory submissions (ICH guidelines, CTDs)
• Strong written and verbal communication skills and cross-functional collaboration abilities
• Problem-solving and interpersonal skills for team interactions

• Clear written and oral communication
• Cross-functional collaboration
• Problem-solving
• Electronic document management and submission workflows
• Knowledge of ICH guidelines and regulatory content requirements
• Experience with Clinical Study Reports, IBs, Protocols

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