Principal Medical Writer

Overview

In this role, you define and drive the medical writing strategy for one or more clinical programs, ensuring high-quality, strategically aligned deliverables. You will shape the messaging across a program and contribute to clinical development and submission plans, interacting with regulatory authorities globally. You operate within cross-functional, international teams to deliver clear, accurate communications that support regulatory requirements and scientific insight. This is a leadership role with broad program impact and collaboration with global stakeholders.

Responsibilities

• Lead medical writing contributions to assigned clinical programs
• Develop and drive the messaging strategy for the program
• Ensure deliverable quality and adherence to procedures and standards
• Provide strategic input into development and submission plans
• Analyze plans, studies, and documents for audience-focused communication with regulatory authorities
• Collaborate with global teams and regulatory agencies across regions

Key requirements

• Bachelor in science-related discipline with 5+ years medical writing in biopharma or CRO
• Post-graduate qualifications desired (PhD or MD preferred)
• Comprehensive understanding of medical writing for clinical development and regulatory requirements
• Experience with CTD submissions
• Proven ability to work independently or in teams and influence without formal authority
• Excellent written, verbal, and presentation skills
• Mastery of English language, grammar, and punctuation
• Strong organizational and time management skills
• Experience in ICH-GCP and complex regulatory writing projects

• cross-functional collaboration
• intercultural communication
• influencing and leadership without authority
• CTD format submissions
• MS Office (word, tables, presentations, graphics)
• English language proficiency (grammar, punctuation)

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