Lead Medical Writer, Global Regulatory Submissions

IQVIA Inc; Zaventem; On-site; EUR 90,000 - 130,000; Full time

Job summary

IQVIA Inc is seeking a Principal Medical Writer responsible for developing regulatory documents for submissions to authorities worldwide. You will guide cross-functional teams, oversee multiple compounds, and ensure high-quality, data-driven clinical messages across IBs, CSRs, and submission documents.

You will lead writing efforts, provide direction to other writers, and drive timely completion of high-quality documents aligned with regulatory standards.

Qualifications

• Proficiency in organizing and communicating clinical information with minimal oversight.
• Strong verbal, written, and interpersonal communication skills.

Responsibilities

• Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes.
• Manage medical writing projects, including developing timelines and cross-functional communication to maintain review cycles.
• Participate in cross-functional meetings to provide input on deliverables and timelines.
• Review documents such as Protocols and Statistical Analysis Plans as appropriate.
• Participate in process improvement initiatives and in defining SOPs for efficient document preparation.
• Manage internal and contract medical writing resources to ensure timely completion of projects.

Skills

Strong communication

Organizational skills

Time management

Project management

Education

Bachelor's degree

Advanced degree in scientific/clinical/regulatory field

Job description

IQVIA Inc is seeking a Principal Medical Writer responsible for developing regulatory documents for submissions to authorities worldwide. You will guide cross-functional teams, oversee multiple compounds, and ensure high-quality, data-driven clinical messages across IBs, CSRs, and submission documents.

You will lead writing efforts, provide direction to other writers, and drive timely completion of high-quality documents aligned with regulatory standards.