Senior Medical Writer - Regulatory Submissions & Strategy

IQVIA; Brussel Hoofdstad; On-site; EUR 85,000 - 120,000; Full time

Job summary

IQVIA seeks a Principal Medical Writer to lead the development of regulatory documents for global submissions, including IBs, CSRs, and MA submissions. You will guide cross-functional teams to ensure messages are data-driven, scientifically rigorous, and accurately presented.

You will oversee multiple compounds, lead summary documents, and drive timely, high-quality deliverables while aligning with regulatory standards and program goals.

Qualifications

• Bachelor’s degree required. Advanced degree preferred.
• At least 5 years of medical writing experience in biopharmaceutical/CRO industry or comparable clinical/preclinical development experience.
• Proficiency in organizing and communicating clinical information with minimal oversight.
• Strong organizational, time management, and project management skills.
• Strong verbal, written, and interpersonal communication skills for teamwork.
• Knowledge of global regulatory requirements and therapeutic areas in all phases of clinical development.

Responsibilities

• Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines and client standards, adhering to study timelines and corporate objectives.
• Manage medical writing projects, including developing timelines and coordinating with cross-functional teams to monitor review cycles.
• Participate in cross-functional meetings to provide input on medical writing deliverables, timelines and processes.
• Review related project documents (eg, Protocols and Statistical Analysis Plans) as appropriate.
• Participate in cross-functional process improvement initiatives and in defining standard operating procedures for efficient document preparation.
• Manage internal and contract medical writing resources to ensure timely completion of projects.

Skills

Medical writing

Regulatory writing

Project management

Cross-functional collaboration

ICH guidelines

Education

Bachelor's degree in a scientific/clinical field

Job description

IQVIA seeks a Principal Medical Writer to lead the development of regulatory documents for global submissions, including IBs, CSRs, and MA submissions. You will guide cross-functional teams to ensure messages are data-driven, scientifically rigorous, and accurately presented.

You will oversee multiple compounds, lead summary documents, and drive timely, high-quality deliverables while aligning with regulatory standards and program goals.