Global Regulatory Medical Writer Lead

IQVIA Inc; Amsterdam; On-site; EUR 70,000 - 110,000; Full time

Job summary

IQVIA is seeking a Principal Medical Writer to lead the development of regulatory documents (IBs, CSRs, MA submissions) for global regulators. You will provide strategic direction to cross-functional teams, oversee multiple compounds, and ensure scientifically rigorous, well-presented data with accurate interpretation.

You will supervise writers, drive timelines, and contribute to SOPs and best practices, ensuring high-quality submissions while aligning with program goals and regulatory

Qualifications

• Bachelor's degree required. Advanced degree in a relevant scientific/clinical/regulatory field preferred.
• At least 5 years of medical writing experience in biopharmaceutical/CRO industry or equivalent.
• Proficiency in organizing and communicating clinical information with minimal oversight.
• Strong organizational, time management, and project management skills are required.
• Excellent verbal, written, and interpersonal communication skills for a team environment.
• Knowledge of global regulatory requirements and therapeutic areas in all phases of clinical development.

Responsibilities

• Develop regulatory documents for submission to global regulatory agencies per ICH and client standards.
• Manage medical writing projects, timelines, and cross-functional communications.
• Participate in cross-functional meetings to plan deliverables and timelines.
• Review protocols and statistical analysis plans as appropriate.
• Participate in process improvement initiatives and SOPs for efficient document preparation.
• Manage internal and contract medical writing resources to ensure timely delivery.

Skills

Strong organizational

Time management

Project management

Communication skills

Education

Bachelor's degree

Advanced degree in scientific/clinical/regulatory field

Job description

IQVIA is seeking a Principal Medical Writer to lead the development of regulatory documents (IBs, CSRs, MA submissions) for global regulators. You will provide strategic direction to cross-functional teams, oversee multiple compounds, and ensure scientifically rigorous, well-presented data with accurate interpretation.

You will supervise writers, drive timelines, and contribute to SOPs and best practices, ensuring high-quality submissions while aligning with program goals and regulatory