Senior Medical Writer & Regulatory Strategy Lead

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

Job summary

IQVIA is seeking a Principal Medical Writer to lead the development of regulatory documents for global submissions, providing strategic direction to cross-functional teams and ensuring accurate data presentation in line with program goals and regulatory requirements. Based in Ireland, you will shape clinical messaging across IBs, CSRs and submission documents.

The role oversees multiple compounds, mentors other writers, and drives process improvements to align with ICH guidelines and global

Qualifications

• Bachelor's degree required; advanced degree 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.
• Strong verbal, written, and interpersonal communication.
• Knowledge of global regulatory requirements across clinical development.

Responsibilities

• Develop regulatory documents for global submissions per ICH/global guidelines and client standards.
• Manage medical writing projects, develop timelines, and coordinate with cross-functional teams.
• Participate in cross-functional meetings to align deliverables and timelines.
• Review related project documents (protocols, SAPs) as appropriate.
• Participate in process improvements and SOPs for quality document prep.
• Lead management of internal/contract medical writing resources to ensure timely completion.

Skills

Organizational skills

Communication skills

Project management

Team collaboration

Regulatory knowledge

Education

Bachelor's degree

Advanced degree preferred

Job description

IQVIA is seeking a Principal Medical Writer to lead the development of regulatory documents for global submissions, providing strategic direction to cross-functional teams and ensuring accurate data presentation in line with program goals and regulatory requirements. Based in Ireland, you will shape clinical messaging across IBs, CSRs and submission documents.

The role oversees multiple compounds, mentors other writers, and drives process improvements to align with ICH guidelines and global