Global Regulatory Medical Writer Lead

IQVIA Inc; Dublin; Presencial; EUR 90.000 - 130.000; Jornada completa

Descripción de la vacante

IQVIA Inc is seeking a Principal Medical Writer in Dublin, Ireland, responsible for developing regulatory documents for submissions to regulatory authorities worldwide. You will provide strategic direction to cross-functional teams to ensure data-driven messages are accurate and compliant with ICH and global guidelines.

Lead the writing of final submission documents and oversee multiple compounds, mentoring other writers to deliver high-quality, timely documents with rigorous scientific

Formación

• Bachelor's degree required; advanced degree preferred.
• 5+ years of medical writing experience in biopharmaceutical/CRO.
• Proficiency in organizing and communicating clinical information with minimal oversight.
• Strong organizational and project management skills.
• Knowledge of global regulatory requirements and therapeutic areas.

Responsabilidades

• Develop regulatory documents for submissions to regulatory agencies globally.
• Manage medical writing projects, including timelines and cross-functional communication.
• Participate in cross-functional meetings to provide input on deliverables and timelines.
• Review documents such as Protocols and Statistical Analysis Plans.
• Participate in process improvement initiatives and SOPs for quality documents.
• Manage internal and contract medical writing resources to ensure timely completion.

Conocimientos

Regulatory writing

Project management

Clinical data communication

Team collaboration

Educación

Bachelor's degree

Advanced degree (scientific/clinical/regulatory)

Descripción del empleo

IQVIA Inc is seeking a Principal Medical Writer in Dublin, Ireland, responsible for developing regulatory documents for submissions to regulatory authorities worldwide. You will provide strategic direction to cross-functional teams to ensure data-driven messages are accurate and compliant with ICH and global guidelines.

Lead the writing of final submission documents and oversee multiple compounds, mentoring other writers to deliver high-quality, timely documents with rigorous scientific