Global Regulatory Medical Writer – Lead Submissions

IQVIA Inc; Lisboa; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

IQVIA Inc seeks a Principal Medical Writer to develop regulatory documents for submissions to global regulatory authorities, including IBs, CSRs, and MA submissions. You will provide strategic direction to cross-functional teams and lead the writing of complex, data-driven clinical manuscripts to ensure accuracy and regulatory compliance.

You will oversee medical writing activities across multiple compounds, mentor other writers, and ensure timely delivery of high-quality documents in line with

Qualifications

• Bachelor's degree in a relevant field required; advanced degree preferred.
• At least 5 years of medical writing experience in biopharmaceutical/CRO industry or similar.
• Proficiency in organizing and communicating clinical information with minimal oversight.
• Strong organizational, time management and project management skills.
• Excellent verbal and written communication and interpersonal skills.

Responsabilités

• Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and client standards.
• Manage medical writing projects, including timelines and cross-functional communication.
• Participate in cross-functional meetings to provide input on deliverables and timelines.
• Review related documents (Protocol and Statistical Analysis Plans) as appropriate.
• Lead process improvements and define SOPs/best practices for efficient preparation of quality documents.
• Manage internal and contract medical writing resources to ensure timely completion.

Connaissances

Strong organizational skills

Time management

Project management

Verbal communication

Written communication

Interpersonal communication

Formation

Bachelor's degree

Advanced degree in a scientific/clinical/regulatory field

Description du poste

IQVIA Inc seeks a Principal Medical Writer to develop regulatory documents for submissions to global regulatory authorities, including IBs, CSRs, and MA submissions. You will provide strategic direction to cross-functional teams and lead the writing of complex, data-driven clinical manuscripts to ensure accuracy and regulatory compliance.

You will oversee medical writing activities across multiple compounds, mentor other writers, and ensure timely delivery of high-quality documents in line with