Senior Medical Writer: Regulatory Submissions Lead

IQVIA Inc; Paris; Vor Ort; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

IQVIA is seeking a Principal Medical Writer to lead the development of regulatory documents for submissions to regulatory authorities worldwide. You will provide strategic direction to cross-functional project teams and serve as lead writer for key summary documents, ensuring high-quality, data-driven messaging.

The role requires a Bachelor's degree (advanced degree preferred) and at least 5 years in medical writing within biopharmaceutical or CRO settings, with strong organizational and

Qualifikationen

• Bachelor's degree required; advanced degree preferred.
• At least 5 years of medical writing experience in biopharmaceutical/CRO.
• Ability to organize and communicate clinical information with minimal oversight.
• Strong time management and project management skills.

Aufgaben

• Develop regulatory documents for global submissions per ICH and client standards.
• Manage medical writing projects, including timelines and cross-functional communications.
• Participate in cross-functional meetings to align on deliverables and timelines.
• Review related documents (protocols, SAPs) for accuracy.
• Contribute to process improvements and SOPs for quality documents.
• Oversee internal and contract medical writing resources to meet deadlines.

Kenntnisse

Project management

Written communication

Verbal communication

Interpersonal skills

Ausbildung

Bachelor's degree

Advanced degree

Jobbeschreibung

IQVIA is seeking a Principal Medical Writer to lead the development of regulatory documents for submissions to regulatory authorities worldwide. You will provide strategic direction to cross-functional project teams and serve as lead writer for key summary documents, ensuring high-quality, data-driven messaging.

The role requires a Bachelor's degree (advanced degree preferred) and at least 5 years in medical writing within biopharmaceutical or CRO settings, with strong organizational and