Principal Medical Writer: Regulatory Strategy & Submissions

IQVIA; Paris; Vor Ort; EUR 75.000 - 110.000; Vollzeit

Zusammenfassung

IQVIA is seeking a Principal Medical Writer in Paris to develop regulatory documents (IBs, CSRs, submission documents) for global regulatory authorities. You will lead and guide other writers, ensuring rigorous, data-accurate narratives across multiple compounds.

Strong organizational and communication skills are essential for coordinating cross-functional teams and meeting timelines. The role requires a Bachelor's degree (advanced degree preferred) and at least 5 years in medical writing within

Qualifikationen

• Bachelor's degree required; advanced degree preferred.
• At least 5 years of medical writing in biopharma/CRO or equivalent.
• Ability to organize and communicate clinical information with minimal oversight.
• Strong organizational, time management, and project management skills.
• Excellent verbal, written, and interpersonal communication for team work.
• Knowledge of global regulatory requirements and therapeutic areas.

Aufgaben

• Develop regulatory documents for global regulatory submissions in line with ICH and client standards.
• Manage medical writing projects with timelines and cross-functional communication.
• Participate in cross-functional meetings to guide deliverables and timelines.
• Review protocols and statistical analysis plans as appropriate.
• Contribute to process improvement and SOP/best-practice development.
• Oversee internal and contract medical writing resources to ensure timely completion.

Kenntnisse

Regulatory writing

Project management

Cross-functional teamwork

Communication skills

Time management

Ausbildung

Bachelor's degree

Advanced degree preferred

Jobbeschreibung

IQVIA is seeking a Principal Medical Writer in Paris to develop regulatory documents (IBs, CSRs, submission documents) for global regulatory authorities. You will lead and guide other writers, ensuring rigorous, data-accurate narratives across multiple compounds.

Strong organizational and communication skills are essential for coordinating cross-functional teams and meeting timelines. The role requires a Bachelor's degree (advanced degree preferred) and at least 5 years in medical writing within