Senior Medical Writer – Regulatory Submissions Lead

IQVIA Inc; Paris; Sur place; EUR 70 000 - 100 000; Plein temps

Résumé du poste

IQVIA is seeking a Principal Medical Writer to lead global regulatory documents (IBs, CSRs, and submission materials) with minimal oversight, ensuring rigorous data presentation and regulatory compliance. You will guide cross-functional teams to deliver high-quality clinical documents on schedule.

As lead writer for multiple compounds, you will oversee writing activities, mentor junior writers, and shape strategic direction across therapeutic areas to optimize regulatory submissions.

Qualifications

• Expertise in preparing regulatory documents (IBs, CSRs, submission dossiers).
• Ability to coordinate cross-functional teams and timelines.
• Strong data interpretation and scientific writing skills.
• Excellent communication and interpersonal abilities.
• Proven track record in GMP/GLP environments and regulatory standards.

Responsabilités

• Develop regulatory documents for global regulatory submissions.
• Manage medical writing projects and timelines with cross-functional teams.
• Lead writing efforts for multiple compounds and act as senior writer.
• Review study documents and contribute to SOPs and best practices.
• Oversee internal and contract medical writing resources.

Connaissances

Regulatory writing

Project management

ICH guidelines

Team leadership

Formation

Bachelor's degree in life sciences

Advanced degree preferred

Description du poste

IQVIA is seeking a Principal Medical Writer to lead global regulatory documents (IBs, CSRs, and submission materials) with minimal oversight, ensuring rigorous data presentation and regulatory compliance. You will guide cross-functional teams to deliver high-quality clinical documents on schedule.

As lead writer for multiple compounds, you will oversee writing activities, mentor junior writers, and shape strategic direction across therapeutic areas to optimize regulatory submissions.