Senior Medical Writer, Global Regulatory Submissions

IQVIA Inc; Greater London; Presencial; GBP 60.000 - 100.000; Jornada completa

Descripción de la vacante

IQVIA Inc. is seeking a Principal Medical Writer to lead the development of regulatory documents for global submissions. You will provide strategic direction to cross-functional teams and oversee multiple compounds, ensuring scientifically rigorous and accurately presented data.

The role requires a strong background in medical writing, regulatory standards, and project management, with experience guiding junior writers and coordinating timelines across global projects.

Formación

• Bachelor's degree required with advanced degree preferred.
• Minimum 5 years in medical writing within biopharmaceuticals or CRO.
• Strong ability to present data-driven clinical messages clearly.

Responsabilidades

• Develop regulatory documents (IBs, CSRs, submissions) for global regulatory authorities.
• Lead medical writing projects and manage timelines with cross-functional teams.
• Provide input in cross-functional meetings on deliverables and schedules.
• Review study documents (Protocols, SAPs) and ensure quality data presentation.
• Drive process improvements and write SOPs for efficient document prep.
• Oversee internal and vendor medical writing resources to meet deadlines.

Conocimientos

Medical writing

Regulatory documents

Project management

Communication

Educación

Bachelor's degree

Advanced degree preferred

Descripción del empleo

IQVIA Inc. is seeking a Principal Medical Writer to lead the development of regulatory documents for global submissions. You will provide strategic direction to cross-functional teams and oversee multiple compounds, ensuring scientifically rigorous and accurately presented data.

The role requires a strong background in medical writing, regulatory standards, and project management, with experience guiding junior writers and coordinating timelines across global projects.