Strategic Medical Writing Lead for Regulatory Submissions

IQVIA; Greater London; Presencial; GBP 80.000 - 110.000; Tempo integral

Resumo da vaga

IQVIA is seeking a Principal Medical Writer to lead the development of regulatory documents for global submissions, providing strategic direction to cross-functional teams. You will oversee multiple compounds and serve as lead writer for final summaries, ensuring scientifically rigorous, well-organized data presentation.

The role requires a strong background in clinical development, regulatory guidelines (ICH/global standards), and the ability to guide other writers toward timely, high-quality

Qualificações

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

Responsabilidades

• 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 communications.
• Participate in cross-functional meetings to provide input on deliverables and timelines.
• Review related project documents and contribute to process improvements.
• Oversee internal and contract medical writing resources to ensure timely delivery.

Conhecimentos

Regulatory writing

Project management

Cross-functional collaboration

Communication skills

Regulatory knowledge

Formação

Bachelor's degree

Advanced degree in scientific/regulatory field

Descrição da vaga

IQVIA is seeking a Principal Medical Writer to lead the development of regulatory documents for global submissions, providing strategic direction to cross-functional teams. You will oversee multiple compounds and serve as lead writer for final summaries, ensuring scientifically rigorous, well-organized data presentation.

The role requires a strong background in clinical development, regulatory guidelines (ICH/global standards), and the ability to guide other writers toward timely, high-quality