Senior Medical Writer — Regulatory Submissions Lead

IQVIA; Zaventem; Vor Ort; EUR 70.000 - 110.000; Vollzeit

Zusammenfassung

IQVIA is seeking a Principal Medical Writer to lead the development of regulatory documents for global submissions. You will guide cross-functional teams, ensuring scientifically rigorous, data-accurate, and well-presented documents such as IBs, CSRs, and submission dossiers.

You will oversee the writing of summary documents, manage timelines, and contribute to process improvements across multiple compounds. A strong background in clinical development and regulatory standards is essential.

Qualifikationen

• Bachelor's degree required. Advanced degree in a relevant scientific/clinical/regulatory field preferred.
• At least 5 years of medical writing experience in biopharmaceutical/CRO industry or comparable clinical/preclinical development experience.
• Proficiency in organizing and communicating clinical information with minimal oversight.
• Strong organizational, time management, and project management skills.
• Strong verbal, written, and interpersonal communication skills for team work.
• Knowledge of global regulatory requirements and therapeutic areas across all phases of development.

Aufgaben

• Develop regulatory documents for submission to regulatory agencies globally, aligning with ICH guidelines and client standards.
• Manage medical writing projects, including timelines and cross-functional communication.
• Participate in cross-functional meetings to provide input on deliverables and timelines.
• Review related documents (Protocols, Statistical Analysis Plans) as appropriate.
• Contribute to cross-functional process improvement initiatives.
• Help define and write SOPs and best practices for efficient document preparation.
• Oversee internal and contract medical writing resources to ensure on-time delivery.

Kenntnisse

Medical writing

Regulatory knowledge

Project management

Communication

Time management

Team collaboration

Ausbildung

Bachelor's degree

Advanced degree preferred

Jobbeschreibung

IQVIA is seeking a Principal Medical Writer to lead the development of regulatory documents for global submissions. You will guide cross-functional teams, ensuring scientifically rigorous, data-accurate, and well-presented documents such as IBs, CSRs, and submission dossiers.

You will oversee the writing of summary documents, manage timelines, and contribute to process improvements across multiple compounds. A strong background in clinical development and regulatory standards is essential.