Principal Medical Writer - FSP

About the role

IQVIA is looking for a Principal Medical Writer to develop clinical documents for submissions to regulatory authorities globally. The role gives strategic direction to cross-functional project teams with minimal oversight, ensuring documents such as Investigator's Brochures, Clinical Study Reports and marketing authorization submissions present accurate, consistent, data-driven clinical messages. The writer oversees medical writing across multiple compounds and acts as lead writer on individual summary documents.

Key responsibilities

• Develop regulatory documents for global regulatory agencies in line with ICH and other global guidelines, client authoring standards and project timelines.
• Manage medical writing projects, including timelines and communication with cross-functional teams about review cycles and expectations.
• Take part in cross-functional meetings and give input on deliverables, timelines and processes.
• Review related documents such as protocols and statistical analysis plans where appropriate.
• Help define and write standard operating procedures and best practices for preparing quality documents.
• Manage internal and contract medical writing resources to meet project deadlines.

Required profile

• Bachelor's degree; advanced degree in a relevant scientific, clinical or regulatory field preferred.
• At least 5 years of medical writing experience in the biopharmaceutical or CRO industry, or comparable experience in clinical or preclinical development.
• Strong organizational, time management and project management skills.
• Good verbal, written and interpersonal communication skills in a team environment.
• Knowledge of global regulatory requirements and of therapeutic areas in all phases of clinical development is desired.