Senior Medical Writer: Regulatory Strategy & Submissions

IQVIA; Barcelona; On-site; EUR 70,000 - 110,000; Full time

Job summary

IQVIA is seeking a Principal Medical Writer in Barcelona to lead the development of regulatory documents for global submissions (IBs, CSRs, and TARs). You will ensure data-driven messages are clear, accurate, and compliant with ICH guidelines and client standards, delivering high-quality manuscripts on schedule.

You will mentor other writers, coordinate cross-functional input, and oversee multiple compounds while maintaining scientific rigor and consistency across programs and regulatory

Qualifications

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

Responsibilities

• Develop regulatory documents for submission to regulatory agencies globally, complying with ICH and client standards and project timelines.
• Manage medical writing projects, including timelines and cross-functional communications.
• Participate in cross-functional meetings to provide input on deliverables and processes.
• Review associated documents (e.g., Protocols, Statistical Analysis Plans) as appropriate.
• Support cross-functional process improvements and SOP development for quality documents.
• Contribute to standard operating procedures and best practices for efficient document preparation.
• Manage internal and contract medical writing resources to ensure timely completion of projects.

Skills

Medical writing

Regulatory writing

Project management

Cross-functional collaboration

Organizational skills

Time management

Team leadership

Education

Bachelor's degree

Advanced degree in a relevant field

Job description

IQVIA is seeking a Principal Medical Writer in Barcelona to lead the development of regulatory documents for global submissions (IBs, CSRs, and TARs). You will ensure data-driven messages are clear, accurate, and compliant with ICH guidelines and client standards, delivering high-quality manuscripts on schedule.

You will mentor other writers, coordinate cross-functional input, and oversee multiple compounds while maintaining scientific rigor and consistency across programs and regulatory