Senior Medical Writer - Regulatory Submissions & Strategy

IQVIA Inc; Oeiras; On-site; EUR 60,000 - 90,000; Full time

Job summary

IQVIA 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 data is presented accurately and clearly according to regulatory standards.

The role requires a strong background in biopharmaceutical medical writing, experience with ICH guidelines, and the ability to manage timelines and resources with minimal supervision.

Qualifications

• Bachelor's degree required; advanced degree preferred.
• At least 5 years of medical writing experience in biopharmaceutical/CRO industry or similar.
• Proficiency in organizing and communicating clinical information with minimal oversight.
• Strong organizational, time management, and project management skills.
• Excellent verbal, written, and interpersonal communication; ability to work in a team.
• Knowledge of global regulatory requirements and therapeutic areas in all phases of clinical development.

Responsibilities

• Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH guidelines, standards and processes, and client authoring standards.
• Manage medical writing projects, including developing timelines and cross-functional communication to maintain review cycles.
• Participate in cross-functional meetings to provide input on deliverables and timelines.
• Review Protocols and Statistical Analysis Plans as appropriate.
• Participate in cross-functional process improvement initiatives and in writing SOPs.
• Manage internal and contract medical writing resources to ensure timely completion of assigned projects.

Skills

Medical writing

Regulatory writing

Project management

Team leadership

ICH guidelines

Education

Bachelor's degree

Advanced degree (preferred)

Job description

IQVIA 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 data is presented accurately and clearly according to regulatory standards.

The role requires a strong background in biopharmaceutical medical writing, experience with ICH guidelines, and the ability to manage timelines and resources with minimal supervision.