Senior Medical Writer: Regulatory Docs & Mentorship (Remote)

ICON Clinical Research; España; Remote; EUR 60.000 - 90.000; Vollzeit

Benefits dieser Stelle

Annual leave

Health insurance

Retirement planning

Employee Assistance Program

Life assurance

Flexible benefits

Zusammenfassung

ICON Clinical Research is seeking a Senior Medical Writer to lead medical writing strategies for clinical projects. You will own regulatory documents, contribute to protocol and CSR development, and mentor junior writers while coordinating with study teams to meet timelines.

The role requires strong regulatory expertise, high-quality writing, and collaboration across cross-functional teams to ensure submission readiness and regulatory compliance in a sponsor-dedicated environment.

Qualifikationen

• 3–5 years of experience as regulatory writer.
• Mandatory protocol writing experience in phase II or III; CSR experience is a plus.
• Bachelor's degree in a relevant scientific discipline.
• Ability to interpret and summarize complex clinical data with strong writing skills.
• Solid understanding of regulatory requirements (ICH-GCP, FDA, EMA) and agency interactions.

Aufgaben

• Lead development and execution of medical writing strategies for clinical projects.
• Independently produce clinical/regulatory documents (e.g., protocols, CSR).
• Analyse data and apply lean writing to documents.
• Serve as the study team's primary contact for document planning and timelines.
• Mentor junior medical writers and promote best practices within the team.

Kenntnisse

Regulatory writing

Clinical data interpretation

Editing & proofreading

Team collaboration

Regulatory agency interactions

Ausbildung

Bachelor's degree in a scientific field

Jobbeschreibung

ICON Clinical Research is seeking a Senior Medical Writer to lead medical writing strategies for clinical projects. You will own regulatory documents, contribute to protocol and CSR development, and mentor junior writers while coordinating with study teams to meet timelines.

The role requires strong regulatory expertise, high-quality writing, and collaboration across cross-functional teams to ensure submission readiness and regulatory compliance in a sponsor-dedicated environment.