Senior Medical Writer - Lead Regulatory & Publications

ICON Clinical Research; Dublin; Presencial; EUR 75.000 - 110.000; Jornada completa

Descripción de la vacante

ICON plc is seeking a Senior Medical Writer to drive medical writing strategies and deliver regulatory documents and publications. You will lead creation, review and submission-ready documents and partner with global cross-functional teams to bring therapies closer to patients.

You will mentor junior writers, interpret complex trial data, and ensure compliance with ICH-GCP, FDA and EMA guidelines while thriving in a fast-paced environment.

Formación

• Bachelor’s degree in a relevant scientific field.
• Ability to interpret and summarize complex clinical data.
• Strong knowledge of regulatory requirements (ICH-GCP, FDA, EMA).
• Experience interacting with regulatory agencies during reviews.

Responsabilidades

• Lead the preparation, review, and editing of clinical study documents.
• Collaborate with cross-functional teams to interpret trial data.
• Plan and execute publication programs including abstracts and manuscripts.
• Mentor junior medical writers and foster excellence within the team.
• Support regulatory submissions with strategic scientific input.

Conocimientos

Medical writing

Regulatory writing

Data interpretation

Regulatory knowledge

Communication

Educación

Bachelor’s degree in a relevant scientific field

Descripción del empleo

ICON plc is seeking a Senior Medical Writer to drive medical writing strategies and deliver regulatory documents and publications. You will lead creation, review and submission-ready documents and partner with global cross-functional teams to bring therapies closer to patients.

You will mentor junior writers, interpret complex trial data, and ensure compliance with ICH-GCP, FDA and EMA guidelines while thriving in a fast-paced environment.