Senior Medical Writer - Regulatory Submissions (Remote)

ICON; Swansea; Sur place; GBP 40 000 - 60 000; Plein temps

Avantages offerts par ce poste

Annual leave

Health insurance

Retirement planning

Employee assistance

Résumé du poste

ICON plc is seeking a Medical Writer II to lead the preparation of regulatory and clinical documents for submissions. You will coordinate assignments, provide substantive editing, and guide document strategy across therapeutic areas while ensuring compliance with industry standards.

The role requires a science/health degree and several years writing experience in pharma/biotech, including study reports, IBs, and protocols. Remote work options may be available.

Qualifications

• Bachelor’s degree in science or health profession is required.
• At least 3 years of pharma/biotech writing experience preferred.
• Experience with key documents like Clinical Study Reports, IBs, Protocols.

Responsabilités

• Lead writing for regulatory and clinical documents with coordination of writers.
• Prepare regulatory submissions and ensure regulatory guidance compliance.
• Provide editing and guidance on document content, style, and format.
• Represent Medical Writing on cross-functional teams and vendor interactions.

Connaissances

Medical writing

Regulatory writing

Team leadership

Communication

Formation

Bachelor’s degree in science/health professions

Outils

Electronic submissions

Description du poste

ICON plc is seeking a Medical Writer II to lead the preparation of regulatory and clinical documents for submissions. You will coordinate assignments, provide substantive editing, and guide document strategy across therapeutic areas while ensuring compliance with industry standards.

The role requires a science/health degree and several years writing experience in pharma/biotech, including study reports, IBs, and protocols. Remote work options may be available.