Remote Clinical Regulatory Writer – CSR & Protocols

Cardinal Health; Ennis Municipal District; Remote; EUR 60,000 - 90,000; Full time

Job summary

Cardinal Health Regulatory Sciences Ireland is seeking an experienced clinical regulatory writer to join our growing team. The role focuses on authoring, reviewing, and editing CSRs, protocols, and related regulatory documents for global submissions.

You will work with cross-functional teams to ensure accuracy, compliance, and timely delivery. The ideal candidate has 4+ years of regulatory writing experience in pharma/biotech/CRO, strong English communication, and knowledge of ICH, GCP, and

Qualifications

• 4+ years of clinical regulatory writing experience in pharma/biotech/CRO.
• Authoring and reviewing regulatory documents including CSRs and protocols.
• Understanding of regulatory submission requirements and drug development process.
• Ability to interpret complex clinical and scientific data clearly and compliantly.
• Working knowledge of ICH guidelines, GCP, FDA, EMA and global requirements.

Responsibilities

• Author, review, and edit regulatory documents with focus on CSRs, study protocols, amendments, and related documents; support CTD Module 2 summaries and Investigator Brochures.
• Provide content expertise to study and submission teams for regulatory filings.
• Collaborate with Clinical Operations, Biostatistics, Data Management, Pharmacovigilance, Medical Affairs, Regulatory Affairs, and other functions to ensure accurate data presentation.
• Contribute to data analysis planning and presentation strategies for CSRs and SAPs.
• Partner with Documentation Specialists to deliver submission-ready documents on time.
• Serve as SME in clinical regulatory writing and ensure compliance with global guidelines.

Skills

Regulatory writing

Clinical data interpretation

Stakeholder management

Cross-functional collaboration

ICH/GCP knowledge

English communication

Education

Bachelor's/Master's/PharmD/PhD in Pharmacy or related life sciences

Job description

Cardinal Health Regulatory Sciences Ireland is seeking an experienced clinical regulatory writer to join our growing team. The role focuses on authoring, reviewing, and editing CSRs, protocols, and related regulatory documents for global submissions.

You will work with cross-functional teams to ensure accuracy, compliance, and timely delivery. The ideal candidate has 4+ years of regulatory writing experience in pharma/biotech/CRO, strong English communication, and knowledge of ICH, GCP, and