Senior Clinical Regulatory Writer (CSR Focus)

858 Cardinal Health Ireland 508 Limited; Ireland; Vor Ort; EUR 70.000 - 95.000; Vollzeit

Benefits dieser Stelle

Inclusive workplace

Diversity focus

Zusammenfassung

Cardinal Health Regulatory Sciences Ireland is seeking an experienced clinical regulatory writer to join our first medical writing team in Ireland. The role focuses on authoring and editing CSRs, protocols, and related regulatory documents to support regulatory submissions for a strategic long-term client partnership.

You will collaborate with Clinical Operations, Biostatistics, Data Management, and other stakeholders to ensure accuracy, compliance, and timely delivery of submission-ready

Qualifikationen

• Bachelor’s, Master’s, PharmD, or PhD in Pharmacy, Pharmacology, Life Sciences, Biomedical Sciences, or a related scientific discipline.
• 4+ years of clinical regulatory writing experience within the pharmaceutical, biotechnology, or CRO industry.
• Significant hands-on experience authoring and reviewing Regulatory documents, CSRs and Protocols.
• Strong understanding of the clinical drug development process and regulatory submission requirements.
• Experience working in a pharmaceutical environment or a background in pharma, clinical, scientific areas is strongly preferred.
• Proven ability to interpret and communicate complex clinical and scientific information in a clear, concise, and compliant manner.
• Working knowledge of ICH guidelines, GCP, FDA, EMA, and global regulatory requirements.
• Ability to independently manage multiple writing projects and meet demanding timelines.
• Strong stakeholder management and cross-functional collaboration skills.
• Excellent written and verbal communication skills in English.

Aufgaben

• Author, review, and edit clinical regulatory documents with a primary focus on CSRs, clinical study protocols, protocol amendments, and related clinical development documents.
• Ensure all deliverables meet regulatory requirements, internal quality standards, client expectations, and project timelines.
• Contribute scientifically and strategically to study and submission teams, providing content expertise and guidance on regulatory requirements to support the development of high-quality clinical documents for regulatory filings.
• Collaborate with Clinical Operations, Biostatistics, Data Management, Pharmacovigilance, Medical Affairs, Regulatory Affairs, and other cross-functional stakeholders to ensure accurate interpretation, analysis, and presentation of clinical data.
• Contribute to the planning of data analyses and presentation strategies for CSRs, including SAPs and related documentation to ensure accuracy across study documents.
• Partner with Documentation Specialists and project teams to produce high-quality final documents, manage review cycles, incorporate stakeholder feedback, maintain version control, and ensure timely delivery of submission-ready documents.
• Serve as a subject matter expert in clinical regulatory writing, ensuring compliance with applicable ICH, FDA, EMA, and global regulatory guidelines across all assigned projects.

Kenntnisse

Regulatory writing

CSR writing

Regulatory submissions

Cross-functional collaboration

English proficiency

Ausbildung

Bachelor's degree in Pharmacy

Master's degree in Life Sciences

PharmD

PhD in related field

Jobbeschreibung

Cardinal Health Regulatory Sciences Ireland is seeking an experienced clinical regulatory writer to join our first medical writing team in Ireland. The role focuses on authoring and editing CSRs, protocols, and related regulatory documents to support regulatory submissions for a strategic long-term client partnership.

You will collaborate with Clinical Operations, Biostatistics, Data Management, and other stakeholders to ensure accuracy, compliance, and timely delivery of submission-ready