[Hiring] Scientist III, Clinical Regulatory Writing @Cardinal Health

Role Description

This opportunity offers the chance to join and help shape our first medical writing team in Ireland supporting a strategic long-term client partnership. While the position is a permanent role with long-term growth potential, the initial phase may involve evolving processes, changing priorities, and the opportunity to establish new ways of working. We are looking for individuals who thrive in dynamic and fast-paced environments and are comfortable navigating ambiguity and helping build processes from the ground up.

• Author, review, and edit clinical regulatory documents with a primary focus on Clinical Study Reports (CSRs), clinical study protocols, protocol amendments, and related clinical development documents.
• Support the development of CTD Module 2 summaries, Clinical Overviews, Investigator Brochures, briefing books, responses to Health Authority questions, safety updates, Pediatric Investigation Plans, and other regulatory submission documents as needed.
• 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.
• Collaborate with Clinical Operations, Biostatistics, Data Management, Pharmacovigilance, Medical Affairs, Regulatory Affairs, and other cross-functional stakeholders.
• Contribute to the planning of data analyses and presentation strategies for CSRs, including the review of Statistical Analysis Plans (SAPs).
• Partner with in-house Documentation Specialists and project teams to produce high-quality final documents.
• Serve as a subject matter expert in clinical regulatory writing, ensuring compliance with applicable ICH, FDA, EMA, and other global regulatory guidelines.

Qualifications

• 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, Clinical Study Reports (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.

Company Description