Scientist III, Clinical Regulatory Writing

🔥 5 minutes ago

🇮🇪 Ireland – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

✏️ Content Writer

👻 Ghost score 10%

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Cardinal Health

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1971

📦 Logistics

🏭 Manufacturing

🏥 Healthcare

💰 $78M Post-IPO Debt on 2006-08

Logistics • Manufacturing • Healthcare

Cardinal Health is a global healthcare services and products company. It provides a comprehensive range of healthcare services, including medical supply distribution, pharmaceutical distribution, and logistics solutions to various healthcare facilities such as hospitals, community health centers, and ambulatory surgery centers. Additionally, Cardinal Health offers a variety of medical products and pharmaceutical services. The company also focuses on innovative solutions to enhance healthcare delivery, through services like patient support, pharmacy management, and advanced therapy solutions. Cardinal Health is committed to supporting healthcare providers in delivering quality patient care while optimizing operational efficiency.

📋 Description

• Author, review, and edit clinical regulatory documents, primarily Clinical Study Reports, clinical study protocols, protocol amendments, and related clinical development documents • Support 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 • Ensure deliverables meet regulatory requirements, internal quality standards, client expectations, and project timelines • Contribute scientific and strategic expertise to study and submission teams • Collaborate with Clinical Operations, Biostatistics, Data Management, Pharmacovigilance, Medical Affairs, Regulatory Affairs, and other cross-functional stakeholders • Contribute to data-analysis planning and presentation strategies for CSRs, including review of Statistical Analysis Plans and related documentation • Partner with Documentation Specialists and project teams to produce final documents, manage review cycles, incorporate feedback, maintain version control, and ensure timely delivery • Serve as a subject matter expert in clinical regulatory writing and ensure compliance with ICH, FDA, EMA, and other global regulatory guidelines

🎯 Requirements

• 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, or scientific areas strongly preferred • Proven ability to interpret and communicate complex clinical and scientific information clearly, concisely, and compliantly • 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

🏖️ Benefits

• Permanent role with long-term growth potential • Inclusive workplace that values diversity of thought, experience and background • Equal Opportunity employer