Scientist II, Clinical Regulatory Writing

🔥 2 minutes ago

🇮🇪 Ireland – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

✏️ Content Writer

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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 (CSRs), 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 • Incorporate reviewer feedback and manage version control across multiple stakeholders • Document timelines and ensure projects are delivered on time and on budget • Help shape Cardinal Health's first medical writing team in Ireland and establish new ways of working

🎯 Requirements

• Bachelor's or Master's degree in life science (e.g., biology, pharmacology, or biochemistry) • 2-3 years of clinical regulatory writing experience within the pharmaceutical, biotechnology, or CRO industry • Experience authoring and reviewing regulatory documents, Clinical Study Reports (CSRs), and protocols • Ability to understand clinical trial data, methodologies, and complex research • Exceptional writing, editing, and proofreading skills • Ability to work independently and as part of a team • Ability to work under pressure and meet challenging deadlines • Excellent interpersonal skills • English proficiency required • Proficiency in document management tools such as Veeva and MS Office

🏖️ Benefits

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