Scientist III, Clinical Regulatory Writing

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

Country-wide Remote

Ireland-FIELD

Full time

20189811

We are a team of nearly 48,000 mission-driven partners striving each day to advance healthcare and improve lives. Headquartered in Dublin, Ohio, Cardinal Health, is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for healthcare facilities

We are a crucial link between the clinical and operational sides of care, working with more than 4,500 sourcing and manufacturing partners to deliver end-to-end solutions and data-driven insights that advance healthcare and improve lives every day. With deep partnerships, diverse perspectives and innovative digital solutions, we build connections across the continuum of care.

With more than 50 years in business, operations in 30 countries and approximately 46,500 employees globally, Cardinal Health is Essential to Care.

What Regulatory Sciences contributes to Cardinal Health

For over four decades, our industry-trained regulatory consultants have provided expertise and guidance to help pharmaceutical, biotechnology, and medical device companies get their products to market. Our regulatory and product development strategies are designed to reduce the risk of failure and increase financial returns on your research investments. We provide efficient scientific and regulatory consulting services throughout the full product lifecycle to help ensure the continued success of your product post-approval.

The medical writers at Cardinal Health Regulatory Sciences summarize data into concise and accurate reports in formats that comply with regulatory agency requirements and client expectations. We author all types of regulatory and non‑regulatory documents (all stages), including eCTD summary documents, clinical study reports, patient narratives, clinical study protocols, manuscripts, Investigator Brochures, and briefing books, among others.

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.

Key Responsibilities

• 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, while also supporting 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 to support the efficient 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 the review of Statistical Analysis Plans (SAPs) and related documentation to ensure accuracy across the different study documents.


• Partner with in-house 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 other global regulatory guidelines across all assigned projects.

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.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

To read and review this privacy notice click here (https://www.cardinalhealth.com/content/dam/corp/email/documents/corp/cardinal-health-online-application-privacy-policy.pdf)

Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for healthcare facilities.

We are a crucial link between the clinical and operational sides of healthcare, delivering end‑to‑end solutions and data‑driving insights that advance healthcare and improve lives every day. With deep partnerships, diverse perspectives and innovative digital solutions, we build connections across the continuum of care.

With more than 50 years of experience, we seize the opportunity to address healthcare's most complicated challenges — now, and in the future.

View Cardinal Health on YouTube (http://youtube.com/user/CardinalHealth)

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