Scientist II, Clinical Regulatory Writing

Cardinal Health; Ennis Municipal District; Remote; EUR 55,000 - 90,000; Full time

Job summary

Cardinal Health Regulatory Sciences Ireland is expanding its first medical writing team. This permanent role offers long-term growth potential and remote work flexibility for a life science professional.

Your responsibilities include authoring and reviewing Clinical Study Reports and protocols, managing timelines, and collaborating with cross-functional teams to deliver high-quality regulatory documents on schedule.

Qualifications

• 2–3 years of clinical regulatory writing experience in pharma/biotech/CRO.
• Experience authoring and reviewing Regulatory documents and CSRs.
• Experience with protocols and clinical study documents.
• Ability to understand clinical trial data, methodologies and complex research.
• Excellent writing, editing and proofreading skills.
• Ability to work independently and in a team.
• Ability to work under pressure and meet deadlines.
• English proficiency required.
• Proficiency with document management tools (Veeva, MS Office).

Responsibilities

• Author, review and edit regulatory documents with a focus on CSRs and protocols, ensuring regulatory compliance and client expectations.
• Ensure documents meet regulatory requirements, quality standards and timelines.
• Incorporate reviewer feedback and manage version control across stakeholders.
• Document timelines and ensure on-time, on-budget project delivery.

Skills

Regulatory writing

CSR writing

Protocols writing

Independent work

Team collaboration

Editing/writing quality

English proficiency

Education

Bachelor's or Master's degree in life science

Tools

Veeva

MS Office

Job description

Country-wide Remote

Ireland-FIELD

Full time

20189813

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.

• Ensure all documents meet regulatory requirements, internal quality standards, and project timelines

• Incorporate reviewer feedback and manage version control across multiple stakeholders.

• Document timelines, ensuring projects are delivered on-time and on-budget.

Qualifications

• A 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.

• The ability to understand clinical trial data, methodologies, and complex research.

• Exceptional writing, editing, and proofreading skills.

• The ability to work independently and as part of a team.

• The ability to work under pressure and meet challenging deadlines.

• Excellent interpersonal skills.

• English proficiency required for this role.

• Proficiency in document management tools (e.g., Veeva, MS Office)

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 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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