Scientist II, Clinical Regulatory Writing

Cardinal Health; Ireland; Presencial; EUR 65 000 - 90 000; Tempo integral

Resumo da oferta

Cardinal Health Ireland seeks an experienced regulatory writer to join our first medical writing team in Ireland, supporting client partnerships on clinical study reports, regulatory submissions, and CTD modules. You will collaborate with cross-functional teams and manage timelines.

The role requires a life science degree, 2–3 years in pharmaceutical writing, strong writing/editing skills, and the ability to work independently in a fast-paced environment.

Qualificações

• Bachelor's or Master's degree in life sciences (biology, pharmacology, biochemistry) required.
• 2–3 years of clinical regulatory writing experience in pharma/biotech/CRO.
• Experience authoring and reviewing regulatory documents and CSRs.
• Ability to interpret clinical trial data and complex methodologies.
• Excellent writing, editing and proofreading skills; able to work under pressure.
• Ability to work independently and within a team; meets tight deadlines.
• English proficiency is mandatory; strong interpersonal skills essential.
• Proficiency with document management tools such as Veeva and MS Office.

Responsabilidades

• Author, review, and edit regulatory documents including CSRs and study protocols.
• Support development of CTD Module 2 summaries and regulatory submissions.
• Ensure deliverables meet regulatory requirements and timelines.
• Incorporate reviewer feedback and manage version control across stakeholders.
• Document timelines and ensure on-time, on-budget project delivery.

Conhecimentos

Regulatory writing

CSR writing

Editing & proofreading

Independent worker

Deadline management

English proficiency

Interpersonal skills

Veeva

MS Office

Formação académica

Bachelor's or Master's in life sciences

Ferramentas

Veeva

MS Office

Descrição da oferta de emprego

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.

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.

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.