[Hiring] Scientist II, Clinical Regulatory Writing @Cardinal Health

Role Description

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.
• Support 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.
• 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).

Company Description

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