Scientist III, Clinical Regulatory Writing

Scientist III, Clinical Regulatory Writing### Scientist III, Clinical Regulatory Writing Apply:
Country-wide Remote:
Ireland-FIELD:
Full time:
Posted Today:
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…