Scientist III, Clinical Regulatory Writing

Scientist III, Clinical Regulatory Writing### Scientist III, Clinical Regulatory WritingApply: Country-wide Remote: Ireland-FIELD: Full time: Posted Today: 20189811We 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 facilitiesWe 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. #J-18808-Ljbffr Cardinal Health