Scientist III, Clinical Regulatory Writing

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.

• 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.

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• →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.