Scientist II, 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.

• →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.

• 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.

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