[Hiring] Scientist III, Medical Writing @Cardinal Health

Role Description

We are currently looking for Medical Writers in Ireland.

• Write, review, and/or edit clinical regulatory documents such as CTD Module 2 summaries and Clinical Overviews, Clinical study reports (CSRs), and other regulatory documents, as needed (e.g., Responses to Health Authority questions, Briefing Books, 120-day Safety updates, Pediatric Investigational Plans, or Investigator Brochures).
• Contribute scientifically and strategically to submission teams at the project and/or study team level to facilitate efficient development of high-quality clinical documents for regulatory filing (e.g., provide content expertise and guidance on regulatory requirements).
• Contribute to the planning of data analyses and presentation for CSRs; review statistical analysis plans and related documents.
• Work together with the in-house Documentation Specialist(s) to produce high-quality final documents and ensure timely delivery.
• Ensure all documents meet regulatory requirements, internal quality standards, and project timelines.
• Incorporate reviewer feedback and manage version control across multiple stakeholders.

Qualifications

• A Bachelor's, Master's, or PhD in life science (e.g., biology, pharmacology, or biochemistry).
• 3-5 years of regulatory/medical writing experience in the pharmaceutical industry across several therapeutics areas.
• Well-developed and proven medical writing skills.
• Must be able to translate complex medical information into clear, accurate content tailored to different audiences.
• Knowledge of regulatory document requirements and guidelines specific to ICH, FDA, and the EMA.
• The ability to work independently and as part of a team as well as under pressure meeting challenging deadlines.
• Excellent interpersonal skills.
• English proficiency required for this role.
• Proficiency in document management tools (e.g., Veeva, MS Office).

Requirements

• #LI-Remote
• Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Company Description

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/Affirmative Action 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.